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

Starting soon · Not applicable

Conditions studied: Obstructive Jaundice, Pancreatic Head Cancer, Periampullary Neoplasms, Biliary Tract Neoplasms

In brief

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.

Key facts

Study ID

NCT07532759

Run by

Xu'an Wang

People needed

100

Starts

2026-08-01

Expected to finish

2028-04-30

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Full record on ClinicalTrials.gov

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