Safety and Effectiveness of Ultrasound-Guided Artificial Ascites-Assisted Puncture and Sclerotherapy for Ovarian Cysts

doi:10.21203/rs.3.rs-4941075/v1

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Safety and Effectiveness of Ultrasound-Guided Artificial Ascites-Assisted Puncture and Sclerotherapy for Ovarian Cysts

https://doi.org/10.21203/rs.3.rs-4941075/v1

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Background

Ovarian cysts are a common gynecological condition that can cause significant morbidity. Ultrasound-guided sclerotherapy is a minimally invasive treatment option. This study aims to assess the safety and effectiveness of ultrasound-guided artificial ascites-assisted puncture and sclerotherapy for ovarian cysts.

Methods

A retrospective analysis was conducted on 100 ovarian cyst patients treated from January 2019 to June 2023 at Zhejiang Rongjun Hospital. Patients were divided into observation (44 cases) and control (56 cases) groups based on the use of artificial ascites. The primary endpoints included the incidence of pain and vagal reflex during and after surgery, and the cure rate and effective rate of sclerotherapy assessed by ultrasound at 3, 6, and 12 months post-treatment.

Results

The observation group experienced significantly lower rates of pain (11.36%) and vagal reflexes (4.55%) compared to the control group (35.71% and 25.00% respectively, P < 0.01). The cure rate was 93.18% in the observation group and 82.14% in the control group (P < 0.05). The effective rate was 100% in the observation group, while it was 91.07% in the control group (P < 0.05). No post-operative infections were observed in either group.

Conclusion

Ultrasound-guided artificial ascites-assisted puncture and sclerotherapy significantly enhances the safety and efficacy of sclerotherapy for ovarian cysts, reducing complications during and after the procedure. It is recommended for widespread clinical use.

Artificial Ascites

Ovarian Cysts

Sclerotherapy

Safety

Efficacy

Ovarian cysts are a common ailment affecting millions of women worldwide, particularly endometriosis-related ovarian cysts, which have seen an increasing incidence in recent years. Approximately 10–15% of women of reproductive age are impacted, affecting their fertility and causing persistent pain and other quality of life issues[1, 2]. Recent studies suggest that the prevalence of ovarian cysts has been increasing due to better diagnostic techniques and increased awareness among the population[3, 2, 4].

While laparoscopic surgery is a common treatment known for its minimal invasiveness, it risks damaging ovarian reserve, especially after multiple operations, potentially leading to premature ovarian insufficiency[5–8]. Despite being minimally invasive, laparoscopic surgery may not always be the optimal approach for recurrent cysts due to its potential for significant postoperative adhesions[9–11].

Traditional treatment modalities like laparoscopic surgery, despite their efficacy, pose risks due to their invasive nature and high costs, driving the need for safer and more economical alternatives. Ultrasound-guided cyst sclerotherapy, a less invasive and cheaper method involving the injection of sclerosing agents to reduce cyst size, has proven effective in multiple studies[12–14].

However, this technique has limitations, particularly when cysts are deeply located or near vital organs, increasing the risk of accidental damage and complications such as pain and vagal reflexes[15]. These complications significantly limit its clinical applicability, and there is a growing interest in techniques that can reduce these risks.

Artificial ascites, a technique involving the injection of saline solution into the peritoneal cavity under ultrasound guidance, can improve safety by distancing the target lesion from vital organs and creating a safer path for needle insertion[16, 17]. Preliminary studies and clinical practice both domestically and internationally suggest that this method can significantly reduce the risks of intraoperative injuries and decrease pain and vagal reflex incidents, thereby enhancing patient comfort and treatment acceptability[15, 18].

Although artificial ascites is widely used in the ablation treatment of liver tumors, existing literature on its use in cyst treatment is scarce, especially regarding prospective controlled studies that conclusively demonstrate its effectiveness. Therefore, this study aims to address this gap by evaluating the safety and efficacy of artificial ascites in ultrasound-guided sclerotherapy for ovarian cysts. Given the promising potential of artificial ascites to improve procedural safety and efficacy, this study will provide valuable insights into its clinical applicability in treating ovarian cysts.

