NCT07532759

Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice

Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice: An Exploratory Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Xu'an Wang · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Pancreaticoduodenectomy (PD) is a complex surgical procedure commonly performed for tumors of the pancreatic head and periampullary region. Many patients present with obstructive jaundice and undergo preoperative percutaneous transhepatic cholangial drainage (PTCD) to relieve biliary obstruction. However, there is currently no consensus on whether the PTCD catheter should be removed or retained during surgery. This multicenter, prospective randomized controlled trial aims to compare two intraoperative strategies: removal versus retention of the PTCD catheter during PD. Participants will be randomly assigned to either group. The study will evaluate whether these different approaches influence postoperative outcomes, particularly major complications such as bile leak and severe postoperative morbidity within 90 days after surgery. In addition to complications, the study will assess recovery after surgery, including return of gastrointestinal function, length of hospital stay, and quality of recovery, as well as laboratory indicators of liver function and inflammation. The results of this study are expected to provide evidence to guide surgical decision-making regarding PTCD management during PD and to improve patient outcomes.

Detailed description

This multicenter, prospective, randomized controlled trial is designed to evaluate the impact of intraoperative management of preoperative percutaneous transhepatic cholangial drainage (PTCD) catheters on postoperative outcomes in patients undergoing pancreaticoduodenectomy (PD). Participants meeting eligibility criteria will be randomly assigned in a 1:1 ratio to either intraoperative PTCD catheter removal or retention using a centralized randomization system with stratification by study center and a concealed block design. The study follows a parallel-group design without crossover. Perioperative management, including surgical technique, postoperative care, and complication management, will be standardized across participating centers according to predefined protocols to minimize inter-center variability. Outcome assessment will be conducted by independent evaluators blinded to treatment allocation. Data will be collected prospectively using an electronic data capture (EDC) system with built-in validation rules, audit trails, and centralized monitoring to ensure data quality and integrity. The primary analysis will focus on estimating the effect size and corresponding confidence intervals for the predefined outcomes, rather than formal hypothesis testing, given the exploratory nature of the study. Multicenter effects will be accounted for in the analysis by incorporating study center as a stratification factor or covariate. Participants will be followed for 90 days after surgery, during which predefined clinical outcomes and safety data will be systematically recorded. The findings of this study are intended to generate high-quality preliminary evidence to inform optimal intraoperative PTCD management strategies and support the design of future confirmatory trials.

Conditions

• Obstructive Jaundice
• Pancreatic Head Cancer
• Periampullary Neoplasms
• Biliary Tract Neoplasms

Interventions

Type	Name	Description
PROCEDURE	PTCD Catheter Removal	The preoperative percutaneous transhepatic cholangial drainage (PTCD) catheter is removed intraoperatively during pancreaticoduodenectomy. Removal is performed after completion of the biliary-enteric anastomosis, followed by closure of the hepatic duct puncture site. No external biliary drainage is maintained postoperatively, and only standard abdominal drainage is used.
PROCEDURE	PTCD Catheter Retention	The preoperative percutaneous transhepatic cholangial drainage (PTCD) catheter is retained intraoperatively during pancreaticoduodenectomy. The catheter is used as a stent to support the biliary-enteric anastomosis and is maintained for postoperative external biliary drainage. Planned removal is performed approximately 4 weeks after surgery following confirmation of biliary patency by clamping trial and cholangiography.

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-02-28
• Completion: 2028-04-30
• First posted: 2026-04-16
• Last updated: 2026-04-16