A nomogram predicts the risk factors for bleeding connected with biliary stent placement therapy

doi:10.21203/rs.3.rs-4919284/v1

Background: Clinically, the ability to predict intra-and postoperative bleeding during stent placement is limited, particularly in patients with high-risk bleeding factors or coagulation disorders. The aim of this study was to create a nomogram to predict bleeding from stent implantation.

Methods: Medical records were collected on March 25, 2024, for 590 cases.

Logistic regression was used to construct the nomogram, and variable screening was performed through LASSO regression. The area under the curve (AUC) was calculated to determine the discriminative capacity of each model. A calibration curve was used to evaluate the prediction accuracy of the model, and the consistency index (CI) was used to determine the performance of the model. Clinical effectiveness was assessed through the use of decision curve analysis (DCA).

Results：LASSO regression identified four clinical features of patients, which were used to generate a nomogram. The AUC was 0.816 (95% CI, 0.743-0.889) in the training model and 0.804 (95% CI, 0.691-0.916) in the test set model. The proposed nomogram would yield a net gain in forecasting stent insertion bleeding if the threshold likelihood of bleeding fell between 0 and 0.8, as demonstrated by a well-calibrated predictive model and DCA.

Conclusions: Four clinical traits of patients who underwent stent placement were combined to create a nomogram predicting risk of bleeding.

Biological sciences/Cancer

Health sciences/Oncology

Health sciences/Risk factors

Biliary Stent

Prediction

Bleeding

Bile is a liquid composed of bile salts, bilirubin, and cholesterol, which are necessary in fat metabolism; bile is produced in the liver and sent through the bile ducts to the intestines. Bile produced in the liver transits through the right and left hepatic ducts to the common hepatic duct, where it merges with the cystic duct to form the common bile duct, which connects with the pancreatic duct in the head of the pancreas before entering the intestine through the opening of the duodenal papilla. Biliary obstruction is a blockage of the biliary system that causes a decrease in bile flow from the liver to the intestines. Biliary blockage can develop at any point in this system and may result in severe problems, such as liver dysfunction, renal failure, nutritional deficits, coagulation issues, and infections[^1]. Most bile moves through the cystic duct to the gallbladder where it is concentrated and temporarily stored, while the remainder flows through the common bile duct to the duodenum. Gallbladder contraction and relaxation of the Oddi’s sphincter are regulated by hormones.

Biliary obstruction can be classified as intrahepatic or extrahepatic; intrahepatic obstruction is commonly known as cholestasis (not a focus of this study). Biliary obstructions are also categorized as benign or malignant. Benign conditions encompass various issues, such as choledochal stones (primary and secondary), choledochal cysts, choledochal dilatation, Mirizzi's syndrome, benign structural disorders such as primary sclerosing cholangitis (PSC), fibrotic strictures from gallstone passages, or medically-induced strictures from biliary intubation. Additional reasons for benign biliary obstruction include cholangiopathies caused by parasites, such as Treponema pallidum and Ascaris lumbricoides, which lead to the blockage of intrahepatic or extrahepatic bile flow, as well as inflammatory and autoimmune conditions, such as AIDS cholangiopathy and autoimmune cholangiopathy.[^2]

Malignant bile duct obstruction (MBO) can result from many primary cancers, including cholangiocarcinoma, juxtaglomerular carcinoma, gallbladder carcinoma, pancreatic carcinoma, hepatocellular carcinoma, and metastatic illness[^3][4][5]. Many cases of MBO are unsuitable for surgery and do not respond well to external-beam radiotherapy or chemotherapy; consequently, biliary stenting has gained popularity as a less intrusive and more comfortable alternative to surgery[^6].

Endoscopic retrograde cholangiopancreatography (ERCP) is the predominant technique used to diagnose and treat primary pancreaticobiliary conditions and manage postoperative issues, and it is deemed a secure surgery[^7]. Nevertheless, it can have severe consequences[^8], with the typical adverse effects of ERCP being pancreatitis, perforation, cholangitis, and bleeding. The prevalence of stent-related problems is increasing, owing to the growing use of ERCP for treating pancreatobiliary system illnesses[^9]. Intraoperative bleeding can obstruct the surgical field and complicate the procedure, whereas delayed bleeding may extend the patient's hospital stay and even result in life-threatening complications. This study address the need to visually assess—through the use of a nomogram—the risk factors of bleeding in patients undergoing ERCP with stent implantation.