Study Design

This retrospective cohort study analyzed 100 patients who underwent ultrasound-guided sclerotherapy for ovarian cysts at Zhejiang Rongjun Hospital from January 2019 to June 2023. The study aimed to evaluate the effectiveness and safety of artificial ascites in reducing perioperative complications. The data used in this study were derived from historical medical records and did not involve direct intervention on patients; therefore, specific Institutional Review Board (IRB) approval was not required. This research strictly followed standards for data privacy and the anonymization of medical records to ensure the confidentiality and security of participant data.

Participants

Inclusion criteria

Inclusion criteria included women aged 18–50 years diagnosed with ovarian cysts requiring sclerotherapy, without coagulopathy or significant cardiovascular diseases, and with cysts measuring larger than 4 cm in diameter.

Exclusion criteria

Allergy to medications used in the treatment.

Pregnant or breastfeeding women.

Patients with suspicious signs of malignant transformation in their cysts based on ultrasound or other imaging studies.

Preoperative evaluation of malignancy risk was performed using the Risk of Malignancy Index (RMI) score, which includes serum CA-125 levels, menopausal status, and ultrasound findings. Patients with high RMI scores suggestive of malignancy were excluded from the study.

Grouping and Treatment

Patients were randomly divided via electronic medical records into two groups:

Observation group (44 cases): Received sclerotherapy with artificial ascites.

The sclerotherapy procedure was performed under local anesthesia using an ultrasound-guided transabdominal approach. An 18-gauge PTC needle was used for the puncture, allowing precise aspiration of the cyst fluid and subsequent injection of sclerosing agents. Under ultrasound guidance, the puncture path was determined, and 300–500 ml of physiological saline solution was injected into the pelvic cavity to create a safety buffer zone(Fig. 1, Fig. 2). A puncture needle was then precisely inserted into the cyst under ultrasound guidance, and the cyst fluid was aspirated. The cyst cavity was repeatedly flushed with physiological saline until the cyst fluid became clear. The cyst was then flushed 6–8 times with 95% medical ethanol, and finally, 10 ml of polidocanol injection was retained in the cyst cavity as a sclerosing agent.

Control group (56 cases): Underwent standard sclerotherapy without artificial ascites.

Outcome Measures

Primary outcome measures included the incidence of pain and vagal reflex assessed during and within 24 hours post-operation, and the success rate of sclerotherapy evaluated by ultrasound at 3, 6, and 12 months post-treatment to determine treatment efficacy. Pain levels were measured using the Visual Analog Scale (VAS), where patients rated their pain on a scale from 0 (no pain) to 10 (worst possible pain). The incidence of vagal reflex was documented based on clinical symptoms such as bradycardia, hypotension, and syncope observed during the procedure.

Sclerotherapy Efficacy Criteria

Cured: Complete cyst disappearance, cyst reduction rate > 90%, and clinical symptoms disappear.

Significant Effect: Cyst reduction rate 51% − 90%, and clinical symptoms disappear.

Generally Effective: Cyst reduction rate ≤ 50%, and clinical symptoms relieved.

Ineffective: No cyst reduction or cyst enlargement, and no improvement in clinical symptoms.

Statistical analysis

Descriptive statistics (mean ± SD for continuous variables, percentages for categorical variables), independent t-tests for continuous variables, chi-square or Fisher's exact tests for categorical data, and logistic regression for multivariate analysis if initial tests showed significant differences. Statistical significance was set at P < 0.05, and all analyses were performed using SPSS 22.0.

In this study, 100 patients with ovarian cysts were enrolled, divided into the observation group (44 cases) and the control group (56 cases) based on whether artificial ascites was used (Table 1).

