Total Pancreatectomy or High-risk Pancreatic Anastomosis After Pancreatoduodenectomy (TETRIS): a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 10
- 主要终点
- Major morbidity
研究概览
简要总结
Postoperative pancreatic fistula (POPF) is the main driver of surgical morbidity after pancreatoduodenectomy (PD). The aim of the present study is to compare total pancretectomy (TP) and primary pancreatic anastomosis (PA) in a cohort of extremely high-risk patients, with regards to postoperative outcomes and quality of life (QoL).
详细描述
The study will be organized as a multicentric randomized controlled trial. When a patient will be considered eligible preoperatively, he or she will be enrolled in the present study. The patient's risk will be allocated intraoperatively after the demolitive time and before pancreatic anastomosis, according to the following criteria:
- Major Criteria: main pancreatic duct diameter ≤3mm; soft pancreas
- Minor Criteria: bleeding stump; friable stump; posterior/eccentric duct; invisible duct; deep pancreas; intraoperative acute pancreatitis; FRS 9-10
- Interobserver agreement ≥2 Surgeons
Patients presenting with all major criteria (stage D according to Schuh et al.) and at least one among the minor criteria will be considered eligible. At least two surgeons must confirm eligibility, according to interobserver agreement regarding the above-mentioned criteria and ethical applicability of randomization (ethical "guarantor"). Eligible patients will be randomized to receive PA or TP.
Pre-operative, intra-operative and post-operative data will be recorded prospectively by the P.I. and by his collaborators.
Preoperative care Preoperative care will follow institutional standards, according to each center involved. After obtaining the informed consent for elective pancreatic resection and after adequate counselling, the study will be proposed to the patient. If the patient will accept, the informed consent will be obtained. The physician who will get the informed consent for the procedure will also be responsible for the consent to the study. Randomization lists will be provided for each Center and for each randomized group. All patients will be preoperatively checked for diabetes by measuring fasting blood glucose (FBG) and glycated hemoglobin (Hb1Ac), C- peptide, and for pancreatic exocrine insufficiency by associated clinical criteria and fecal elastase-1 (FE-1) determination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •All patients scheduled for PD for all kind of pancreatic diseases
- •Patients able to give their informed consent
- •Patients undergoing PD (Kausch-Whipple or Longmire-Traverso)
- •Patients presenting two major and at least one minor criteria (Major criteria: Main pancreatic duct diameter ≤3mm; Soft pancreas. Minor criteria: Bleeding stump; Friable stump; Posterior/Eccentric duct; Invisible duct; Deep pancreas; Intraoperative acute pancreatitis; FRS 9-10)
- •Two or more surgeons confirming eligibility
- •PA or TP with or without spleen preservation (Kimura technique). These techniques are consistent with clinical practice; any other procedure will be a deviation from the protocol
排除标准
- •Informed consent withdrawal
- •Impossibility to undergo surgery for any reason
- •Main pancreatic duct of the pancreatic neck/body >3mm at preoperative imaging (CT scan or MRI)
- •PD not performed for any reason
- •Absence of two major criteria
- •Absence of at least one minor criteria
- •Absence of interobserver agreement between at least 2 surgeons
- •More than 1 extension of resection to pancreatic neck due to pancreatic margin positivity
- •Wrong randomization
结局指标
主要结局
Major morbidity
时间窗: 90 postoperative days.
Rate of postoperative major morbidity, defined as Clavien-Dindo≥ 3.
次要结局
- Mortality(90 postoperative days.)
- Time-to-functional recovery.(90 postoperative days.)
- Access to adjuvant chemotherapy(24 months after discharge.)
- Diabetes-related QoL(24 months after discharge.)
- Postoperative complications(90 postoperative days.)
- Postoperative endocrine insufficiency(24 months after discharge.)
- Delay in starting adjuvant chemotherapy.(24 months after discharge.)
- Postoperative pancreatitis(90 postoperative days.)
- Postoperative morbidity(90 postoperative days.)
- Length of hospital stay(90 postoperative days.)
- Postoperative exocrine insufficiency(24 months after discharge.)
- General QoL(24 months after discharge.)
- Postoperative pancreatic fistula (POPF)(90 postoperative days.)
- Biochemical leak(90 postoperative days.)
- Pancreas-specific QoL(24 months after discharge.)
- Cancer-specific QoL(24 months after discharge.)