The patient population is the same as that described in a previous study: 590 patients underwent ERCP with biliary stent implantation between June 2021 and December 2023 (Fig. 1). Bleeding from stenting is characterized by intraoperative bleeding that necessitates electrocoagulation, hemostatic clips, or epinephrine spray to control bleeding; bleeding occurring after stenting; or postoperative symptoms, such as vomiting, black stools, drainage of bloody material, or a postoperative decrease in hemoglobin levels exceeding 20 g/L[^10]. Bleeding can occur either during the operation or in a delayed fashion, typically approximately 10–14 days after surgery [^11]. Ethical approval for the study was obtained from the hospital and patient information was kept anonymous.

Inclusion and exclusion criteria:

The inclusion criteria were: 1) hospitalized patients, 2) aged over 18 years; 3) patient gave consent for stent placement, 4) ceased antiplatelet and anticoagulant medications 5-7 days before stent placement and resumed medication 3 days post-procedure, 5) procedure performed by a qualified and experienced physician, and 6) complete case information and data

The exclusion criteria were: 1) incomplete stenting, 2) incomplete medical records, 3) lack of follow-up, 4) preoperative gastrointestinal bleeding and bleeding from non-stenting procedures, 5) post-stenting perforation, 6) patients not admitted for initial stenting or stent replacement, 7) mortality during admission, 8) patients who underwent biliary-intestinal anastomotic stenting.

The clinical characteristics analyzed in this study were: age, sex, smoking, drinking. Clinical indications were: benign, duodenal cancer, pancreatic head cancer, ampullary cancer, gallbladder cancer, biliary duct cancer, liver cancer. Background diseases were：hypertension, diabetes, hyperlipemia, CHD, papillary diverticulum, liver cirrhosis, calculus of bile duct, diameter＞1cm, renal-failure. Essential operational factors: EST, balloon dilatation, basket extraction, lithotripsy, spyglass examination, ENBD, gallbladder wall thickening, stent type, and amount＞1. Patient's medical background includes cholecystectomy, subtotal gastrectomy, and use of anticoagulant medicine；Laboratory test results and pertinent data:p-WBC, p-PLT, p-HB, p-LYMPH, p-MONO, p-NEUT, p-ALT, p-AST, p-TBIL, p-DBIL, p-IBIL, p-γ-GT, p-ALP, p-ALB, p-BUN, p-SCR, a-WBC, a-PLT, a-HB, a-LYMPH a-MONO,a-NEUT, a-ALT, a-AST, a-TBIL, a-DBIL, a-IBIL, a-γ-GT, a-ALP, a-ALB, a-BUN, a-SCR, FIB, PT-INR, PT, APTT, and TT.

Ethical issues

Ethical clearance was obtained from Tianjin Third Central Hospital and Medicine Ethical Review board (IRB).Due to the retrospective nature of the study, the Ethics Committee of Tianjin Third Central Hospital waived the need to obtain informed consent.The retrospective study complied with the ethical principles of the Declaration of Helsinki and the Measures for Ethical Review of Biomedical Research Involving Human Beings. Informed immunity was obtained as this study only utilized pre-existing medical records or data, did not involve the identity or privacy of the subjects, did not pose any risk or harm to the subjects, and the data were anonymized when analyzed.

Statistical analysis

Categorical data are represented by frequencies and percentages, whereas continuous variables are represented by means of a normal distribution and median quartiles for a non-normal distribution. ROC curves were generated for all variables (Fig. 2) and a significance test for correlation (level=0.95) was conducted to calculate AUC values (Fig. 3). A heat map was created using the correlation coefficients (Fig. 4) to visualize variables with significant covariance or correlation and to identify the most appropriate variables for logistic regression. Data dimensions and predictors were selected using the LASSO regression technique (Fig. 5) to eliminate "suspected risk factors.” The dataset was randomly divided into a training set (n=354) and a test set (n=236) in a 6:4 ratio. A multifactorial logistic regression analysis was conducted on the identified "suspected risk factors" to create a nomogram of bleeding risk factors (Fig. 6).

During model validation, we employed a bootstrap approach for internal validation using 1,000 samples of the raw data. The consistency index (CI) and 95% confidence intervals were used to assess the discriminatory ability of the predictive model. The predictive power of the model was assessed using the area under the curve (AUC) of the participants’ characteristics (ROC). An AUC value greater than 0.75 suggests that the model has sufficient discriminatory ability. The accuracy of the model was confirmed using the calibration curves. A decision curve analysis (DCA) was performed to examine net patient benefit. The proposed nomogram would yield a net gain in forecasting stent insertion bleeding if the threshold likelihood of bleeding fell between 0 and 0.8, as demonstrated by the well-calibrated predictive model and DCA(Fig. 8).

