Initial Clinical Experiences of Robotic Distal Gastrectomy for Gastric Cancer Using the Da Vinci TM SP System

doi:10.21203/rs.3.rs-5006487/v1

Download PDF

Research Article

Initial Clinical Experiences of Robotic Distal Gastrectomy for Gastric Cancer Using the Da Vinci TM SP System

https://doi.org/10.21203/rs.3.rs-5006487/v1

This work is licensed under a CC BY 4.0 License

You are reading this latest preprint version

Purpose

Reduced-port surgery has been utilized in gastric cancer surgery but was not predominantly used due to its high technical difficulty. A new single-port surgical robot named da Vinci™ SP System (DVSP) was launched and eventually approved for clinical use in Japan in November 2022. We initiated robotic gastrectomy for gastric cancer using DVSP in March 2023. Here, we report our initial experiences and assessments of the feasibility and safety of robotic gastrectomy for gastric cancer using DVSP.

Methods

This single-center retrospective study included 20 patients with gastric cancer who underwent robotic gastrectomy with DVSP from March 2023 to April 2024. The primary endpoint was the postoperative complication rate within 30 days postoperatively. Secondary endpoints were surgical outcomes, including intraoperative adverse events, operative time, blood loss, and the number of dissected nodes.

Results

Of the 20 patients, 6 (30.0%) were male. The median age was 76.5 years. Tumors in the middle to lower stomach were observed in 20 patients (100.0%), including 18 (90.0%) and 2 (10.0%) with clinical stages I and II diseases, respectively. All patients underwent distal gastrectomy. The postoperative complications of Clavien–Dindo grade ≥ II occurred in 3 (15%) patients. Intraoperative adverse events, including conversion to other approaches, were not observed. All patients underwent R0 resection. The median operative and console times were 283.5 and 240 min, respectively. The median blood loss was 11.5 mL with 49 dissected nodes.

Conclusion

This study revealed the safe performance of robotic distal gastrectomy with standard lymphadenectomy for gastric cancer using DVSP.

Gastrectomy

Single-port surgery

Stomach neoplasms

Robotic surgical procedures

Gastric cancer ranked as the fourth-leading cause of global mortality based on 2020 data, and it continues to pose a significant health challenge [1]. The predominant approach for achieving curative outcomes involves R0 resection with appropriate lymph node dissection despite the increasing use of chemotherapy in its treatment [2]. Recent advancements in surgical techniques have spurred the rapid evolution of minimally invasive therapies for gastric cancer, including laparoscopic and robotic approaches [3]. Notably, the utilization of robotic technology, as improvements in short-term results in randomized controlled trials (RCTs) indicated, is slowly gaining momentum [3]. Da Vinci™ Surgical System (da Vinci, Intuitive Surgical, Sunnyvale, CA, USA) has dominated the field of surgical robotics for the past 20 years. However, various new surgical robots have been developed and launched in recent years with the development and spread of technology [4–6].

Reduced-port surgery, including a single-port approach, has been developed to further reduce the invasiveness of conventional laparoscopic surgery and has been reported in gastrectomy [7, 8]. Faster postoperative recovery and less analgesic administration were reported in single-port laparoscopic gastrectomy compared to the conventional multi-port laparoscopic approach [9], but the technical difficulty of the reduced-port approach has limited its predominant use because of the additional movement limitation by the short distance between ports in addition to the restricted range of motion by straight forceps, which is an issue in conventional laparoscopic surgery.

Da Vinci™ SP System (DVSP, Intuitive Surgical, Sunnyvale, CA, USA), in which four instruments, including the flexible endoscope, are bundled through a single port, was launched and eventually approved for clinical use in Japan in November 2022. We initiated robotic gastrectomy (RG) using multi-port da Vinci in 2009 and have conducted over 1000 RGs for gastric cancer. Furthermore, we previously reported that RG provided better surgical and comparable oncological outcomes than the conventional laparoscopic approach [10–12]. In our experience, problems with the multi-port model included the need to set targets for the surgical field, which must be re-targeted if they are exceeded, the occurrence of extracorporeal arm collision, and the difficulty in securing the optimal surgical field of view due to the rigid scope. We introduced DVSP in January 2023 to take advantage of the minimal invasiveness of reduced-port surgery while overcoming the technical disadvantages of conventional laparoscopic reduced-port approaches, and we performed the first RG for gastric cancer using DVSP in March 2023. This study aimed to investigate the feasibility and safety of RG for gastric cancer using DVSP.