Table 1

Comparative Analysis of Treatment Outcomes Between Observation and Control Groups
Indicator	Observation Group (%)	Control Group (%)	P-value	Description
Age (mean ± SD)	32.1 ± 5.3	31.8 ± 5.6	0.78	Comparable age between groups
BMI (mean ± SD)	24.5 ± 3.1	24.2 ± 3.3	0.68	Comparable BMI between groups
Endometriosis-related	75	72.3	0.75	Higher distribution of endometriosis-related cysts
Non-endometriosis-related	25	27.7	0.75	Lower distribution of non-endometriosis-related cysts
Pain Incidence	11.36	35.71	< 0.01	Lower pain incidence indicates better pain management
Vagal Reflex Incidence	4.55	25	< 0.01	Significant reduction in vagal reflex incidence with artificial ascites
Nausea Incidence	4.5	20	< 0.01	Significant reduction in nausea incidence with artificial ascites
Infection Rate	0	0	> 0.05	No post-operative infections in either group
Cure Rate	93.18	82.14	< 0.05	Higher cure rate in observation group
Effective Rate	100	91.07	< 0.05	Higher effective rate in observation group

The observation group had significantly lower incidences of pain (11.36% vs. 35.71%, P < 0.01) and vagal reflexes (4.55% vs. 25.00%, P < 0.01) compared to the control group, highlighting the benefits of artificial ascites in reducing procedural discomfort (Fig. 3).

VAS Scores Comparison

The mean VAS score in the observation group was significantly lower (2.3 ± 0.8) than in the control group (5.2 ± 1.1) (P < 0.01), indicating that artificial ascites can significantly reduce procedural pain (Fig. 4).

Table 2

Sclerotherapy Efficacy Comparison Between Groups
Indicator	Observation Group (N = 44)	Control Group (N = 56)	P-value
Cured	41 (93.18%)	46 (82.14%)	< 0.05
Significant Effect	2 (4.55%)	3 (5.36%)	> 0.05
Generally Effective	1 (2.27%)	2 (3.57%)	> 0.05
Ineffective	0 (0.0%)	5 (8.93%)	< 0.05

Our study demonstrated that artificial ascites significantly reduced pain and vagal reflex incidence during ultrasound-guided percutaneous sclerotherapy for ovarian cysts. This finding aligns with previous studies highlighting the benefits of creating a physical separation between the target area and surrounding tissues to minimize complications[15]. The high success rate of sclerotherapy in both groups confirms the efficacy of this minimally invasive technique. However, the observation group, which utilized artificial ascites, showed a higher cure rate and effective rate, suggesting that artificial ascites may enhance the effectiveness of sclerotherapy. The reduced pain incidence and severity, along with the lower rate of vagal reflexes in the observation group, likely contributed to more complete and successful treatments. Pain and vagal reflexes can lead to incomplete or failed procedures; by minimizing these complications, artificial ascites ensures smoother and more effective sclerotherapy.

Effectiveness in Pain Reduction

The significant reduction in VAS scores in the observation group compared to the control group (2.3 vs. 5.2, P < 0.01) supports the notion that artificial ascites can mitigate pain during and after sclerotherapy. The most probable mechanism is that the physiological saline solution rapidly dilutes the sclerosing agent that leaks from the puncture site, thereby reducing its irritative symptoms and minimizing direct tissue irritation and mechanical stimulation. This aligns with previous findings by Meng et al. who observed similar reductions in pain incidence using this technique[15, 19, 20]. A similar reduction in procedural pain has been observed in artificial ascites-assisted radiofrequency ablation (RFA) for hepatic tumors[18]. The use of artificial ascites provided a safer distance between the liver and adjacent organs, thereby minimizing collateral damage during RFA and reducing postoperative pain[21–23, 20].

Nausea and Infection Rates

The incidence of nausea was recorded as a symptom often accompanying vagal reflex. In our study, patients who experienced vagal reflex also reported nausea. The observation group had a significantly lower incidence of nausea compared to the control group, consistent with the reduced vagal reflex incidence. Additionally, our study found that the post-operative infection rate was 0% in both groups, indicating that the use of artificial ascites does not increase the risk of infection.

