NOVEL NON SURGICAL TREATMENT MODALITY FOR GASTRODUODENAL OUTLET OBSTRUCTION - RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1-Symptoms resolution ( heart burn, vomiting, abdomen pain and post prandial fullness)
研究概览
简要总结
Gastric outlet obstruction (GOO) includes obstruction in the antropyloric area or in the bulbar or post bulbar duodenal segments. Though malignancy remains a common cause of GOO in adults, a significant number of patients with GOO have benign causes. Among the latter are peptic ulcer disease, caustic ingestion, post-operative anastomotic state, drugs induced and inflammatory causes such as Crohn’s disease and tuberculosis.
Current management of benign GOO begins with conservative measures such as IV PPIs, sucralfate, cessation of NSAIDs use, treatment of H. pylori when applicable, and gastric decompression. Recent research has shown the use of endoscopic balloon dilation and medical therapy to be associated with favorable long-term outcomes and is considered to be first-line treatment of benign GOO but one-third of patients may ultimately require surgical intervention.
Still these strictures are difficult to manage conservatively and they usually require intervention to treat the stricture related complications. Although the surgical procedures are potentially curative, they are associated with high rates of morbidity and mortality.
Several non-surgical, minimally invasive options are available to treat benign strictures of the gastric outlet. These procedures, which can be performed endoscopically or fluoroscopically, include balloon dilation, temporary stent placement, intralesional steroid injection and incisional therapy with proton pump inhibitor. There is high prevelence of recurrence after treatment with PPI and CRE dilatation with unsatisfactory results.
Objective of the study- To assess the novel non surgical treatment modality for gastroduodenal ulcerative stricture
. Inclusion criteria -Patients aged more than 18 years, with benign gastroduodenal stricture related to NSAIDs, opiods, caustic and peptic.
Study methodology - Patients of benign ulcerated gastrotroduodenal stricture will be randomized (1:1) to PPI( Pantoprazole 40 mg BD) with CRE dilatation and misoprostol (400 mg TDS) plus pantoprazole 40 mg BD with CRE dilatation for 14 weeks.
Outcome **-**Symptoms resolution ( heart burn, vomiting, abdomen pain and post prandial fullness), Need for CRE dilatataion( number of CRE dilatation session), Need for surgery, Improvement in nutritional status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1- Patients aged more than 18 years 2- With benign gastroduodenal stricture related to NSAIDs, opiods, caustic and peptic.
排除标准
- •1- Previous poor compliance with pharmacologic treatment.
- •2- Refused to give consent for participation in study 3- Contraindication for misoprostol therapy 4- Patient with other causes of benign GOO such as chronic pancreatitis, Crohn’s and tuberculosis and fibrotic(healed) stricture will also excluded.
- •5- Patient who continue to take NSAIDs, opiods and smoke will also excluded.
结局指标
主要结局
1-Symptoms resolution ( heart burn, vomiting, abdomen pain and post prandial fullness)
时间窗: 14 weeks
2-Need for CRE dilatataion( number of CRE dilatation session)
时间窗: 14 weeks
3-Need for surgery
时间窗: 14 weeks
次要结局
- Improvement in nutritional status (Hemoglobin, serum albumin, bodyweight(14 weeks)