Da Vinci™ SP System

DVSP has one arm on which four arms, including three forceps and the endoscope, are mounted, in contrast to the multi-port da Vinci that equips four arms, including one for the endoscope. Both systems have similar surgeon consoles and “leader-to-follower” manipulation (Fig. 1a). The instrument has an “elbow” joint in addition to the wrist joint. Similar to other instruments, the endoscope is articulated and changed from 0 to 30 degrees. Each elbow joint opens outward after the instruments pass through a trocar of approximately 3 cm in diameter, thereby creating a space of approximately 7 cm inside (Fig. 1b). Paying attention to the extracorporeal collision between the arms is necessary for the multi-port da Vinci. However, in DVSP, all the arms are combined into a single arm, so it cannot occur. However, care should be considered to avoid intracorporeal instrument collision due to the elbow joint, which is unique to DVSP. DVSP has a function that displays the position of the arms on the monitor because intracorporeal instrument collision during surgery usually occurs outside the view and cannot be seen. In terms of the endoscope, DVSP has two types of scope position: “above mode,” in which the endoscope is at the 12 O’clock position (ventral position) and ranges 0 to 30 degrees down, and “below mode,” in which the endoscope is at the 6 O’clock position (dorsal position) and ranges 0 to 30 degrees up. These two modes can be changed by revolving the arm intraoperatively. Additionally, the consoler manipulates the endoscope with three modes: “Adjustment mode” in which only the endoscope moves while the system automatically adjusts to keep the other instrument tips’ position, “Camera mode” in which only the scope moves and the other instruments are steady, and “Relocate mode” in which the trocar and all instruments, including the endoscope, moves.

Patients

This retrospective study was conducted with the approval of the institutional ethics committee (HM23-318). According to the Medical Care Act in Japan, initial robotic gastrectomies using the DVSP were executed as a highly difficult new medical technology [13] under the mandated prior review and sequential reporting requirements for operation records and case outcomes, including safety data. This study was conducted after obtaining approval from the Fujita Health University Evaluating Committee for Highly Difficult New Technologies (approval number: 23 − 13). All patients were treated following the Declaration of Helsinki. Demographic, clinicopathological, and treatment data were obtained from the prospectively maintained surgical gastric cancer database and electronic medical records at our institution. This study indicated DVSP for patients with clinical stages I or II distal gastric cancer for the first five cases, considering the safety of DVSP during the introductory phase. Additionally, patients receiving preoperative chemotherapy were contraindicated for DVSP. Surgical resection was indicated from February 2023 to March 2024, for 146 patients with pathologically confirmed gastric cancer. They were evenly offered DVSP, and other robotic approaches, including da Vinci Xi Surgical System (da Vinci Xi, Intuitive Surgical, Sunnyvale, CA, USA), conventional laparoscopic, or open approaches. This study then included consecutive 20 patients who agreed to undergo surgery with DVSP. All the remaining 126 patients underwent robotic gastrectomies using the other surgical robots including da Vinci Xi, hinotori™ Surgical Robot System (Medicaroid, Kobe, Japan), and Hugo™ RAS System (Medtronic, Minneapolis, MN, USA). Clinical and pathological tumor depth (T stage), lymph node status (N stage), and TNM stage were classified according to the Sixth edition of the Japan Gastric Cancer Association (JGCA) guidelines [2]. Our previous studies detailed the indications for physical function assessment, perioperative management, and postoperative chemotherapy, along with oncological follow-up [10, 11]. Three console surgeons (IU, KS, SS, and MN), with > 50 RG experiences using da Vinci and were qualified by the Japanese Society of Endoscopic Surgery (JSES) endoscopic surgical skill qualification system, participated as console surgeons in this study [14].

Position and Port Placement

Figure 2a illustrates the layout of the operating room. The patient was placed in a supine position with the legs apart and the left arm extended, with a 10°–15° head-up tilt. A 3-cm small incision was made at the umbilicus and a 12-mm trocar for the assistant was placed in the upper abdomen. An assistant port was placed on the patient’s left side if the Billroth-I gastroduodenostomy was planned, or on the patient’s right side if the Billroth-II gastrojejunostomy was planned, considering the optimal direction of the stapler in reconstruction (Fig. 2b). A 10-mmHg insufflation was initiated after placing a dedicated Access Port™ (Intuitive Surgical, Sunnyvale, CA, USA) over the incision. The patient cart was rolled in from the patient’s right side.

Instruments and Surgical Procedures

Maryland Bipolar Forceps (Intuitive Surgical, Sunnyvale, CA, USA), which were connected to a ForceTriad™ energy platform (Medtronic Inc, Minneapolis, MN, US), were used for the right hand and Fenestrated Bipolar Forceps (Intuitive Surgical, Sunnyvale, CA, USA) for the left hand. Round tooth retractor (Intuitive Surgical, Sunnyvale, CA, USA) was used as a retraction arm (Fig. 3). Four different patterns of instrument and endoscope layouts were employed based on the surgical situation (Fig. 4, 5). Internal Organ Retractor (B. Braun Aesculap, Tokyo, Japan) with a 2 − 0 nylon thread was applied to assist in surgical field deployment, and its position was changed depending on the surgical situation intraoperatively. The details of the surgical procedure have been previously reported [10, 15, 16]. In summary, the extent of gastrectomy and lymph node dissection was identified according to the JGCA treatment guidelines [2]. The outermost layer-oriented approach was used for lymph node dissection [15, 16]. D1 + lymph node dissection, including perigastric lymph nodes and those along the celiac trunk, left gastric, and common and proper hepatic arteries, was performed for patients with cT1N0 diseases. D2 lymph node dissection, including lymph nodes along the proximal splenic artery and portal vein, in addition to D1 + lymph nodes, was performed for patients with cT ≥ 2 N any diseases (Fig. 6). Intracorporeal Billroth-I or Billroth-II anastomosis using linear staplers was performed after distal gastrectomy. The console surgeons performed most procedures, excluding port placement, small clip clipping, and stomach and duodenal transection, using linear staplers by the assistant surgeons. The assistant surgeons used LigaSure™ (Medtronic Inc, Minneapolis, MN, US) or ENSEAL™ (Ethicon Inc, Raritan, NJ, USA) to divide thick tissue and vessels, DS clip™ (B Braun, Melsungen Germany), and laparoscopic suction-irrigation device (LAGIS Enterprise, Taichung, Taiwan) because of the unavailability of the vessel sealing system, small clip instrument, and suction-irrigation device in DVSP.