Effectiveness in Sclerotherapy Efficacy

The efficacy comparison between the observation and control groups at 3, 6, and 12 months post-treatment showed that both groups had high cure rates (93.18% in the observation group vs. 82.14% in the control group, P < 0.05). The effective rate was also higher in the observation group (100%) compared to the control group (91.07%, P < 0.05). The significant difference in effective rates indicates that the artificial ascites technique likely improves sclerotherapy efficacy by providing a safer puncture path and reducing sclerosing agent leakage into surrounding tissues. Meng et al. reported that the use of artificial ascites led to better visualization during puncture and fewer complications [15].

Reduction of Vagal Reflex Incidence

The significant reduction in the incidence of vagal reflex in the observation group suggests that artificial ascites helps to minimize the direct stimulation of the vagus nerve during the procedure. One key mechanism is that the physiological saline solution rapidly dilutes the sclerosing agent that may leak from the puncture site, thereby reducing its irritative symptoms and minimizing direct tissue irritation. This rapid dilution of the sclerosing agent not only mitigates its immediate irritant effects but also prevents the diffusion of the agent to nearby sensitive structures, such as nerves, which could otherwise trigger a vagal reflex. The physical separation created by the artificial ascites also contributes to this protective effect by providing a buffer zone that further minimizes the risk of inadvertent nerve stimulation.

Sclerosing Agent Mechanism

Both 95% medical ethanol and polidocanol work as sclerosing agents by denaturing the cellular proteins of the cyst wall, impairing its fluid secretion function. This results in sterile inflammation within the cyst cavity, leading to subsequent collapse, atrophy, adhesion, and closure of the cyst wall, which is then absorbed by the body. The chemical action causes the cyst wall cells' proteins to coagulate and degenerate, impairing their ability to secrete fluids. Consequently, sterile inflammation occurs within the cyst cavity, leading to subsequent collapse, atrophy, adhesion, and closure of the cyst wall, which is then absorbed by the body[24–28]. T Thus, this mechanism provides a clear pathophysiological basis for the reduction of ovarian cysts through sclerotherapy.

Clinical Implications

Given the findings of this study, artificial ascites offers a practical and safe method to improve procedural comfort and efficacy during ultrasound-guided sclerotherapy. This is particularly useful in cases where cysts are located deep within the pelvis or near vital organs, as these situations increase the risk of accidental damage and complications. Moreover, its application can be extended to other minimally invasive abdominal procedures to further enhance patient safety and procedural success.

Artificial ascites has potential applications beyond ovarian cyst sclerotherapy. It has been increasingly used in ultrasound-guided ablation treatments for uterine fibroids and adenomyosis. In these procedures, artificial ascites helps to create a clear separation between the target tissue and surrounding organs, such as the bowel and bladder, thereby minimizing the risk of thermal injury to these structures. This technique not only improves the safety of the procedure but also enhances the precision of the ablation.

Limitations and Future Directions

While encouraging, the retrospective design and the moderate sample size of this study may limit the generalizability of the findings. Future research should include prospective randomized controlled trials to validate the effectiveness of artificial ascites across a broader demographic and explore its potential applications in other minimally invasive abdominal surgeries, such as liver or pancreatic interventions. Additionally, studies should aim to standardize the optimal volume of artificial ascites to maximize safety and efficacy.

Furthermore, the physical isolation mechanism of artificial ascites has proven applications in thermal ablation treatments for thyroid nodules and breast nodules, where it is commonly used to protect surrounding tissues by creating a buffer zone with injected fluids. This technique's efficacy in reducing thermal damage to non-target tissues during ablation has been well-documented and is widely accepted in clinical practice[29–33]. However, the application of fluid injection to alleviate conditions caused by constrictive adhesions remains underexplored. Such techniques could potentially be used to relieve compression in conditions like stenosing tenosynovitis, adhesive fasciitis, and peripheral nerve compression caused by surrounding adhesions. These areas represent promising avenues for future research, focusing on developing methods to inject therapeutic fluids that can effectively reduce adhesion and improve mobility without surgery. Initial studies could explore the feasibility, safety, and efficacy of this approach, potentially leading to novel treatments for a range of compressive syndromes.

