Analysis of risk factors for bile leakage after laparoscopic exploration and primary suture of common bile duct

Abstract

BACKGROUND

Bile leakage is a common complication following laparoscopic common bile duct exploration (LCBDE) with primary duct closure (PDC). Identifying and analyzing the risk factors associated with bile leakage is crucial for improving surgical outcomes.

AIM

To explore the value analysis of common risk factors for bile leakage after LCBDE and PDC, with a focus on strict adherence to indications.

METHODS

Clinical data of 106 cases undergoing LCBDE + PDC in the Hepatobiliary and Pancreatic Surgery Department (Division 1) of Chuzhou First People’s Hospital from April 2019 to March 2024 were collected. Retrospective and multiple factor regression analysis were conducted on common risk factors for bile leakage. The change in surgical time was analyzed using the cumulative summation (CUSUM) method, and the minimum number of cases required to complete the learning curve for PDC was obtained based on the proposed fitting curve by identifying the CUSUM maximum value.

RESULTS

Multifactor logistic regression analysis showed that fibrinous inflammation and direct bilirubin/indirect bilirubin were significant independent high-risk factors for postoperative bile leakage (P < 0.05). The time to drain removal and length of hospital stay in cases without bile leakage were significantly shorter than in cases with bile leakage (P < 0.05), with statistical significance. The CUSUM method indicated that a minimum of 51 cases were required for the surgeon to complete the learning curve (P = 0.023).

CONCLUSION

With a good assessment of duodenal papilla sphincter function, unobstructed bile-pancreatic duct convergence, exact stone clearance, and sufficient surgical experience to complete the learning curve, PDC remains the preferred method for bile duct closure and is worthy of clinical promotion.

Key Words: Laparoscopic common bile duct exploration; Primary duct closure; Bile leakage; Risk factor analysis; Cumulative summation

Core Tip: This study identifies key risk factors for bile leakage following laparoscopic common bile duct exploration and primary duct closure (PDC). Through retrospective analysis and logistic regression, fibrinous exudation and direct bilirubin/indirect bilirubin were found to be significant independent risk factors. The cumulative summation method demonstrated that a minimum of 51 cases is required for surgeons to master the PDC technique effectively. Proper assessment of duodenal papilla function, ensuring bile duct patency, and achieving surgical proficiency are essential for minimizing complications. Adhering to these guidelines may optimize patient outcomes and promote PDC as a preferred method in clinical practice.

INTRODUCTION

Laparoscopic common bile duct exploration (LCBDE) as a mature surgical method for treating intrahepatic and extrahepatic bile duct stones has undergone more than a century of development[1-4]. With the continuous advancement of medical technology, especially the use of high-definition laparoscopy, high-definition cholangioscopy, and stone fragmentation techniques, the minimally invasive and effectiveness of LCBDE have been significantly improved. In recent years, an increasing number of studies support the use of primary duct closure (PDC) rather than the traditional T-tube drainage (TTD) as the preferred method for bile duct repair after LCBDE, early literature indicates that although the first common bile duct exploration performed in 1889 used PDC for bile duct repair, TTD remains the primary method for duct repair after common bile duct exploration today, and PDC has not gained the widespread application initially expected[5-7]. With advancements in high-definition laparoscopy, high-definition cholangioscopy, and stone fragmentation techniques, the minimally invasive nature and effectiveness of LCBDE have significantly improved. Research shows that PDC is superior to TTD in terms of safety and minimally invasive nature, with no significant difference in efficacy. However, the indications and contraindications for PDC are not clearly defined. Despite PDC becoming a routine procedure in large hepatobiliary surgical centers, its global adoption rate remains low, mainly due to concerns among doctors and patients about potential complications after PDC[8,9]. However, despite PDC becoming a routine procedure in large hepatobiliary surgical centers, its adoption rate in broader medical practice remains low. This is mainly due to concerns among doctors and patients about potential complications such as bile leakage and bile duct strictures after PDC.