Advanced utilization of the elbow joints in combination with the wrist joints

There are two types of setups for conventional laparoscopic surgery: one is coaxial setup, and the other is para-axial setup. Especially in conventional laparoscopic surgery using a flexible scope, para-axial setup, in which the scope comes from the operating surgeon’s left or right side as if it were used in the coaxial setup (“pseudo-coaxial setup”), are commonly used to improve operating surgeon’s range of motion. In this regard, the abovementioned scope usage shown in Figs. 4 and 5, in which the scope was fixed at the 12 o’clock (above) or 6 o’clock (below), corresponds to the coaxial setup in multi-port da Vinci surgery (30° down/up) (Fig. 6a). In the meantime, by fully utilizing the Camera mode with the short entry guide rotation, para-axial “pseudo-coaxial” setup, which could not be achieved in multi-port da Vinci surgery due to its rigid scope, could be easily realized, leading to further improvement in operating surgeon’s range of motion in DVSP surgery. In this set up, the operating surgeon always used the Above mode with Fenestrated Bipolar Forceps (left hand), Maryland Bipolar Forceps (right hand), and Round tooth retractor. When the retraction arm was used to pull something up, the short entry guide was rotated in the counterclockwise direction (Fig. 6b), whereas it was rotated in the clockwise direction when it was used to pull and/or roll something down (Fig. 6c).

Measurements and Statistical Analyses

All patients were observed for at least 30 days postoperatively. The primary endpoint includes postoperative complication rates within 30 days postoperatively. Secondary endpoints involve short-term outcomes, including operative time, console time, blood loss, conversion to other approaches, the number of dissected nodes, and postoperative hospital stay. All grade ≥ II postoperative complications classified following the C–D classification [17] were recorded. The total operative time was the duration from the start of the abdominal incision to wound closure completion, and the console time was the duration of DVSP operation intraoperatively, including the time required to extract the resected specimen from the umbilical incision and redock for the reconstruction. The setup time starts during umbilical incision to console initiation, and the docking time was from roll-in to console start time. Blood loss was estimated by weighing suctioned blood and gauze pieces that had absorbed blood. Categorical variables are presented as numbers and percentages. Continuous variables are denoted as medians and ranges. Statistical Package for the Social Sciences version 28.0 (IBM Corp., Armonk, NY, USA) was used for all analyses.

Table 1 shows the clinicopathological characteristics of the patients. Of the 20 patients, 6 (30.0%) were male. The median age was 76.5 years (range, 30–83 years) and the body mass index was 20.7 kg/m² (range, 13.8–27.4 kg/m²). All patients had tumors in the middle to lower stomach. Clinical stage I and II diseases were found in 18 (90.0%) and 2 (10.0%) patients, respectively. Table 2 presents the surgical outcomes. Of the 20 patients, 20 (100%) and 5 (25.0%) underwent distal gastrectomy and D2 lymph node dissection, respectively. Intraoperative adverse events or conversion to other approaches were not observed. The total operative and console times were 283 min (range, 195–462 min) and 240 min (range, 149–355 min), respectively. The setup time measured from skin incision to start of the console was 15.5 min (range, 11–53 min), and the docking time measured from roll-in to start of the console was 5 min (range, 2–8 min). The median blood loss was 11.5 mL (range, 1–180 mL). The organ retractor was useful for creating large surgical fields, which replaced the role of the assistant surgeon and resulted in the smooth use of clipping devices and advanced energy devices by the assistant surgeon. Regarding instrumentation position, above 1 was the most commonly used in many situations; above 2 was useful at the suprapancreatic dissection when the gastropancreatic folds were elevated with an organ retractor; above 3 was useful in the infrapyloric dissection and below was applied in the greater curvature part. Table 3 summarizes pathological and postoperative outcomes. Postoperative complications of C–D grade ≥ II were observed in 3 (15%) patients. Postoperative complications of C–D grade Ⅲa were observed in 1 (5.0%) patient, and none had C–D grade IIIb or higher complications. No reoperation or surgical mortality was recorded. All patients underwent R0 resection. The median number of lymph nodes retrieved was 49 (range, 27–85), and the length of postoperative hospital stay was 10 days (range, 8–53 days). None of the patients were readmitted within 30 days post-discharge. The video review confirmed the completion of scheduled gastrectomy with lymphadenectomy in all patients (Fig. 7). Supplemental video 1 presents the operation video.