R software (version 4.3.2; R Foundation for Statistical Computing, Vienna, Austria) was used, and P < 0.05 was considered statistically significant. The following R packages were used：(corrplot), (glmnet), (caret), (CBCgrps), (nortest), (tidyverse), (ggpubr), (rms), and (pROC). SPSS software (version 27.0) was also used in the statistical analysis.

Upon analyzing data from the patients' hospital records, it was found that 11.5% (68 out of 590) of the patients experienced bleeding following stent implantation. We present in Table 1 the demographic and clinical characteristics of the study participants. ROC curves were generated for 72 variables, and the area under the curve was calculated. The top three AUC values were for spyglass examination, cholangiocarcinoma, and FIB. There was a strong link between bilirubin levels, blood cell counts, urea nitrogen, creatinine, and coagulation levels before and after surgery, as shown in Figure 4. Consequently, there was a notable issue of multicollinearity among the independent variables in the dataset containing the preoperative and postoperative clinical characteristics of the patients.

Seven variables were selected based on the nonzero coefficients derived from the LASSO regression analysis (Fig. 5). The variables included were benign cancer, ampullary cancer, cholangiocarcinoma, EST, spyglass examination, narrowed bile duct , and FIB. Multifactorial logistic regression analysis (Table 2) was conducted on the seven variables to create a predictive model for the bleeding risk from stent placement. Four independent risk factors (P <0.2) were identified: benign, EST, spyglass, and narrowed bile duct.

The AUC for the training set model (n=354) was 0.816 (95% CI, 0.743-0.889) and that for the test set model(n=236) was 0.804 (95% CI, 0.691-916) in a study on Bleeding Prediction Models. Calibration curves of the model were generated by applying the bootstrap approach with putback resampling 1,000 times, as shown in Figure 7, c and d. The x axis in the calibration curve represents the predicted bleeding probability of the model, whereas the y axis represents the actual bleeding probability. The dotted line indicates a perfect prediction model and the solid line represents the prediction ability of the model in this study. The accuracy of the model can be determined by the distance between the two lines on the curve, indicating a higher level of accuracy in this model. DCA was utilized to assess the overall advantage to patients resulting from the clinical choices informed by the LASSO model (Fig. 7d). These findings indicate that utilizing a LASSO regression model to support clinical decision-making provides a positive outcome for patients when the probability threshold ranges from 0 to 0.8. We created a nomogram to showcase the predictive model, offering a tailored tool for estimating the likelihood of bleeding during stent implantation.

Complications after ERCP with stent bleeding are primarily due to endoscopic sphincterotomy (EST), recurrent frictional movement of the stent against the biliary lining, and lesions of the biliary lining. The European Society of Gastrointestinal Endoscopy (ESGE) advises against performing routine endoscopic biliary sphincterotomy before inserting a single plastic stent or an uncovered or partially covered self-expanding metal stent to alleviate biliary blockage. The incidence of gastrointestinal bleeding following ERCP is approximately 1.3%, with the majority of cases being mild-to-severe. EST is the primary cause and has been identified as a significant risk factor of post-ERCP bleeding, which is consistent with our statistical findings. As a temporary fix for bleeding after sphincterotomy that does not stop with normal hemostasis, the ESGE recommends the use of self-expanding metal stents that cover the entire biliary system.