This study aims to explore how, under strict control of surgical indications, analyzing known risk factors for bile leakage after PDC can further optimize surgical strategies and reduce the incidence of complications. The research will summarize and analyze factors that may lead to bile leakage after PDC, including but not limited to patient age, bile duct diameter, severity of cholangitis, bile duct injury during surgery, and postoperative bile duct pressure. The role of multidisciplinary team collaboration, including surgeons, anesthesiologists, nursing teams, and radiologists, is increasingly recognized in improving the success rate of PDC. The exact risk factors for bile leakage after PDC are not yet fully understood. This study aims to explore how, under strict control of surgical indications, analyzing known risk factors for bile leakage after PDC can further optimize surgical strategies and reduce the incidence of complications. The research will also explore how collaboration among multidisciplinary teams, including surgeons, anesthesiologists, nursing teams, and radiologists, can improve the success rate of PDC. Furthermore, the study will evaluate the role of preoperative imaging studies in predicting the risk of bile leakage and the importance of intraoperative cholangiography in determining bile duct repair strategies.

MATERIALS AND METHODS

Study population

A total of 106 cases were included in this study, consisting of patients who underwent LCBDE + PDC for liver extrahepatic bile duct stones (or combined with gallstones) from January 2019 to April 2024 at the First People’s Hospital of Chuzhou City. Among them, there were 46 males (43.4%) and 60 females (56.6%). The comorbidities included: History of diabetes in 6 cases (5.66%), history of hypertension in 36 cases (33.96%), history of previous laparoscopic common surgery in 11 cases (10.38%), and history of acute pancreatitis in 3 cases (2.83%). Postoperatively, bile leakage occurred in 12 cases (11.32%), all of which were classified as grade 1 complications according to the Clavien-Dindo classification, and were managed with conservative observation leading to self-healing and discharge upon recovery. This study was approved by our hospital’s ethics committee. Patients and their families signed informed consent forms before the surgery.

Inclusion and exclusion criteria

Inclusion criteria: (1) Patients with common bile duct dilation or suspected common bile duct lesions with negative exploration results; (2) Patients who have had their common bile duct stones removed completely and the end of the common bile duct is unobstructed; (3) Patients with gallbladder stones, common bile duct stones, and distal obstruction or stenosis of the common bile duct all effectively treated during surgery; (4) After completing the first stage suture surgery, observe the absence of sustained obvious bile leakage at the incision site of the common bile duct; and (5) Those who have successfully retained nasobiliary drainage before or during surgery.

Exclusion criteria: (1) Residual stones in the extrahepatic bile duct and stenosis at the end of the common bile duct that were not treated or treated satisfactorily during surgery; (2) Intrahepatic bile duct stones combined with intrahepatic bile duct stenosis; (3) Long term, reliable, and unobstructed external drainage of the bile duct is required due to the primary disease; (4) Elderly patients with biliary and pancreatic duct diseases; and (5) Combine patients with severe cardiovascular and pulmonary diseases.