Table 1

Patients’ demographic and clinical characteristics
Case	Age	Sex	BMI	ASA	Location	Histology	Differentiation	cTN stage	cStage
1	66	F	21.6	2	M	sig	sig	T1bN-	I
2	70	F	21.5	1	M	por	poor	T1bN-	I
3	41	F	25.8	1	M	por	poor	T1bN-	I
4	69	M	22.8	2	M	sig	sig	T1bN-	I
5	77	F	19.2	2	L	por	poor	T3N-	IIB
6	65	M	26.2	2	M	tub	well	T1bN-	I
7	73	F	13.8	2	L	por	poor	T3N-	IIB
8	78	F	27.4	2	L	tub	mod	T1bN-	I
9	83	F	20.7	3	ML	por	poor	T2N-	I
10	77	F	22.8	2	L	tub	mod	T1bN-	I
11	59	F	18.3	2	M	por	poor	T1bN-	I
12	81	F	25.5	2	L	tub	mod	T2N-	I
13	76	F	14.5	2	M	tub	mod	T1bN-	I
14	79	M	18.1	2	L	tub	mod	T1bN-	I
15	75	F	22.8	2	M	sig	sig	T1bN-	I
16	30	F	20.7	2	M	tub	mod	T1aN-	I
17	68	M	19.4	2	L	tub	mod	T1bN-	I
18	80	M	25.1	2	M	tub	well	T2N-	I
19	73	M	20.4	2	M	tub	mod	T2N-	I
20	77	F	22.8	2	M	tub	well	T1bN-	I
ASA, American Society of Anesthesiologists physical status; M, male; F, female, U, upper stomach; M, middle stomach; L, lower stomach

Table 2

Surgical outcomes
Case	Operator	Type of gastrectomy	Lymphadenectomy	Reconstruction	Operative time	Console time	Set-up time	Docking time	Blood loss
1	1	Distal	D1+	B-I	378	224	17	5	9
2	1	Distal	D1+	B-II	337	273	9	8	64
3	1	Distal	D1+	B-I	263	197	18	3	2
4	1	Distal	D2	B-I	333	274	10	7	11
5	2	Distal	D2	B-I	293	246	17	6	10
6	2	Distal	D1+	B-I	356	311	14	3	46
7	2	Distal	D2	B-I	284	240	21	2	14
8	3	Distal	D1+	B-I	248	200	18	5	10
9	2	Distal	D2 + 14v	B-II	351	316	12	4	5
10	3	Distal	D1+	B-I	270	221	26	5	44
11	3	Distal	D1+	B-II	250	221	11	2	6
12	3	Distal	D1+	B-I	250	216	15	6	28
13	4	Distal	D1+	B-I	303	240	19	4	36
14	4	Distal	D1+	B-I	340	271	19	5	1
15	2	Distal	D1+	B-I	283	248	12	2	46
16	4	Distal	D1+	B-I	351	282	15	7	11
17	4	Distal	D1+	B-I	462	355	53	8	180
18	1	Distal	D1+	B-II	275	296	16	7	23
19	3	Distal	D2	B-I	248	214	14	4	10
20	1	Distal	D1+	B-II	195	149	13	5	12
B-I, Billroth I; B-II, Billroth II

Table 3

Pathological and postoperative findings
Case	Dissected lymph nodes	pTN stage	pStage	Hospital stay	Postoperative complications (C–D grade)
1	66	T1aN0	IA	12	None
2	79	T1aN0	IA	16	None
3	73	T1bN0	IA	14	None
4	36	T4aN3b	Ⅳ	13	None
5	32	T4aN0	IIB	13	None
6	74	T1bN0	IB	14	None
7	55	T2N2	IIB	56	Anastomotic stenosis (I)
8	38	T1aN0	IA	12	None
9	85	T4aN1	IIIA	11	None
10	64	T1bN0	IA	13	None
11	64	T1aN0	IA	13	Afferent loop syndrome (Ⅲa)
12	27	T1aN0	IA	15	None
13	53	T1aN0	IA	18	Pleural effusion (Ⅱ)
14	47	T1aN0	IA	29	Chyle ascites (I)
15	48	T1aN0	IA	17	Enteritis (Ⅱ)
16	50	T1aN0	IA	11	None
17	39	T1aN0	IA	13	None
18	27	T2N0	IB	11	None
19	50	T1aN0	IA	18	None
20	33	T1aN0	IA	13	None

This study reveals the safe introduction of robotic distal gastrectomy with standard lymph node dissection for clinical stage I or II gastric cancer using the DVSP. The rate of C–D grade ≥ II complications was 15%, whereas one (5%) case of C–D grade IIIa or higher complications in this study. The incidence of complications in RG for gastric cancer using the multi-port da Vinci has been 1.3–5.3% for grade IIIa or higher and 8.8–9.2% for grade II or higher in several studies, including RCTs and our previous research [12, 18–22]. Only one single-arm study has been reported for gastrectomy using DVSP, in which Park et al. revealed short-term outcomes of 19 cases in 2023, with no postoperative complications C–D grade IIIa or higher, and overall complications of 26.3% [6]. This study has a limited number of cases, but at least short-term outcomes are comparable, indicating the safe clinical introduction of RG for GC using DVSP.

