Impact of Intraoperative PTCD Catheter Retention Versus Removal on Postoperative Short-term Outcomes After Pancreaticoduodenectomy in Obstructive Jaundice: An Exploratory Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Composite rate of major postoperative complications
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PTCD Catheter Removal Group
Participants assigned to this arm will undergo intraoperative removal of the preoperative PTCD catheter during pancreaticoduodenectomy. The catheter will be removed after completion of the biliary-enteric anastomosis, followed by routine closure of the hepatic duct puncture site. No external biliary drainage will be maintained postoperatively, and only standard abdominal drainage will be placed.
干预措施: PTCD Catheter Removal (Procedure)
PTCD Catheter Retention Group
Participants assigned to this arm will undergo intraoperative retention of the preoperative PTCD catheter during pancreaticoduodenectomy. The catheter will be maintained as a stent for the biliary-enteric anastomosis and used for postoperative external drainage. Planned catheter removal will be performed approximately 4 weeks after surgery following confirmation of biliary patency by clamping trial and cholangiography.
干预措施: PTCD Catheter Retention (Procedure)
结局指标
主要结局
Composite rate of major postoperative complications
时间窗: 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.
次要结局
- Length of hospital stay(Perioperative)
- B/C-grade bile leak(Up to 90 days)
- B/C-grade pancreatic fistula(Up to 90 days)
- Postoperative infections(Up to 90 days)
- Time to gastrointestinal recovery(Up to 30 days)
- Time to initiation of adjuvant therapy(Up to 90 days)
- 90-day readmission rate(Up to 90 days)
- 90-day mortality(Up to 90 days)
研究者
Xu'an Wang
Professor
Fudan University