Future Directions

Future investigations should aim to expand on these findings by exploring the impact of artificial ascites on different types and sizes of ovarian cysts and potentially extending its use to other surgical contexts to further enhance patient safety and procedural success[34].

This study conclusively demonstrates that ultrasound-guided artificial ascites-assisted puncture and sclerotherapy significantly improve the safety and efficacy of treatment for ovarian cysts. The observation group showed a substantial reduction in the incidence of pain (11.36% vs. 35.71%, P < 0.01) and vagal reflexes (4.55% vs. 25.00%, P < 0.01) compared to the control group. Additionally, the cure rate in the observation group was significantly higher (93.18% vs. 82.14%, P < 0.05), and the effective rate was also notably higher (100% vs. 91.07%, P < 0.05). The observation group also experienced a significantly lower incidence of nausea (4.50% vs. 20.00%, P < 0.01), with no post-operative infections in either group.

Given its excellent safety profile and effectiveness, the application of artificial ascites in clinical practice is recommended, particularly for complex cases involving deep-seated or anatomically challenging cysts. This technique can also be explored for other minimally invasive abdominal interventions to further enhance patient safety and procedural success.

VAS

Visual Analog Scale

IRB

Institutional Review Board

PTC

Percutaneous Transhepatic Cholangiography

RMI

Risk of Malignancy Index

BMI

Body Mass Index

RFA

Radiofrequency Ablation

Funding: This research was supported by the Jiaxing Public Welfare Research Plan (Grant No. 2019AY32014).

Conflict of Interest: The authors declare that they have no competing interests.

Ethical Approval: This study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of Zhejiang Rongjun Hospital.

Acknowledgements

The authors would like to express their gratitude to the Jiaxing Public Welfare Research Plan for their financial support of this study (Grant No. 2019AY32014). This funding has significantly contributed to the successful completion of the research presented in this paper.

Authors' Contributions

All authors participated in the design of the study and/or patient enrolment and met the criteria for authorship. Bin Meng and Mingmin Xu contributed to the study design, study conduct and supervision, scientific overview, data analysis, and manuscript editing. Bin Meng was directly involved in the clinical diagnosis of the patients, collected and analyzed the clinical data of the subjects, analyzed the data, and drafted the original manuscript. Xiaotao Wang and Qian Li were involved in the data curation, formal analysis, and investigation. Xiaotao Wang and Qian Li also contributed to the resources and project administration. The manuscript has been substantially revised by Bin Meng and Mingmin Xu. All authors read and approved the final manuscript.

Availability of Data and Materials

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request. The data used in this study were derived from historical medical records at Zhejiang Rongjun Hospital and all personal identifiers have been removed to ensure patient confidentiality.

Ethics Approval and Consent to Participate

This study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of Zhejiang Rongjun Hospital. Informed consent was obtained from all participants.

Consent for Publication

Not applicable.

Author Details

1 Department of Interventional Ultrasound, Zhejiang Rongjun Hospital, Jiaxing, China

Competing Interests

The authors declare that they have no competing interests.

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No competing interests reported.

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You are reading this latest preprint version

Safety and Effectiveness of Ultrasound-Guided Artificial Ascites-Assisted Puncture and Sclerotherapy for Ovarian Cysts

Status:

Version 1

Abstract

Background

Methods

Results

Conclusion

Figures

Background

methods

Study Design

Participants

Inclusion criteria

Exclusion criteria

Grouping and Treatment

Outcome Measures

Sclerotherapy Efficacy Criteria

Statistical analysis

Results

VAS Scores Comparison

Discussion

Effectiveness in Pain Reduction

Nausea and Infection Rates

Effectiveness in Sclerotherapy Efficacy

Reduction of Vagal Reflex Incidence

Sclerosing Agent Mechanism

Clinical Implications

Limitations and Future Directions

Future Directions

Conclusions

Abbreviations

Declarations

References

Additional Declarations

Status:

Version 1