Biliary Tract Neoplasms, Obstructive Jaundice, Pancreatic Head Cancer, Periampullary Neoplasms
Conditions
Keywords
Pancreaticoduodenectomy, PTCD, Biliary drainage, Biliary complications, Bile leak, Enhanced recovery, Randomized controlled trial
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.
Detailed description
This multicenter, prospective, randomized controlled trial is designed to evaluate the impact of intraoperative management of preoperative percutaneous transhepatic cholangial drainage (PTCD) catheters on postoperative outcomes in patients undergoing pancreaticoduodenectomy (PD). Participants meeting eligibility criteria will be randomly assigned in a 1:1 ratio to either intraoperative PTCD catheter removal or retention using a centralized randomization system with stratification by study center and a concealed block design. The study follows a parallel-group design without crossover. Perioperative management, including surgical technique, postoperative care, and complication management, will be standardized across participating centers according to predefined protocols to minimize inter-center variability. Outcome assessment will be conducted by independent evaluators blinded to treatment allocation. Data will be collected prospectively using an electronic data capture (EDC) system with built-in validation rules, audit trails, and centralized monitoring to ensure data quality and integrity. The primary analysis will focus on estimating the effect size and corresponding confidence intervals for the predefined outcomes, rather than formal hypothesis testing, given the exploratory nature of the study. Multicenter effects will be accounted for in the analysis by incorporating study center as a stratification factor or covariate. Participants will be followed for 90 days after surgery, during which predefined clinical outcomes and safety data will be systematically recorded. The findings of this study are intended to generate high-quality preliminary evidence to inform optimal intraoperative PTCD management strategies and support the design of future confirmatory trials.
Interventions
PROCEDUREPTCD Catheter Removal
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.
PROCEDUREPTCD Catheter Retention
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.
Sponsors
Xu'an Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite rate of major postoperative complications | Up to 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| B/C-grade bile leak | Up to 90 days | Incidence of B/C-grade bile leak defined according to ISGLS criteria. |
| B/C-grade pancreatic fistula | Up to 90 days | Incidence of clinically relevant postoperative pancreatic fistula (grade B/C) defined by ISGPS criteria. |
| Postoperative infections | Up to 90 days | Incidence of postoperative infections, including intra-abdominal infection, biliary infection, pulmonary infection, and wound infection. |
| Time to gastrointestinal recovery | Up to 30 days | Time to first flatus and time to first oral intake after surgery. |
| Length of hospital stay | Perioperative | Total duration of hospitalization after surgery. |
| Time to initiation of adjuvant therapy | Up to 90 days | Time from surgery to initiation of postoperative adjuvant therapy. |
| 90-day readmission rate | Up to 90 days | Proportion of patients readmitted within 90 days after surgery. |
| 90-day mortality | Up to 90 days | All-cause mortality within 90 days after surgery. |
Contacts
CONTACTXu'an Wang, Doctor
Outcome results
None listed