A meta-analysis of six trials with 5,526 individuals and a recent retrospective study with a matched cohort of 331 patients[^12] identified cirrhosis as a risk factor for bleeding following sphincterotomy. Four controlled studies examined the association between end-stage renal disease dialysis and primary sclerosing biliary cholangitis (PSB) with 7,508 cases and 45,026 controls (OR 1.4,95%, CI 1.2-1.6)[^{13][14][15][16]}. It has been verified that individuals with end-stage renal illness who need dialysis are at a higher risk of postoperative hemorrhage, particularly within the first year of hemodialysis[^17], and that these hemorrhagic events are more severe compared to those without kidney disease^[⁸^]. Endoscopic balloon dilatation (8.7%) and sphincterotomy (8.3%) were also performed at equal rates.[^18] Two meta-analyses, including six and seven randomized controlled trials with 966 and 999 patients, respectively, found that early precision sphincterotomy for challenging biliary access did not increase the risk of post-ERCP bleeding compared to continuous intubation attempts.[^19][20][21] Rare consequences of biliary stent installation include cholecystitis, intestinal perforation, pancreatitis, and stent fracture.[^22][23][24]Bleeding caused by lesions in the biliary tract is primarily associated with the lesion type and severity. Malignant strictures are more prone to bleeding than biliary strictures caused by benign tumors, as demonstrated in this study. MBO can result from several original malignancies such as cholangiocarcinoma, jugular carcinoma, gallbladder carcinoma, pancreatic carcinoma, and metastatic illness.^[1][2][3]Patients with early malignant biliary obstruction may undergo radical surgical resection as a potential curative treatment. Most patients with MBO are diagnosed in the late stages because of the absence of specific signs and symptoms.[^25] [^26]Biliary stenting is the primary treatment for unresectable malignant biliary obstruction. It helps alleviate cholestasis and obstructive jaundice, enhances liver function, and improves the quality of life.[^27] [^28][29]In general, malignant biliary occlusions are more prone to bleeding compared to benign lesions, perhaps due to artery wall necrosis produced by tumor-induced pressure. Anatomical differences may indicate various mechanisms causing arterial bleeding.[^30] The right hepatic artery is typically located along the edge of a self-expanding metallic stent (SEMS), and is at risk of harm if the stent penetrates the bile duct wall. Hemorrhage of the gastroduodenal artery or its branches may occur due to the close proximity of the SEMS to the proximal-central region. Animal studies by Carrasco et al.[^31] showed that chronic inflammation and fibrosis of the submucosal layer happened after a metallic stent was put in place, and the severity increased with the length of time the stent was in place. Tsuji et al. found that the use of a metallic stent and external irradiation together led to higher levels of chronic inflammation and fibrosis in the submucosa[^32]. Hyun et al.[^33] reported instances of delayed arterial bleeding manifested as pseudoaneurysms within or in close proximity to the stent mesh. A tumor around the bile ducts in the stent, inflammation around the bile ducts, adhesion between the metal stent and the artery, and a history of radiation therapy may all work together to create a pseudoaneurysm, which leads to delayed arterial bleeding. Transcatheter arterial embolization (TAE) is the preferred treatment for arterial pseudoaneurysms or arterio-biliary fistulas[^34][35][36]. Studies have shown that TAE has technical and clinical success rates of 100% and 94.7%, respectively, for the treatment of arterial hemorrhage associated with delayed SEMS placement, suggesting that it is an effective therapeutic option. Radiofrequency ablation (RFA) or photodynamic therapy (PDT) combined with biliary stenting is currently the standard treatment for patients with unresectable MBO[^37][38]. Network rankings indicate that RFA+ stenting has the highest risk of bleeding, whereas PDT+ stenting is considered the safest option[^39].

Choledochoscopy is mostly used to assess uncertain biliary strictures and to perform intraductal lithotripsy of large or obstructive stones. Additional uses include intraductal pancreatic lithotripsy, evaluation of intraductal papillary mucinous neoplasms (IPMNs) in the main ducts, staging of peripapillary and cholangiocarcinoma, and determination of the extent of intraductal dilatation. Cholangioscopy can be used to diagnose Mirizzi syndrome, assess biliary hemorrhage and unexplained biliary filling deficiencies, reposition biliary or pancreatic stents, place guidewires, drain the gallbladder using a transapical approach, perform intraductal ablation therapy, and manage primary sclerosing cholangitis[^40][41]. An analysis of 45 studies of cholangioscopy revealed a 7% occurrence of adverse events (AEs), such as pancreatitis (2%), cholangitis (4%), and perforation (1%). Spyglass-associated bleeding is uncommon and is linked to developmental abnormalities in the biliary and fragile tumor vasculature. Bokemeyer et al. [^42]found that 83.3% of the patients had no adverse events after digital SOC-assisted guidewire placement. Nevertheless, complications such as post-interventional pancreatitis and cholangitis were observed in 16.7% of all cholangioscopies, with each occurring in two cases (6.7% each). In addition, a single episode of serious bleeding necessitated endoscopic intervention (3.3%). Patients with benign stenosis had a decreased rate of complications after digital SOC compared with patients with malignant stenosis (11.8% vs. 23.1%; p = 0.63).

Endovascular methods are rarely used to treat bleeding during ERCP and endoscopic sphincterotomy. Most of these issues are mild or moderate and can be effectively handled by endoscopists. [^43]If significant or uncontrolled bleeding occurs and cannot be managed locally using endoscopic procedures, endovascular intervention is the preferred treatment. A study by So et al.[^44] reported successful hemostasis in 10 patients with significant bleeding following ERCP and sphincterotomy with embolization of 12 arterial branches. In summary, ERCP and stent implantation may lead to significant biliary and gastrointestinal bleeding, and should be considered in the differential diagnosis of post-ERCP bleeding after ruling out sphincterotomy-related bleeding. Timely diagnosis and action are crucial for success, and can help prevent life-threatening consequences.

