Efficacy of Percutaneous Transhepatic One-Stage Biliary Fistulization for Biliary Stricture with Hepatolithiasis after Liver Transplantation

Summary

This retrospective single‑center study evaluated percutaneous transhepatic one-stage biliary fistulization (PTOBF) in 25 post‑liver transplant patients with biliary stricture and stones. In this small cohort, PTOBF was associated with favorable stricture resolution and stone clearance rates, suggesting significant clinical potential. Prospective studies are needed to confirm efficacy and safety.

Abstract

With the increasing maturity of percutaneous transhepatic cholangioscopy and biliary drainage techniques, PTOBF has gradually emerged as a novel minimally invasive treatment for biliary strictures and hepatolithiasis. This retrospective single‑center study included 25 post‑liver transplant patients diagnosed with biliary strictures and stones between January 2022 and December 2025, aiming to further evaluate the clinical efficacy and safety of PTOBF. The degree of stricture, distribution of stones, total bilirubin (TBIL), direct bilirubin (DBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), fibrinogen (FIB), γ-glutamyl transpeptidase (r-GGT), prothrombin time (PT), C-reactive protein(CRP), postoperative complication rate, stricture resolution rate, and stone clearance rate, etc., were analyzed. A total of 73 PTOBF procedures were performed on the 25 patients to manage strictures. The mean bile duct diameter after dilatation was 5.472 ± 0.667 mm. The stricture resolution rate was 92.0% (23/25). During a mean follow-up period of 19.1 ± 8.2 months, the final stone clearance rate was 88.0% (22/25). Compared with preoperative levels, postoperative levels of DBIL, ALT, AST, and FIB were significantly reduced. In this small retrospective cohort, PTOBF was associated with favorable stricture resolution and stone clearance rates, suggesting significant clinical potential. Prospective studies are needed to confirm efficacy and safety.

Introduction

In 1963, the world's first liver transplantation was performed by Professor Starzl, known as the "Father of Liver Transplantation"¹. With rapid technological advancements, liver transplantation has become a common treatment modality for various end-stage liver diseases^2,3. However, a frequent complication following liver transplantation is biliary stricture, with an incidence rate of approximately 15–30%⁴, of which over 80% occur at anatomical locations such as the biliary anastomosis⁵. Biliary strictures can secondarily lead to a series of adverse symptoms, including cholangitis, hepatolithiasis, and decreased liver function, and may even cause serious consequences such as allograft rejection and graft failure⁶. Clinically, endoscopic retrograde cholangiopancreatography (ERCP) has been preliminarily applied in the interventional treatment of post-transplant biliary strictures. However, ERCP techniques often require incision of the duodenal papillary sphincter, a drawback that has sparked considerable debate⁷.

Currently, the treatment of biliary strictures after liver transplantation remains a medical challenge, often necessitating multiple courses of sequential surgical interventions, including dilatation of the strictured bile duct, stent placement, and stone clearance^8,9. Percutaneous transhepatic one-stage biliary fistulization (PTOBF) involves successful percutaneous transhepatic bile duct puncture under ultrasound guidance, followed by direct dilation of the tract to 16F, insertion of a protective sheath, and subsequent use of a rigid choledochoscope for stone removal and management of biliary strictures. This procedure has been preliminarily applied in the clinical intervention of biliary tract disease^10,11,12. However, the application of PTOBF specifically for post‑liver transplant biliary strictures with stones has not been systematically evaluated. Therefore, this retrospective study aims to precisely evaluate the clinical outcomes of PTOBF in post‑liver transplant patients with biliary strictures and concomitant hepatolithiasis. The predefined outcomes include stricture resolution rate, stone clearance rate, procedure‑related complications, and changes in liver function biomarkers (DBIL, ALT, AST, FIB, TBIL, γ‑GGT, PT) and inflammatory marker (CRP).

This study provides novel clinical evidence regarding the efficacy and safety of PTOBF in post-liver transplantation biliary strictures with concomitant hepatolithiasis. The findings may support the broader clinical application of PTOBF as a minimally invasive one-stage intervention strategy.

Protocol

This study was reviewed and approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University (No.YKLS201709). The ethics committee approved a waiver of informed consent for this retrospective analysis of medical records. Written informed consent was obtained from all patients for the PTOBF procedure. The images presented in the article were obtained with the patients' full informed consent.