Surgical methods

Complete cholecystectomy according to standard laparoscopic common operating procedures; Fully expose the common bile duct (free descending duodenal bulb if necessary), use low-power electrocoagulation (30 W) to occlude the serosal vascular network of the anterior wall of the bile duct, and make a sharp longitudinal incision of about 0.6 cm of the anterior wall of the common bile duct (depending on the size of the stone); Complete cholangioscopy for stone removal, clear infectious fibrous exudate, fully evaluate the function and patency of the duodenal papilla, and ensure accurate stone removal; Adopt intermittent/continuous suture of bile duct incision (suture selection: 4-0 Vicryl suture); Take out the specimen, rinse the surgical area, observe and rule out bile leakage, and then place a drainage tube at the lesser omentum hole to fix it by pulling out a trocar 5 mm below the right rib margin. Under direct visualization, remove each trocar and suture the incision layer by layer. Postoperative management includes monitoring the abdominal drainage tube: Closely observe the volume and nature of bile drainage. If bile is continuously drained for 3 days postoperatively or the single-day drainage volume is ≥ 100 mL, bile leakage may be indicated. For patients without a drainage tube, monitor for signs of peritoneal irritation. If necessary, perform abdominal puncture to check for bile. Suspected bile leakage can be confirmed via intraoperative cholangiography. Prompt control of infections secondary to bile leakage is crucial to avoid contraindications for surgical treatment. Provide appropriate nutritional support to aid recovery. Criteria for determining bile leakage typically include: Continuous bile drainage from the abdominal tube for 3 days post-surgery or single-day drainage volume ≥ 100 mL. For those without a drainage tube, signs of peritoneal irritation, bile extracted via abdominal puncture, or intra-abdominal bile found during reoperation. Detection of contrast agent accumulation outside the biliary system through intraoperative cholangiography or postoperative imaging (e.g., computed tomography, magnetic resonance imaging) suggests bile leakage. Symptoms like fever, abdominal pain, and tenderness, along with laboratory findings (e.g., elevated white blood cell count), support the diagnosis of bile leakage.

Observation indicators and follow-up

Monitor postoperative drainage volume (mL/day) to determine the presence of bile leakage, surgical time, postoperative extubation time, postoperative discharge time, and total hospitalization costs. All cases were followed up routinely for 6-12 months after surgery, and no fluid accumulation, bile duct stenosis, stone recurrence.

Learning curve

Apply the cumulative summation (CUSUM) method to analyze the changes in surgical time. Representing the actual surgical time of each patient and the average surgical time of the same group of patients. Calculate the deviation between the actual surgical time value and the average surgical time value for each patient, and obtain CUSUM by summing multiple times. The calculation formula for this study is as follows: Sort the samples in the order of surgery and edit the serial numbers. Draw a scatter plot with CUSUM value as the vertical axis and number of cases as the horizontal axis, and then perform curve fitting. The fitting coefficient was used to determine the degree of fitting, and linear, quadratic, and cubic fitting were performed separately. The closer the value is to 1, the better the fitted curve.

Statistical analysis

This article uses SPSS 27.0 and R 4.3.2 to process and analyze the data. Continuous data is represented in the form of mean ± SD, while categorical data is represented in the form of frequency (percentage). Single factor logistic regression was used to analyze the risk factors for bile leakage, and multiple factor logistic regression was used to analyze the independent risk factors for bile leakage. The differences were statistically significant with P < 0.05 in the entire study. The rank sum test is used to analyze whether postoperative bile leakage has a significant impact on extubation time, discharge time, and total hospitalization costs. Construct a learning curve using CUSUM and fit it.

RESULTS

Using single factor logistic regression to screen risk factors

A single factor logistic regression model was established with total bilirubin, straight to straight ratio, history of diabetes, operation time, number of cases of surgery, history of hypertension, suture mode, incidence, common bile duct stones (single, multiple, discharged stones, fibrinous exudation, microstones), gallstones (microstones, multiple), grass to propylene ratio, albumin, white blood cell, total bile acid, hemoglobin, γ-glutamyl transpeptidase, C-reactive protein, common bile duct diameter, carbohydrate antigen 199, alkaline phosphatase, and other factors as independent variables, and whether bile leakage occurred after surgery as dependent variables (Tables 1 and 2). From the above results, it can be concluded that common bile duct stones (fibrinous exudation), total bilirubin, and direct bilirubin/indirect bilirubin ratio (direct to indirect ratio) have a significant impact on whether bile leakage occurs after surgery (P < 0.05), and are risk factors for postoperative bile leakage.

Table 1 Data summary and analysis, n (%).