The primary feature of DVSP is the single-port surgery that bundles four instruments into one port. Conventional laparoscopic single-port surgery or reduced-port surgery has been reported to result in smaller incisions, as well as minimal intra-abdominal manipulation causing reduced inflammatory response, decreased postoperative pain, faster recovery, shorter hospital stay, and higher satisfaction regarding scar appearance [8, 23–25]. Additionally, no significant difference in the number of lymph node dissections compared to multi-port laparoscopic approaches has been reported, indicating oncological equivalence [8]. However, it has not been widely applied due to the technical difficulty. The DVSP using the coaxial and the para-axial setups has console operability similar to or even better than that of the multi-port da Vinci, which may reduce the technical difficulty of single-port surgery. This single-arm study did not compare DVSP with a multi-port, and no studies have compared DVSP with a multi-port in gastrectomy. However, DVSP has demonstrated shorter operative and docking times compared with a multi-port in rectal resection and cholecystectomy [26, 27]. Moreover, less postoperative pain and shorter postoperative hospital stays in colon resection have been reported [28]. Postoperative complications were comparable in all the above-mentioned three studies [26–28]. RG generally exhibits longer operative times compared to the laparoscopic approach, partly due to the setup of the robotic system [22]. In this study, the average setup time of DVSP was 15 min, indicating the potential for reducing operative times in the future. Further studies comparing DVSP and multi-port in gastrectomy should be conducted in the future as more cases are accumulated.

The collision of instruments and arms is one limitation of the da Vinci Surgical System. We have previously published methods to prevent instrument collision outside and inside the abdominal cavity, named the “da Vinci’s plane theory” and the “monitor quadrisection theory”, respectively [10]. Instruments are bundled into one port with DVSP; thus, no extracorporeal arm collision occurs, and only intra-abdominal instrument collisions are to be considered. Furthermore, DVSP instruments have elbows and are curved in the abdominal cavity, which complicates instrument positioning. The DVSP displays the instrument layout on the monitor in real-time, which is also helpful, but one method for preventing intra-abdominal instrument collision is the “monitor quadrisection theory,” which we introduced with the multi-port da Vinci system [10]. This theory divides the monitor into four quadrants, and each part is utilized by each instrument inserted from the same side. This theory was valid for DVSP. Intracorporeal collision of the instrument was minimized when operating to the extent that the tips of the DVSP instruments on the monitor coincided with the placement of the cells in the short entry guide into which they were each inserted. DVSP allows instrument placement to be easily changed intraoperatively. Several instrument arrangements were used for different parts of the surgical procedure in the coaxial setup, which may have prevented instrument collision and enabled the safe performance of surgical procedures. In the para-axial setup, it was possible to extensively utilize the “monitor quadrisection theory” to further increase the mobility of the instruments by rotating the entire four instruments, while maintaining the horizontal position of the field of view using scope flexibility via the Camera mode. Additionally, the instruments via the assistant port could avoid collision with the operating surgeon’s forceps, as long as the operating surgeon folded its elbow joint in the lower quadrant of the assistant port side. Furthermore, the Relocate mode allowed the operating surgeon to always manipulate the surgical robot at its best maneuverable position (infinite da Vinci’s plane). Although the small range of motion of each instrument in DVSP sometimes disabled creating a large surgical field, use of the Internal Organ Retractor was helpful in such situations. Use of Internal Organ Retractor also let assistant surgeons less likely to participate in creating the surgical field, and thus more focus on using energy devices and clips instead.

Advanced energy devices, such as vessel sealing systems and ultrasonic coagulation devices, as well as small clips, are not equipped as of April 2024. The use of DVSP spreads not only in gastric resection but also in other fields. Comparisons with the multi-port da Vinci for colorectal cancer [26, 28–31], pancreatic resection [32–34], cholecystectomy [35], gynecology [36, 37], and urology [38] have been reported. Accumulating such clinical experiences may contribute to developing a new equipment. The present study added an assistant port, but the assistant port may become unnecessary if the role of the assistant decreases with various devices, resulting in a true single-port surgery.

This study has several limitations. This was a single-center case series with a small sample size. Additionally, all patients in this study had clinical stage I/II diseases and underwent distal gastrectomy. Moreover, patients receiving preoperative chemotherapy were contraindicated for DVSP during the study period. Accumulation of clinical series with advanced diseases and further investigations are warranted to identify the safety and feasibility of RG with DVSP from both surgical and oncological standpoints.

