Prophylactic EUS-guided Gastroenterostomy in Advanced Periampullary Cancers: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 6
- 主要终点
- Rate of gastric outlet obstruction (GOO)
研究概览
简要总结
The goal of this randomized controlled trial is to investigate the effectiveness and safety of Prophylactic EUS-gastroenterostomy (ProEUS-GE) as a preventative approach for malignant gastric outlet obstruction (MGOO) in men and women aged 18 years or older diagnosed with periampullary cancer.
The main question this study aims to answer is can ProEUS-GE effectively prevent the occurrence of MGOO in patients with periampullary cancer?
Patients will be randomly assigned to one of two groups: Group 1 (ERCP alone) or Group 2 (ERCP + ProEUS-GE). The study will compare the outcomes between these groups to determine the effectiveness of ProEUS-GE in preventing MGOO.
Researchers will compare Group 1 (ERCP alone) with Group 2 (ERCP + ProEUS-GE) to see if the addition of ProEUS-GE leads to a reduced occurrence of MGOO in patients with periampullary cancer.
The primary endpoint is the rate of malignant gastric outlet obstruction.
详细描述
Research Question:
The principal research question is whether ProEUS-GE can prevent the occurrence of MGOO in patients with pancreatic head cancer. We hypothesize that the addition of ProEUS-GE during ERCP reduces the rate of development of subsequent MGOO in advanced periampullary solid cancer without significantly increasing the rate of adverse events when compared to ERCP alone.
The Proposed Trial Trial Design: This is a patient- and outcome assessor-blinded multicentre randomized controlled superiority trial. The endoscopist performing the procedure will not be blinded to treatment allocation.
Planned Trial Interventions: 1) ERCP with biliary decompression + prophylactic EUS-guided gastroenterostomy (ProEUS-GE) and 2) ERCP with biliary decompression alone. All procedures will be performed by experienced endoscopists with or without trainee involvement. Following informed consent, sedation will be via conscious sedation or general anesthesia, as per existing institutional procedural protocols. A medical effectiveness approach will be adopted where only the initial randomly allocated treatment is dictated by the trial.
Participant Allocation: After confirmation of fulfillment of all study inclusion/exclusion criteria and pre-procedural consent, patients will be randomly allocated, intra-procedurally during the ERCP, to one of the two approaches.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
As with most procedural interventional trials, blinding of the endoscopist is not feasible. To limit detection biases, outcome assessors and patients are blinded to the treatment allocation. Outcome assessors are independent individuals not involved with patient consent or randomization and not present at the index procedure.
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
- •(all of the following):
- •Radiological diagnosis of a periampullary cancer that is precluded from upfront surgical resection of curative intent due to advanced tumor stage. These include locally advanced or metastatic cancers of the pancreatic head, distal bile duct, duodenum, or ampulla. cancers.
- •Elevated liver function tests requiring ERCP without evidence of MGOO of significant gastroparesis (see exclusion criterion #3 and #4)
- •ECOG 0 or 1
- •Provision of informed consent
排除标准
- •(any of the following):
- •Patient with clinical and radiological evidence of malignant gastric outlet obstruction defined as Gastric Outlet Obstruction Scoring System (GOOSS) of < 3 with radiological and/or endoscopic evidence of a mechanical obstruction from a gastric or duodenal stricture. GOOSS is a validated tool for assessing MGOO and is scored based on the diet tolerated by the patient: 0 for no oral intake, 1 for liquids only, 2 for soft diet, and 3 for low residue or full diet.
- •Gastroparesis with a Gastroparesis Cardinal Symptom Index (GCSI) of >
- •Gastroparesis is defined as having symptoms of MGOO without radiological and/or endoscopic evidence of mechanical obstruction.
- •Uncorrectable coagulopathy and/or thrombocytopenia
- •Age < 18 or ≥ 85
- •Evidence of peritoneal carcinomatosisAscites
- •Liver metastasis > 30% of the liver volume
- •Portal hypertension with gastroesophageal varices and/or ascites
- •Surgically altered upper gastrointestinal anatomy
结局指标
主要结局
Rate of gastric outlet obstruction (GOO)
时间窗: 18 months
Gastric outlet obstruction is defined as GOOSS of \< 2 AND radiological and/or endoscopic confirmation of the presence of GOO either from a gastroduodenal stricture, stent obstruction, or stent migration.
次要结局
- Quality of life of the participant(18 months)
- Nutritional status(18 months)
- Rate of adverse events(18 months)
研究者
Yen-I Chen
assistant professor of medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre