Clinical Trial

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

Not Yet Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-09.
Trial Details
NCT Number NCT07532759
Lead Sponsor Xu'an Wang
Conditions Obstructive Jaundice, Pancreatic Head Cancer, Periampullary Neoplasms, Biliary Tract Neoplasms
Enrollment 100 participants
Start Date 2026-08-01
Primary Completion 2028-02-28 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-15