This study revealed the safe performance of robotic distal gastrectomy with standard lymphadenectomy for gastric cancer using DVSP.

robotic gastrectomy

da Vinci

da Vinci™ Surgical System

RCTs

randomized controlled trials

Gastric Cancer Association

JSES

Japanese Society of Endoscopic Surgery

C–D

Clavien–Dindo

Funding: This work was not supported by any grants or funding.

Acknowledgments We thank Maruzen Co., Ltd. (Tokyo, Japan) for the English language editing.

Authors’ Contributions: All authors have fully satisfied the ICMJE authorship criteria as detailed in the following: Study design: Ayaka Ito, Masaya Nakauchi, Ichiro Uyama, and Koichi Suda; Data collection: Ayaka Ito, Masaya Nakauchi, Susumu Shibasaki, Yusuke Umeki, Akiko Serizawa, Kazumitsu Suzuki, Yusuke Watanabe, Masahiro Fujita, and Tsuyoshi Tanaka; Statistical analyses and interpretation: Ayaka Ito, Masaya Nakauchi, Susumu Shibasaki, Masahiro Fujita, Yusuke Umeki, Yusuke Watanabe, Shingo Akimoto, Kazuki Inaba, and Koichi Suda; Drafting of the manuscript: Ayaka Ito, Masaya Nakauchi, and Koichi Suda; Critical revision of the manuscript for important intellectual content: Masaya Nakauchi, Ichiro Uyama, and Koichi Suda. All authors have read and approved the ﬁnal version of the manuscript and are accountable for all aspects of the work, particularly ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Disclosures: Ayaka Ito, Masaya Nakauchi, Susumu Shibasaki, Yusuke Umeki, Kazumitsu Suzuki, Masahiro Fujita, Akiko Serizawa, Shingo Akimoto, Yusuke Watanabe, Tsuyoshi Tanaka, Kazuki Inaba, Ichiro Uyama, and Koichi Suda have no commercial associations or financial involvement that might be construed as a conflict of interest in connection with the submitted article. Yusuke Watanabe received honoraria from Covidien Japan, Central Uni, and AMCO outside the submitted study. Yusuke Watanabe also has a collaborative research project with TOPPAN Inc., Central Uni CO., LTD., EBM Corporation, NISHIKAWA Co., Ltd., and SAKURA SEIKI Co., Ltd. outside the submitted work. Ichiro Uyama has received lecture fees from Intuitive Surgical, Inc., outside of the submitted work. Ichiro Uyama has been funded by Medicaroid, Inc. in relation to the Collaborative Laboratory for Research and Development in Advanced Surgical Technology, Fujita Health University. Koichi Suda has been funded by Sysmex, Co. in relation to the Collaborative Laboratory for Research and Development in Advanced Surgical Intelligence, Fujita Health University, and has also received advisory fees from Medicaroid, Inc., outside of the submitted work.

Availability of data: All data are presented in this manuscript.

Code availability: Not applicable.

Ethics approval: This study was performed in line with the principles of the Declaration of Helsinki. The present study was approved by the Institutional Review Board of Fujita Health University (HM23-318).