Characteristic		Overall	No bile leakage occurs	Gallbladder leakage occurs
Gallstones-multiple	No	90 (84.91)	78 (100)	12 (100)
	Yes	16 (15.09)	16 (0)	0 (0)
Gallstones-micro stones	No	78 (73.58)	69 (75)	9 (75)
	Yes	28 (26.42)	25 (25)	3 (25)
Gallstones-post laparoscopic common surgery	No	93 (87.74)	86 (58.33)	7 (58.33)
	Yes	13 (12.26)	8 (41.67)	5 (41.67)
Common bile duct stones-single	No	67 (63.21)	60 (58.33)	7 (58.33)
	Yes	39 (36.79)	34 (41.67)	5 (41.67)
Common bile duct stones	No	52 (49.06)	47 (41.67)	5 (41.67)
	Yes	54 (50.94)	47 (58.33)	7 (58.33)
Common bile duct stones-micro stones	No	37 (34.91)	34 (36.17)	3 (25)
	Yes	69 (65.09)	60 (63.83)	9 (75)
Common bile duct stones-cellulose	No	72 (67.92)	69 (73.40)	3 (25)
	Yes	34 (32.08)	25 (26.60)	9 (75)
Common bile duct stones	No	103 (97.17)	91 (100)	12 (100)
	Yes	3 (2.83)	3 (0)	0 (0)
CBD	5-6	7 (6.6)	6 (8.33)	1 (8.33)
	6-7	17 (16.04)	15 (16.67)	2 (16.67)
	7-8	16 (15.09)	15 (8.33)	1 (8.33)
	8-9	18 (16.98)	15 (25)	3 (25)
	> 9	48 (45.28)	43 (41.67)	5 (41.67)
Factors, mean ± SD
WBC		7.35 ± 3.36	7.57 ± 3.39	5.64 ± 2.56
HB		132.1 ± 16.42	132.23 ± 17.15	131.08 ± 9.23
CRP		22.42 ± 46.68	23.91 ± 48.38	10.76 ± 29.06
CA199		99.06 ± 361.33	72.21 ± 283.09	233.27 ± 628.95
Total bilirubin		41.33 ± 36.58	43.91 ± 37.93	21.13 ± 10.4
Directly increase the proportion		2.64 ± 3.06	19.48 ± 21.73	7.04 ± 6.6
Indirect increase ratio		1.52 ± 1.13	24.43 ± 17.75	14.09 ± 4.93
Straight to straight ratio		0.82 ± 0.45	0.87 ± 0.44	0.45 ± 0.28
Albumin		43.48 ± 5.09	1.6 ± 1.18	0.93 ± 0.32
ALT/AST		0.76 ± 0.52	0.94 ± 0.98	0.36 ± 0.07
GGT		308.09 ± 289.23	43.52 ± 5.19	43.16 ± 4.39
ALP		166.2 ± 133.37	223.04 ± 241.17	73.29 ± 90.76
TBA		33.2 ± 54.3	130.9 ± 161.17	41.76 ± 39.36
Operative time		89.42 ± 28.76	0.75 ± 0.53	0.77 ± 0.4

CBD: Common bile duct diameter; WBC: White blood cell; HB: Hemoglobin; CRP: C-reactive protein; CA199: Carbohydrate antigen 199; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; GGT: γ-glutamyl transpeptidase; ALP: Alkaline phosphatase; TBA: Total bile acid.

Table 2 Single factor logistic regression screening for risk factors.

Factors	Coefficient	Z value	P value
Incidence	-0.9614	-1.5464	0.1220
History of diabetes	1.5041	1.6209	0.1050
History of hypertension	1.1436	1.8248	0.0680
Gallstones-multiple	-16.6943	-0.0102	0.9918
Gallstones-micro stones	-0.0834	-0.1180	0.9060
Common bile duct stones-single	0.2315	0.3712	0.7105
Common bile duct stones	0.3365	0.5420	0.5878
Common bile duct stones-micro stones	0.5306	0.7576	0.4487
Common bile duct stones-cellulose	2.1138	2.9930	0.0028
Common bile duct stones	-14.5401	-0.0105	0.9916
CBD	-0.2231	-0.1695	0.8654
WBC	-0.2557	-1.8175	0.0691
HB	-0.0043	-0.2297	0.8183
CRP	-0.0105	-0.8830	0.3772
CA199	0.0009	1.1705	0.2418
Total bilirubin	-0.0506	-2.0312	0.0422
Direct/indirect bilirubin	-7.0321	-2.8225	0.0048
Albumin	0.0000	0.0000	1.0000
ALT/AST	0.0731	0.1259	0.8998
GGT	0.0000	0.0000	1.0000
ALP	-0.0065	-1.3364	0.1814
TBA	-0.0024	-0.3707	0.7109
Operative time	0.0157	1.7035	0.0885
Suture method	0.3221	0.4915	0.6231