A retrospective analysis was conducted of the clinical data of 25 patients with biliary strictures who underwent liver transplantation and were treated with PTOBF at the First Affiliated Hospital of Guangzhou Medical University from January 2022 to December 2025. All consecutive patients who met the inclusion criteria were included. If a patient underwent multiple PTOBF procedures and had multiple postoperative test results, the analysis results from all procedures were collected. The cohort included 24 male patients and 1 female patient. Inclusion criteria: diagnosed as post-liver transplantation status by preoperative imaging or medical history inquiry, concurrently complicated with biliary stricture; underwent percutaneous transhepatic one-stage biliary fistulization choledochoscopy surgery; preoperative liver function Child-Pugh grade A or B; underwent preoperative contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI) examinations. Exclusion criteria: concurrent liver cancer or cholangiocarcinoma; severe coagulation disorders; allergy to the contrast agent iopromide.

PTOBF procedure
The main processes of PTOBF are shown in Figure 1. The materials involved in this process can be found in the "Table of Materials" file. Based on preoperative magnetic resonance cholangiopancreatography (MRCP), ultrasound, and other imaging examinations, the location of hepatolithiasis and the degree of biliary stricture were assessed (Figure 1A). The choice of puncture approach was determined by the target bile duct: for left intrahepatic bile ducts, an anterolateral approach was used to puncture segment 2 or segment 3; for right intrahepatic bile ducts, an intercostal approach was used to puncture segment 5 or segment 8 (Figure 1B–C). After the puncture needle accurately entered the target bile duct and smooth bile drainage was observed, a guidewire was immediately inserted. Using a one‑step method, an 8F dilator was introduced percutaneously along the guidewire into the liver, and successively larger dilators were exchanged to gradually dilate the tract to 16F. Subsequently, a 16F protective sheath was advanced together with the dilator into the bile duct; the dilator was withdrawn, leaving the distal end of the sheath within the hepatobiliary duct, thereby establishing an artificial passage connecting the hepatobiliary duct to the external environment (Figure 1D). After choledochostomy was completed, a choledochoscope was inserted and advanced along the biliary tree to select the target bile duct for further stone extraction and stricture dilation. Every effort was made to achieve complete stone clearance and to correct the stricture. Membranous strictures were dilated directly using a rigid choledochoscope and sheath: based on the degree of luminal narrowing, the diameter of the rigid choledochoscope tip was used as a reference, and blunt dilation was performed by placing a guidewire and a drainage tube. For tubular strictures, electrocautery incisions were made at the 3, 6, 9, and 12 o’clock positions (with the routine placement of a dispersive electrode plate; cutting power set at 15 W and coagulation power at 20 W), or combined with balloon dilation (balloon size selected according to the anastomotic diameter, typically 6–8 mm; after passing through the stricture, contrast medium was injected to inflate the balloon under pressure, gradually reaching 1.01 × 10⁶ Pa and maintained for 3–5 min) (Figure 1E). Under C‑arm X‑ray guidance, an 18F support drainage tube was placed beyond the distal end of the stricture. A drainage tube was left in the tract postoperatively, cholangiography was performed to assess biliary patency, and postoperative CT cholangiography was repeated to evaluate the outcome of the PTOBF procedure.

Follow-up
All 25 patients were successfully followed up via telephone and outpatient visits, with a mean follow-up period of (19.1 ± 8.2) months. The follow-up deadline was December 31, 2025.

Outcome measures
The main blood parameters observed were total bilirubin (TBIL), direct bilirubin (DBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), fibrinogen (FIB), gamma‑glutamyl transferase (γ-GGT), prothrombin time (PT), and C‑reactive protein (CRP) before and after the procedure. In addition, operative time, number of procedures, postoperative complication rate, stricture resolution rate, and stone clearance rate were analyzed. Biliary strictures were classified as severe or mild‑to‑moderate: Severe stricture was defined as a diameter ratio of the proximal bile duct at the stricture to the dilated distal bile duct < 1/2 on imaging, or the presence of a tubular or “door‑gap‑like” stricture under choledochoscopy. Mild‑to‑moderate stricture was defined as a diameter ratio ≥ 1/2 on imaging, or a membranous stricture under choledochoscopy. Resolution of the hepatic duct stricture and stone clearance were determined by intraoperative and postoperative cholangioscopy and imaging analyses. The stone clearance rate was defined as the proportion of patients with no residual stones after the final procedure and no detection of hepatolithiasis during follow‑up. The stricture resolution rate was defined as the proportion of patients with no evidence of biliary stricture during follow‑up after the final procedure. Stone recurrence was defined as the proportion of patients in whom intrahepatic bile duct stones were diagnosed by imaging more than six months after the final treatment during the follow‑up period.