Ferlay J, Colombet M, Soerjomataram I, Parkin DM, Piñeros M, Znaor A, Bray F (2021) Cancer statistics for the year 2020: An overview. Int J Cancer
Japanese gastric cancer Association (2023) Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition). Gastric Cancer 26:1–25
Shibasaki S, Suda K, Hisamori S, Obama K, Terashima M, Uyama I (2023) Robotic gastrectomy for gastric cancer: systematic review and future directions. Gastric Cancer 26:325–338
Nakauchi M, Suda K, Nakamura K, Tanaka T, Shibasaki S, Inaba K, Harada T, Ohashi M, Ohigashi M, Kitatsuji H, Akimoto S, Kikuchi K, Uyama I (2022) Establishment of a new practical telesurgical platform using the hinotori™ Surgical Robot System: a preclinical study. Langenbecks Arch Surg 407:3783–3791
Bianchi PP, Salaj A, Rocco B, Formisano G (2023) First worldwide report on Hugo RAS™ surgical platform in right and left colectomy. Updates Surg 75:775–780
Park SH, Kim YN, Hwang J, Kim KY, Cho M, Kim YM, Hyung WJ, Kim HI (2023) Safety and feasibility of reduced-port robotic distal gastrectomy for gastric cancer: a phase I/II clinical trial using the da Vinci Single Port(SP) robotic system. Sci Rep 13:18578
Lin T, Mou TY, Hu YF, Liu H, Li TJ, Lu YM, Yu J, Li GX (2018) Reduced Port Laparoscopic Distal Gastrectomy with D2 Lymphadenectomy. Ann Surg Oncol 25:246
Omori T, Yamamoto K, Hara H, Shinno N, Yamamoto M, Sugimura K, Wada H, Takahashi H, Yasui M, Miyata H, Ohue M, Yano M, Sakon M (2021) A randomized controlled trial of single-port versus multi-port laparoscopic distal gastrectomy for gastric cancer. Surg Endosc 35:4485–4493
Omori T, Fujiwara Y, Moon J, Sugimura K, Miyata H, Masuzawa T, Kishi K, Miyoshi N, Tomokuni A, Akita H, Takahashi H, Kobayashi S, Yasui M, Ohue M, Yano M, Sakon M (2016) Comparison of Single-Incision and Conventional Multi-Port Laparoscopic Distal Gastrectomy with D2 Lymph Node Dissection for Gastric Cancer: A Propensity Score-Matched Analysis. Ann Surg Oncol 23:817–824
Suda K, Man IM, Ishida Y, Kawamura Y, Satoh S, Uyama I (2015) Potential advantages of robotic radical gastrectomy for gastric adenocarcinoma in comparison with conventional laparoscopic approach: a single institutional retrospective comparative cohort study. Surg Endosc 29:673–685
Nakauchi M, Suda K, Shibasaki S, Nakamura K, Kadoya S, Kikuchi K, Inaba K, Uyama I (2021) Prognostic factors of minimally invasive surgery for gastric cancer: Does robotic gastrectomy bring oncological benefit? World J Gastroenterol 27:6659–6672
Uyama I, Suda K, Nakauchi M, Kinoshita T, Noshiro H, Takiguchi S, Ehara K, Obama K, Kuwabara S, Okabe H, Terashima M (2019) Clinical advantages of robotic gastrectomy for clinical stage I/II gastric cancer: a multi-institutional prospective single-arm study. Gastric Cancer 22:377–385
Minamikawa K, Okumura A, Kokudo N, Kono K (2019) Regulation on introducing process of the highly difficult new medical technologies: A survey on the current status of practice guidelines in Japan and overseas. Biosci Trends 22:560–568
Mori T, Kimura T, Kitajima M (2010) Skill accreditation system for laparoscopic gastroenterologic surgeons in Japan. Minim Invasive Ther Allied Technol 19:18–23
Uyama I, Kanaya S, Ishida Y, Inaba K, Suda K, Satoh S (2012) Novel integrated robotic approach for suprapancreatic D2 nodal dissection for treating gastric cancer: technique and initial experience. World J Surg 36:331–337
Shibasaki S, Suda K, Nakauchi M, Nakamura T, Kadoya S, Kikuchi K, Inaba K, Uyama I (2018) Outermost layer-oriented medial approach for infrapyloric nodal dissection in laparoscopic distal gastrectomy. Surg Endosc 32:2137–2148
Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205–213
Kim HI, Han SU, Yang HK, Kim YW, Lee HJ, Ryu KW, Park JM, An JY, Kim MC, Park S, Song KY, Oh SJ, Kong SH, Suh BJ, Yang DH, Ha TK, Kim YN, Hyung WJ (2016) Multicenter Prospective Comparative Study of Robotic Versus Laparoscopic Gastrectomy for Gastric Adenocarcinoma. Ann Surg 263:103–109
Li ZY, Zhou YB, Li TY, Li JP, Zhou ZW, She JJ, Hu JK, Qian F, Shi Y, Tian YL, Gao GM, Gao RZ, Liang CC, Shi FY, Yang K, Wen Y, Zhao YL, Yu PW (2023) Robotic Gastrectomy Versus Laparoscopic Gastrectomy for Gastric Cancer: A Multicenter Cohort Study of 5402 Patients in China. Ann Surg 277:e87–e95
Lu J, Zheng CH, Xu BB, Xie JW, Wang JB, Lin JX, Chen QY, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Huang CM, Li P (2021) Assessment of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer: A Randomized Controlled Trial. Ann Surg 273:858–867
Ojima T, Nakamura M, Hayata K, Kitadani J, Katsuda M, Takeuchi A, Tominaga S, Nakai T, Nakamori M, Ohi M, Kusunoki M, Yamaue H (2021) Short-term Outcomes of Robotic Gastrectomy vs Laparoscopic Gastrectomy for Patients With Gastric Cancer: A Randomized Clinical Trial. JAMA Surg 156:954–963