CBD: Common bile duct diameter; WBC: White blood cell; HB: Hemoglobin; CRP: C-reactive protein; CA199: Carbohydrate antigen 199; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; GGT: γ-glutamyl transpeptidase; ALP: Alkaline phosphatase; TBA: Total bile acid.

Using multiple logistic regression to screen independent risk factors

Perform multiple logistic regression analysis using factors that have a significant impact on single factor logistic regression as independent variables, as shown in Table 3. The above results indicate that common bile duct stones (cellulose) and the ratio of direct bilirubin/indirect bilirubin are independent risk factors for postoperative bile leakage (P < 0.05).

Table 3 Multivariate logistic regression analysis.

Factor	Partial regression coefficient	Error	Z value	P value	OR	95%CI
Common bile duct stones-cellulose	1.97008	0.77372	2.546	0.0109	7.171	1.705-38.400
Total bilirubin	-0.03732	0.02841	-1.314	0.189	0.963	0.903-1.010
Direct/indirect bilirubin	-5.60348	2.43206	-2.304	0.0212	0.004	0.000-0.154

OR: Odds ratio; CI: Confidence interval.

The impact of bile leakage on extubation time, discharge time, and total hospitalization costs

The rank sum test was used to examine whether bile leakage had a significant impact on extubation time, discharge time, and total hospitalization costs. The results are as follows (Table 4). The above results show that patients who did not experience bile leakage after surgery had significantly shorter extubation time and discharge time compared to patients who experienced bile leakage after surgery, with P < 0.05 and statistical significance.

Table 4 The impact of bile leakage on extubation time, discharge time, and total hospitalization costs, mean ± SD.

Factors	No bile leakage occurs	Gallbladder leakage occurs	Z value	P value
Pull out time	3.61 ± 1.25	5.33 ± 2.81	-2.627	0.009
Discharge time	5.77 ± 1.44	8.67 ± 6.49	-2.105	0.035
Total hospitalization expenses	15913.7 ± 3246.7	17249.28 ± 4344.86	-0.648	0.517

Learning curve

Obtain three fitting curves: Based on the proposed fitting curve, find the case number 51 with the maximum CUSUM value, which is the minimum number of surgeries required to cross the learning curve. The curve can be divided into two stages of surgical maturity, namely the stage of technical improvement and the stage of proficiency, based on the maximum value of CUSUM, which is 51. Using two groups as independent variables and postoperative bile leakage as the dependent variable, the logistic regression model shows that the surgical maturity stage significantly affects the occurrence of postoperative bile leakage (P = 0.023, Figure 1). The schematic diagram of gallbladder inflammation is shown in Figure 2 below.

Figure 1 Learning curve. The samples were sorted according to the order of surgery and the serial number was edited. The % scatter plot was drawn with cumulative summation value as the vertical axis and the number of cases as the horizontal axis. CUSUM: Cumulative summation, .

Figure 2 Gallbladder inflammation. A: The fibrous membrane covering the bile duct has not yet affected the patency of the nipple; B: The fibrous membrane in the bile duct affects the patency of the nipple; C: Nodular hyperplasia of bile duct mucosa (local); D: Nodular hyperplasia of bile duct mucosa (involving the entire bile duct mucosa).