Safety assessment
Among the 25 patients, one experienced intraoperative bleeding. Under choledochoscopy, the bleeding bile duct mucosa was locally irrigated with normal saline containing norepinephrine, which induced local vasospasm and reduced bleeding. Within 24 h after the procedure, the drainage fluid from the biliary drainage tube was light yellow, with no bloody fluid observed. Within one month postoperatively, a total of three complications occurred among the 25 patients, including two cases of septic shock and one case of chronic liver failure. After treatment, including anti-infection therapy, fluid resuscitation, enzyme inhibition, acid suppression, and fasting, all patients showed symptom improvement. During the follow‑up period, only one of the 25 patients developed liver failure three months after the procedure. All patients who experienced complications related to PTOBF in this study were on daily immunosuppressive therapy. The occurrence of complications may be associated with their own immunosuppressive status or may be the result of a combination of the PTOBF procedure and the patients’ underlying condition. Clinical, symptomatic, and supportive treatment was administered. This study retrospectively collected patient data.

Statistical analysis
Statistical analysis was performed using SPSS 25.0 software and SPSSAU. Normally distributed continuous data were reported as mean ± standard deviation (x̄ ± s), and comparisons between groups were conducted using the paired or independent-samples t-test. Categorical data were described as frequencies and percentages, and comparisons between groups were conducted using the χ² test. A p-value < 0.05 was considered statistically significant.

Results

Baseline patient characteristics
A total of 25 patients with biliary strictures after liver transplantation were enrolled in this study. The mean age was (51.760 ± 15.954) years. Among them, 22 patients had anastomotic strictures of the bile duct after liver transplantation. Biliary strictures occurred more than 10 years after liver transplantation in 9 patients and within 5 years after liver transplantation in 11 patients. There were 18 patients with severe strictures and 7 with moderate strictures....

Discussion

Patients with biliary strictures and concomitant stones after liver transplantation often present with poor physical condition and complex biliary anatomy, typically requiring multiple surgical procedures and resulting in high rates of residual stones. Consequently, minimally invasive approaches for relieving biliary strictures and clearing stones have emerged as a new generation of treatment modalities¹³. With technological advancements, following open biliary reconstruction, ERCP has become the ...

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Abdominal probe	Hitachi Aloka	5–1 MHz C25P	Used in anaylsis
Biliary balloon dilation catheter	Changmei Medical Equipment Co., Ltd.	6 mm × 6 cm	Used in surgical procedure
Center-slotted puncture guide / Center-slotted needle guide	Hitachi Aloka	0°-15°-30°	Used in anaylsis
Color Doppler ultrasound diagnostic system	Hitachi Aloka	S-70	Used in anaylsis
Electrosurgical system	HuTong	GD350-B	Used in surgical procedure
Fascial dilator	HuaMei	8 ~ 16 F	Used in surgical procedure
Hydrophilic guidewire	COOK	0.035 inch × 150 cm	Used in surgical procedure
Intracavitary irrigation pump	Jielun	NA	Used in surgical procedure
Normal saline	Sihao Pharmaceutical Co., Ltd.	100 mL	Used in surgical procedure
Pneumatic intracorporeal lithotripter	APL	APL-2	Used in surgical procedure
PTC needle (Percutaneous Transhepatic Cholangiography needle)	COOK	18 G	Used in surgical procedure
Rigid choledochoscope	Richard Wolf GmbH	12 F × 33 cm	Used in surgical procedure
Stone grasping forceps	KangJi	5 F	Used in surgical procedure
Stone retrieval basket	PuRuiXiSi	2.2Fr	Used in surgical procedure