Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 5
- 主要终点
- Time to initiation of solid oral intake without symptoms of GOO
研究概览
简要总结
Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment
详细描述
After potential subjects are screened from the physicians' schedules, they will be assessed for further inclusion criteria. They will be presented with the informed consent form for their review. Once they have been given the opportunity to review and ask questions, they will sign the consent form and from this point will be considered enrolled into the study.
After signing the informed consent, subjects will be randomized to one of the two cohorts in a 1:1 manner.
On the day of their assigned procedures, subjects will be asked several quality of life questionnaires to obtain a baseline status.
Data will be collected during and immediately following the procedure to assess for any possible adverse events.
Follow-up data will be completed at the following timepoints: 1-day, 2-day, 3-day, 4-day, and 7-day, 30-day, 3-month, 6-month, and 1-year post-procedure.
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
- 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
- •Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer
- •Symptoms of gastric outlet obstruction (at least 2 of 4 required):
- •post prandial vomiting,
- •abdominal pain,
- •inability to tolerate PO,
- •imaging consistent with GOO
- •Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only)
- •Age >18 years old
- •Life expectancy greater than 2 months or failed duodenal stenting
- •Surgical Candidate/Tolerate General Anesthesia
- •Unresectable or metastatic disease
排除标准
- •Age< 18 years old
- •Intestinal obstruction distal to the Ligament of Treitz
- •Evidence of other luminal strictures of the GI tract
- •Previous gastric or periampullary surgery
- •Inability to complete quality of life surveys (QOLS)
- •Presence of abdominal ascites
结局指标
主要结局
Time to initiation of solid oral intake without symptoms of GOO
时间窗: 1 year
Days to initiation of solid oral intake will be measured from randomization to first day of intake of soft solid foods, as indicated by a GOOSS score of 2
次要结局
- Technical success of procedure(1 year)
- Time to discharge(1 year)
- Safety of procedure(1 year)
- Chemotherapeutic regimen tolerance(30 Days)
- Clinical success of procedure(1 year)
- Change in albumin levels(3 months)
- Change in BMI(3 months)
- Change in Gut Function Score (GFS)(1 year)
- Karnofsky Performance Scale (KPS)(30 Days)
- Change in Gastric Outlet Obstruction Symptom Score (GOOSS)(1 year)
研究者
Petros Benias
Director of Endoscopic Surgery
Northwell Health