Foreign studies have found that the length of the biliary stricture may affect the efficiency of biliary stenting, although this relationship was not statistically significant[^45]. Some local studies have indicated that biliary stenosis with longer and more extensive lesions may lead to tumor growth, passing through the stent mesh or extending beyond its edge, resulting in reduced therapeutic efficacy[^46]. This study found that the length of the biliary stenosis was an independent risk factor for stenting effectiveness (P=0.047). This may be because a longer biliary stenosis makes stent placement and unblocking via ERCP more challenging, leading to increased friction and extrusion against the biliary wall of the stenotic segment.

In this study, a prediction nomogram for bleeding risk was developed using four clinical parameters in patients who underwent ERCP with stenting. This could improve the evaluation of the risks associated with stenting procedures in individuals with concomitant coagulation disorders or high-risk bleeding factors. The disadvantage is that the number of patients included in this study was not large, and no external verification was performed, which is also the direction of our efforts.

Statement:All data generated or analysed during this study are included in this published article [and its supplementary information files].

Disclose:

Mr. Di He , Mr.Hechen Shen,Mr.Weihua Yin and Prof. Guiming Shu have no conflicts of interest to disclose.

Declaration competing interest

The authors declare that there are no potential financial or nonfinancial conflicts of interest.

Acknowledgments

Not available.

Author Contributions

Conceptualization, Di He ,Hechen Shen and Weihua Yin ; writing and correcting after review,Di He and Guiming Shu . All authors have read and agreed to the published version of the manuscript.

Funding

This work was supported by the Tianjin Medical Key Discipline Construction Project (TJYXZDXK-034A).

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Table 1 Demographic and clinical characteristics of study participants

Variables	Total (n = 590)	0 (n = 522)	1 (n = 68)	p
Sex, n (%)				0.306
Female	231 (39)	200 (38)	31 (46)
Male	359 (61)	322 (62)	37 (54)
Smoking, n (%)				0.462
No	362 (61)	317 (61)	45 (66)
Yes	228 (39)	205 (39)	23 (34)
Drinking, n (%)				0.318
NO	398 (67)	348 (67)	50 (74)
YES	192 (33)	174 (33)	18 (26)
Benign, n (%)				< 0.001
NO	415 (70)	355 (68)	60 (88)
YES	175 (30)	167 (32)	8 (12)
Duodenal carcinoma, n (%)				0.522
NO	584 (99)	517 (99)	67 (99)
YES	6 (1)	5 (1)	1 (1)
Pancreatic head carcinoma, n (%)				0.025
NO	442 (75)	383 (73)	59 (87)
YES	148 (25)	139 (27)	9 (13)
Ampullary cancer, n (%)				0.162
NO	542 (92)	483 (93)	59 (87)
YES	48 (8)	39 (7)	9 (13)
Gallbladder carcinoma, n (%)				1
NO	568 (96)	502 (96)	66 (97)
YES	22 (4)	20 (4)	2 (3)
Biliary duct carcinoma, n (%)				< 0.001
NO	433 (73)	398 (76)	35 (51)
YES	157 (27)	124 (24)	33 (49)
Liver carcinoma, n (%)				0.142
NO	560 (95)	498 (95)	62 (91)
YES	30 (5)	24 (5)	6 (9)
Hypertension, n (%)				0.468
NO	315 (53)	282 (54)	33 (49)
YES	275 (47)	240 (46)	35 (51)
Diabetes, n (%)				0.321
NO	433 (73)	387 (74)	46 (68)
YES	157 (27)	135 (26)	22 (32)
Hyperlipemia, n (%)				1
NO	567 (96)	501 (96)	66 (97)
YES	23 (4)	21 (4)	2 (3)
CHD^[1], n (%)				1
NO	497 (84)	440 (84)	57 (84)
YES	93 (16)	82 (16)	11 (16)
Papillary diverticulum, n (%)				1
NO	507 (86)	449 (86)	58 (85)
YES	83 (14)	73 (14)	10 (15)
Liver cirrhosis, n (%)				0.195
NO	551 (93)	490 (94)	61 (90)
YES	39 (7)	32 (6)	7 (10)

Note: [1] CHD:coronary heart disease;

Table 2 Multifactor logistic analysis

Note: Coef: coefficient; S.E.: standard error; wald: chi-square value; Pr(>|Z|): p-value corresponding to the Z statistic

No competing interests reported.

data.xlsx

A nomogram predicts the risk factors for bleeding connected with biliary stent placement therapy

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Abstract

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Introduction

Materials and Methods

Ethical issues

Results

Discussion

Conclusion

Declarations

References

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Additional Declarations

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Status:

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