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

Официальное название

Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice: An Exploratory Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура PTCD 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.
• Процедура PTCD 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.

Первичные конечные точки

• Composite rate of major postoperative complications [Срок оценки: Up to 90 days]

Вторичные конечные точки (8)

• B/C-grade bile leak [Срок оценки: Up to 90 days]
• B/C-grade pancreatic fistula [Срок оценки: Up to 90 days]
• Postoperative infections [Срок оценки: Up to 90 days]
• Time to gastrointestinal recovery [Срок оценки: Up to 30 days]
• Length of hospital stay [Срок оценки: Perioperative]
• Time to initiation of adjuvant therapy [Срок оценки: Up to 90 days]
• 90-day readmission rate [Срок оценки: Up to 90 days]
• 90-day mortality [Срок оценки: Up to 90 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07532759 · KY2026117

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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