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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Biliary Tract Neoplasms; Obstructive Jaundice; Periampullary Neoplasms; Pancreatic Head Cancer
• Intervention / Treatment: Procedure: PTCD Catheter Removal; Procedure: PTCD Catheter Retention

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xu'an Wang, Doctor; Phone Number: +86-15216680015; Email: wang.xu_an@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 to 85 years
• Patients with pancreatic head or periampullary tumors scheduled for pancreaticoduodenectomy
• Presence of obstructive jaundice and completion of preoperative
• percutaneous transhepatic cholangial drainage (PTCD)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• American Society of Anesthesiologists (ASA) physical status ≤ II
• Able to understand the study and provide written informed consent

Exclusion Criteria:

• Presence of distant metastasis or locally unresectable disease
• Severe cardiac, renal, or pulmonary dysfunction that contraindicates surgery
• Uncontrolled infection
• Pregnancy or breastfeeding
• History of major surgery within 4 weeks prior to enrollment
• Poor compliance or inability to complete follow-up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PTCD Catheter Removal Group; Participants assigned to this arm will undergo intraoperative removal of the preoperative PTCD catheter during pancreaticoduodenectomy. The catheter will be removed after completion of the biliary-enteric anastomosis, followed by routine closure of the hepatic duct puncture site. No external biliary drainage will be maintained postoperatively, and only standard abdominal drainage will be placed.	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.
Experimental: PTCD Catheter Retention Group; Participants assigned to this arm will undergo intraoperative retention of the preoperative PTCD catheter during pancreaticoduodenectomy. The catheter will be maintained as a stent for the biliary-enteric anastomosis and used for postoperative external drainage. Planned catheter removal will be performed approximately 4 weeks after surgery following confirmation of biliary patency by clamping trial and cholangiography.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite rate of major postoperative complications	Incidence of a composite endpoint defined as B/C-grade bile leak according to the International Study Group of Liver Surgery (ISGLS) criteria or Clavien-Dindo grade ≥ III complications occurring after pancreaticoduodenectomy.	Up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
B/C-grade bile leak	Incidence of B/C-grade bile leak defined according to ISGLS criteria.	Up to 90 days
B/C-grade pancreatic fistula	Incidence of clinically relevant postoperative pancreatic fistula (grade B/C) defined by ISGPS criteria.	Up to 90 days
Postoperative infections	Incidence of postoperative infections, including intra-abdominal infection, biliary infection, pulmonary infection, and wound infection.	Up to 90 days
Time to gastrointestinal recovery	Time to first flatus and time to first oral intake after surgery.	Up to 30 days
Length of hospital stay	Total duration of hospitalization after surgery.	Perioperative
Time to initiation of adjuvant therapy	Time from surgery to initiation of postoperative adjuvant therapy.	Up to 90 days
90-day readmission rate	Proportion of patients readmitted within 90 days after surgery.	Up to 90 days
90-day mortality	All-cause mortality within 90 days after surgery.	Up to 90 days

Collaborators and Investigators

• Sponsor: Xu'an Wang

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Biliary drainage; Pancreaticoduodenectomy; Biliary complications; Enhanced recovery; PTCD; Bile leak
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Hyperbilirubinemia; Skin Manifestations; Biliary Tract Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Jaundice; Biliary Tract Neoplasms; Jaundice, Obstructive
• Other Study ID Numbers: KY2026117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No