Suda K, Yamamoto H, Nishigori T, Obama K, Yoda Y, Hikage M, Shibasaki S, Tanaka T, Kakeji Y, Inomata M, Kitagawa Y, Miyata H, Terashima M, Noshiro H, Uyama I (2022) Safe implementation of robotic gastrectomy for gastric cancer under the requirements for universal health insurance coverage: a retrospective cohort study using a nationwide registry database in Japan. Gastric Cancer 25:438–449
Du GS, Jiang EL, Qiu Y, Wang WS, Yin JH, Wang S, Li YB, Chen YH, Yang H, Xiao WD (2022) Single-incision plus one-port laparoscopic gastrectomy versus conventional multi-port laparoscopy-assisted gastrectomy for gastric cancer: a retrospective study. Surg Endosc 36:3298–3307
Kunisaki C, Miyamoto H, Sato S, Tanaka Y, Sato K, Izumisawa Y, Yukawa N, Kosaka T, Akiyama H, Saigusa Y, Sakamaki K, Yamanaka T, Endo I (2018) Surgical Outcomes of Reduced-Port Laparoscopic Gastrectomy Versus Conventional Laparoscopic Gastrectomy for Gastric Cancer: A Propensity-Matched Retrospective Cohort Study. Ann Surg Oncol 25:3604–3612
Omori T, Fujiwara Y, Yamamoto K, Yanagimoto Y, Sugimura K, Masuzawa T, Kishi K, Takahashi H, Yasui M, Miyata H, Ohue M, Yano M, Sakon M (2019) The Safety and Feasibility of Single-Port Laparoscopic Gastrectomy for Advanced Gastric Cancer. J Gastrointest Surg 23:1329–1339
Alshalawi W, Lee CS, Kim BC, Han SR, Kim IK, Bae JH, Lee IK, Lee D, Lee YS (2023) A comparative study on the short-term clinical outcomes of Da Vinci SP versus Da Vinci Xi for rectal cancer surgery. Int J Med Robot:e2558
Choi YJ, Sang NT, Jo HS, Kim DS, Yu YD (2023) A single-center experience of over 300 cases of single-incision robotic cholecystectomy comparing the da Vinci SP with the Si/Xi systems. Sci Rep 13:9482
Jung JM, Kim YI, Yoon YS, Yang S, Kim MH, Lee JL, Kim CW, Park IJ, Lim SB, Yu CS (2023) Short-term outcomes of da Vinci SP versus Xi for colon cancer surgery: a propensity-score matching analysis of multicenter cohorts. J Robot Surg 17:2911–2917
Jeong MH, Kim HJ, Choi GS, Song SH, Park JS, Park SY, Lee SM, Na DH (2023) Single-port versus multiport robotic total mesorectal excision for rectal cancer: initial experiences by case-matched analysis of short-term outcomes. Ann Surg Treat Res 105:99–106
Kim HS, Oh BY, Chung SS, Lee RA, Noh GT (2023) Trans-abdominal single-incision robotic surgery with the da Vinci SP® surgical system for 8 cases of retrorectal tumour. Int J Med Robot:e2599
Marks JH, Yang J, Spitz EM, Salem J, Agarwal S, de Paula TR, Schoonyoung HP, Keller DS (2023) A prospective phase II clinical trial/IDEAL Stage 2a series of single-port robotic colorectal surgery for abdominal and transanal cases. Colorectal Dis 25:2335–2345
Uchida Y, Takahara T, Nishimura A, Mii S, Mizumoto T, Iwama H, Kojima M, Uyama I, Suda K (2024) Robotic pancreatic tumor enucleation by the double bipolar technique using the da Vinci SP system: An initial case report with a technical detail. Asian J Endosc Surg 17:e13271
Choi YJ, Jo HS, Kim DS, Yu YD (2022) Single-port robot plus one port (SP + 1) distal pancreatectomy using the new da Vinci SP system. Langenbecks Arch Surg 407:1271–1276
Liu R, Liu Q, Zhao G, Zhao Z, Li M, Gao Y (2022) Single-port (SP) robotic pancreatic surgery using the da Vinci SP system: A retrospective study on prospectively collected data in a consecutive patient cohort. Int J Surg 104:106782
Kim WJ, Choi SB, Kim WB (2022) Feasibility and Efficacy of Single-Port Robotic Cholecystectomy Using the da Vinci SP® Platform. Jsls 26
Park SY, Cho EH, Jeong K, Yoo HK, Lee JH, Moon HS (2023) Robotic single-port hysterectomy versus robotic multisite hysterectomy in benign gynecologic diseases: A retrospective comparison of clinical and surgical outcomes. J Obstet Gynaecol Res 49:2746–2752
Seon KE, Lee YJ, Lee JY, Nam EJ, Kim S, Kim YT, Kim SW (2023) Comparing surgical outcomes of da Vinci SP and da Vinci Xi for endometrial cancer surgical staging in a propensity score-matched study. Sci Rep 13:11752
Morgantini LA, Alzein A, Bharadwaj A, Del Pino MS, Egan E, Ganesh A, Smith J, Crivellaro S (2024) A prospective study on single-port versus multiport patient-reported surgical outcomes. BJUI Compass 5:84–89

Supplemental video 1 is not available with this version.

No competing interests reported.

Download PDF

Reviews received at journal
12 Sep, 2024
Reviewers agreed at journal
04 Sep, 2024
Reviewers invited by journal
02 Sep, 2024
Editor assigned by journal
01 Sep, 2024
Submission checks completed at journal
31 Aug, 2024
First submitted to journal
30 Aug, 2024

You are reading this latest preprint version

Initial Clinical Experiences of Robotic Distal Gastrectomy for Gastric Cancer Using the Da Vinci TM SP System

Status:

Version 1

Abstract

Purpose

Methods

Results

Conclusion

Figures

Introduction

Materials and Methods

Da Vinci™ SP System

Patients

Position and Port Placement

Instruments and Surgical Procedures

Advanced utilization of the elbow joints in combination with the wrist joints

Measurements and Statistical Analyses

Results

Discussion

Conclusions

Abbreviations

Declarations

References

Supplemental Video

Additional Declarations

Status:

Version 1