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.
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)
Presence of distant metastasis or locally unresectable disease
Severe cardiac, renal, or pulmonary dysfunction that contraindicates surgery
Uncontrolled infection
Pregnancy or breastfeeding
Xu'an Wang
Lead sponsor
Fudan University
Sponsor institution