DISCUSSION

The comprehensive evaluation of the duodenal papilla function of the duodenal papilla includes the sphincter of Oddi (SO) [mainly involving the contraction and relaxation function of the bile duct sphincter and the ampulla sphincter, as well as the smooth flow of the bile and pancreatic ducts, and diseases leading to So dysfunction (SOD)] mainly include: Fibrosis or chronic inflammation-induced Oddi sphincter stenosis: This is one cause of SOD, where fibrosis or chronic inflammation of the sphincter leads to narrowing, affecting the normal flow of bile and pancreatic juices. Congenital sphincter hypertrophy, and neuromuscular or hormonal factors causing intermittent spasmodic dysfunction: These causes involve congenital issues or abnormal neurohormonal regulation, leading to functional abnormalities of the Oddi sphincter. Post-cholecystectomy dysfunction: After gallbladder removal, the Oddi sphincter may experience dysfunction due to the loss of the gallbladder’s regulatory effect on bile duct pressure, leading to bile excretion disorders and SOD. Oddi sphincter dysfunction refers to a series of clinical syndromes caused by structural or functional abnormalities of the bile duct and/or pancreatic duct sphincter[10-12]. Low pressure in the bile duct and smooth flow in the bile and pancreatic duct junction are necessary prerequisites for effective healing of the bile duct first-phase incision and reducing bile leakage. For different levels of patency at the distal end of the laparoscopic common bile duct[13], laparoscopic duodenal papilla step by step dilatable catheter dilatation or laparoscopic duodenal papilla balloon dilatation is adopted. When necessary, laparoscopic endoscopic nasobiliary drainage or laparoscopic common bile duct stent is performed to ensure the patency of the duodenal papilla and maintain low pressure in the bile duct.

In this study, cases that did not undergo first-phase incision were mostly those in whom effective stone clearance could not be guaranteed, the conditions for bile duct wall closure were inadequate (such as significant needle hole leakage requiring multiple needle-point sutures but still unsatisfactory), severe bile duct inflammation requiring extended biliary decompression to increase perioperative safety and smooth recovery, a patient population unable to tolerate secondary surgery due to complications such as bile leakage, and the presence of factors such as liver hilum tumor that may lead to short-term extrinsic bile duct obstruction preventing the intraoperative placement of initial stents, advising against first-phase incision to prevent serious complications such as bile leakage and secondary surgeries, especially in elderly patients with relative contraindications.

Assessing the diameter of the common bile duct during surgery may be limited by factors such as differences in surgeons, inflammation of surrounding bile duct tissues preventing full visualization, and lack of effective measuring tools. Clinically, preoperative evaluations of the inner diameter of the common bile duct through methods such as color Doppler ultrasound, computed tomography, magnetic resonance cholangiopancreatography are more objective. However, the timing and methods of measurements using these various techniques differ, leading to significant variations in clinical measurements. In this study, millimeter intervals were used as the width of the common bile duct (the shortest length among the three examinations) for single-factor regression analysis regarding the occurrence of bile leakage, showing no significant statistical significance (P > 0.05).

For patients with common bile duct dilation greater than 8 cm, numerous clinical studies have confirmed that first-phase incision is safe and effective[14-16]. Given the lack of muscle layer in the extrahepatic bile ducts (primarily referring to the common bile duct), for patients with significant dilation (distinct from bile duct dilation), bile stasis, stone recurrence, and other long-term complications merit further clinical research. Animal experiments have shown that longitudinal incision of the bile duct does not lead to scar healing[17]. For individuals with a normal bile duct diameter that does not dilate due to sustained increase in bile duct pressure, it can be assumed that the SO function can maintain a good state of low pressure in the bile duct. This provides a theoretical basis for populations with smaller bile duct diameters. This study suggests that for patients with a common bile duct diameter < 8 mm, PDC can be safely performed without increasing the risk of long-term complications related to bile duct stricture.

