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.
