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
Parallel
PTCD Catheter Removal
Procedure/SurgeryThe 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 Retention
Procedure/SurgeryThe 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.
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.
B/C-grade bile leak
Incidence of B/C-grade bile leak defined according to ISGLS criteria.
B/C-grade pancreatic fistula
Incidence of clinically relevant postoperative pancreatic fistula (grade B/C) defined by ISGPS criteria.
Postoperative infections
Incidence of postoperative infections, including intra-abdominal infection, biliary infection, pulmonary infection, and wound infection.
Time to gastrointestinal recovery
Time to first flatus and time to first oral intake after surgery.
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Xu'an Wang
Lead sponsor
Fudan University
Sponsor institution
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