Fibrinous inflammation often occurs on the mucous and serous membranes, referring to inflammatory exudate containing a large amount of fibrin protein. When there is biliary tract infection, the exuded fibrin, neutrophils, and necrotic mucosal tissues (the exuded fibrin coagulates) form a thin yellowish, elastic membrane covering the bile duct mucosa, known as pseudomembranous inflammation, which is often easily peeled off[18-21]. The substantial exudation of fibrinogen indicates severe vascular wall damage. In this study, the analysis of fibrinous exudate in the bile characteristic of acute biliary infection as a variable using single-factor and multi-factor regression analysis revealed that it is an independent risk factor for bile leakage postoperatively. In clinical practice, using basket retrieval for rotational removal, flushing of the bile duct is essential to ensure complete removal of intraluminal fibrinous covering, promoting smooth bile drainage and reducing the pressure buildup from bile stasis. Although the presence of fibrinous exudate in the common bile duct is an independent risk factor, the postoperative complication score for bile leakage (Clavien-Dindo classification) is grade 1, resolving with conservative observation. However, special attention is warranted for elderly patients, those with poor duodenal papillary function and patency, emphasizing cautious use of PDC.

Common suture techniques in clinical practice mainly include interrupted and continuous sutures; interrupted sutures are slower, have multiple knots, and are less effective in knotting outside the lumen, leading to slightly inferior hemostatic effects. The advantages of continuous sutures are less time-consuming, all knots are positioned outside the lumen, providing good hemostasis, yet disadvantages include a higher risk of tearing the thin and fragile bile duct wall, difficulty stitching into the biliary duct embedded in liver tissue, loose tying may result in bile leakage, while tight tension can lead to stricture at the anastomosis of tiny bile ducts.

Bile leakage post-PDC is often attributed to factors such as loose suture threads, minor leaks at the incision ends, or suture thread rupture at needle holes in thin-walled and narrow-bore bile ducts; increasingly, studies are optimizing the suture techniques for biliary ducts post-PDC, such as barbed suture (knotless) continuous sutures, layered sutures, full-thickness continuous eversion sutures, dual-needle bidirectional continuous sutures, and fibrin sealant coating[22-26]. Each suture technique has its advantages and disadvantages, balancing safety and trauma considerations, effectively reducing bile leak volume, and ease of adoption. These novel suture techniques have shown excellent clinical outcomes, worthy of further in-depth research in clinical practice.

Combining previous explorations, the author’s team has recently utilized the “continuous double-layer U-stitching technique,” achieving good clinical results. This technique can effectively prevent repeated pulling on the “first knot” and the suture segments (avoiding suture damage), reduce bile duct wall cutting (needle hole leaks), maintain consistent tension throughout (avoiding loose suture segments), promote tight and organized suture segments through a terminal “tissue knot,” effectively utilize peritoneal layer coverage to protect the biliary duct suture area, and reduce the impact of increased bile duct pressure on incision tension.

Jaundice resulting from elevated bilirubin levels can be roughly categorized as hepatocellular or obstructive; jaundice caused by biliary tract stones is primarily due to direct bilirubin elevation. Single-factor logistic regression analysis in this study indicates that the total bilirubin range for individuals without bile leakage is 43.91 ± 37.93 μmol/L, while the range for those with bile leakage is 21.13 ± 10.4 μmol/L, with a P value of 0.0422; the direct bilirubin ratio range for individuals without bile leakage is 0.87 ± 0.44, while that for individuals with bile leakage is 0.45 ± 0.28, with a P value of 0.0048, both being risk factors for postoperative bile leakage. Multi-factor logistic regression analysis demonstrates that the direct bilirubin ratio is an independent risk factor for bile leakage occurrence. This ratio is often overlooked in clinical practice, especially when the total bilirubin level is normal or mildly elevated, increasing the risk of bile leakage, emphasizing the need for further research and attention in clinical practice.

CONCLUSION

In the evaluation of duodenal papillary sphincter function, patency of the common bile duct and pancreatic duct, and successful completion of the learning curve for stone clearance, PDC remains the preferred method for biliary duct closure. The surgical strategy for common bile duct stones in the era of endoscopy needs further exploration and research in order to optimize management, improve patient outcomes, and minimize risks.