跳至主要内容
临床试验/NCT02637713
NCT02637713终止不适用

Radiofrequency Energy Delivery to the Lower Esophageal Sphincter (Stretta) in Sleeve Gastrectomy Patients With GERD

Montefiore Medical Center26 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
5
试验地点
26
主要终点
Number of Patients With Improved Symptoms Based on Reflux Symptom Index (RSI) Score

研究概览

简要总结

Gastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy. Management of GERD after sleeve is difficult given limited treatment modalities. Stretta is an endoscopic FDA approved device that improves symptoms of GERD, there is minimal information about its use on patients after sleeve. This registry will attempt to get information regarding the treatment of reflux using Stretta after sleeve gastrectomy.

详细描述

Gastroesophageal reflux disease (GERD) is a widely prevalent medical disorder in the United States with a spectrum of treatment options ranging from dietary modification, to various pharmacologic treatments, to an array of available surgical and endoscopic procedures. There is a well-described correlation between obesity and symptoms of GERD. The morbidly obese patients undergoing evaluation for bariatric surgery are to characterize any GERD-like symptoms as this will assist in directing surgical therapy. Generally, it is recommended that patients with severe GERD undergo Roux-en-Y gastric bypass(RYGB) rather than a sleeve gastrectomy (SG) as RYGB has proven to be the most effective surgical treatment for GERD in the morbidly obese patient. The number of bariatric procedures performed in the United States has increased significantly in the recent years. Out of all bariatric procedures SG is the most commonly performed in the United States, as it has proven to be a very safe procedure with excellent weight loss. However, the incidence of de novo GERD and the effect of SG on patients with preexisting GERD remain controversial. Although some authors report high incidence of de novo GERD and worsening of previous reflux symptoms, there is also data showing improvement of symptoms post SG. Management of GERD after SG poses an interesting challenge, as traditional invasive procedures like Nissen fundoplication are not available due to an altered gastric anatomy. The alternative is to perform a conversion to RYGB, which represents increased morbidity to patient and significant cost.

A large number of endoscopic procedures have been introduced in the past for the management of GERD as an alternative to the surgical anti-reflux procedures with various degrees of success. One of the few non-invasive methods for managing GERD that is still available on the market and widely used is Stretta. Stretta delivers Radio Frequency energy (RFe) to the LES resulting in increased LES pressure. In 2000, the FDA approved the Stretta system for treatment of GERD. Stretta allows an alternative for treatment in patients who are not willing or able to undergo surgery. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) published clinical practice guidelines that endorsed Stretta as an appropriate therapy for treatment of GERD in patients >18, with at least 6 months of symptoms partially or completely responsive to pharmacotherapy and who are unable or unwilling to undergo laparoscopic Nissen fundoplication. There are to date no studies evaluating the use of Stretta in management of patients with GERD symptoms after sleeve gastrectomy.

The investigators will study sleeve gastrectomy patients with GERD symptoms and if considered candidates for Stretta all patients will be enrolled in data collection cohort and followed prospectively with symptom questionnaire and quality of life scores for improvement of symptoms.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Symptomatic reflux: (heartburn, chest discomfort, asthma/chronic cough, laryngitis, nocturnal aspiration or regurgitation)
  • On a PPI with GERD-related symptoms
  • On a PPI but like to discontinue them

排除标准

  • Age <18 or > 80
  • History of a severe psychiatric disorder: including suicidal ideation, or admission to a psychiatric institution.
  • Unable or unwilling to consent for an invasive procedure.
  • History of intestinal leak after surgery.
  • History of revisional bariatric surgery
  • Significant sleeve abnormalities such and twist or large fundus
  • Hiatal hernia(>2cm)
  • Inability to comply with study protocols and procedures
  • Esophageal stricture, Eosinophilic Esophagitis or Achalasia
  • Prior esophageal surgery or therapy for Barrett's Esophagus
  • Grades 3 or 4 esophagitis
  • Gastric or esophageal varices
  • History of obstruction of the small bowel or inflammatory bowel disease
  • Pacemaker or implanted cardiac defibrillator
  • Coagulopathy or use of anticoagulants
  • ASA classification >3
  • Scleroderma or other connective diseases
  • Use of immunosuppressive medications.

结局指标

主要结局

Number of Patients With Improved Symptoms Based on Reflux Symptom Index (RSI) Score

时间窗: 6 months

RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.

Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score

时间窗: 24 months

RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem.

Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score

时间窗: 24 months

GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms.

次要结局

  • Gastric Emptying Study(Baseline (up to 4 hours))
  • Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy(12 months)
  • EGD Abnormalities(12 months)
  • Esophageal pH Levels(12 months)
  • Use of Anti-reflux Medication(Baseline)
  • Cessation or Decreased Use of Anti-reflux Medication(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (26)

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