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

NCT07532759 | Not Yet Recruiting DMC

• 1 other identifier: KY2026117
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Pancreaticoduodenectomy; PTCD; Biliary drainage; Biliary complications; Bile leak; Enhanced recovery; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• B/C-grade bile leak

  Up to 90 days

• B/C-grade pancreatic fistula

  Up to 90 days

• Postoperative infections

  Up to 90 days

• Time to gastrointestinal recovery

  Up to 30 days

• Length of hospital stay

  Perioperative

Study Arms (2)

PTCD Catheter Removal Group

EXPERIMENTAL

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

PTCD Catheter Retention Group

EXPERIMENTAL

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

Interventions

PTCD Catheter Removal PROCEDURE

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.

PTCD Catheter Removal Group

PTCD Catheter Retention PROCEDURE

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.

PTCD Catheter Retention Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xu'an Wang: lead

MeSH Terms

Conditions

Jaundice, Obstructive; Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Xu'an Wang, Doctor

CONTACT

+86-15216680015; wang.xu_an@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is an open-label study in which participants and surgeons are not blinded due to the nature of the intervention. However, outcome assessors are blinded to group allocation. All postoperative outcomes are evaluated by independent assessors who are not involved in the surgical procedures and have no access to treatment assignment. Relevant clinical data are de-identified prior to assessment to remove any information that may reveal group allocation. In addition, data analysts are blinded to group allocation during the primary analysis, with treatment groups labeled as "A" and "B" until completion of the primary analysis and interpretation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: intraoperative removal or retention of the preoperative PTCD catheter during pancreaticoduodenectomy. Randomization will be stratified by study center using a block design to ensure balanced allocation within each center. The study follows a parallel-group design without crossover, and all participants will receive the allocated intervention during a single surgical procedure and be followed prospectively for 90 days.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share