Outcome Analysis of POEM and Endoluminal Therapies

Not Applicable

• Conditions: Gastric Fistula; Achalasia; Stenoses; Weight Gain After Primary Weight Loss Surgery; Gastric Nec; Marginal Ulcer
• Interventions: Procedure: Endoscopic Intervention

• Registration Number: NCT03123835
• Lead Sponsor: University of California, Davis

Brief Summary

Evaluation of current and newly developed endoluminal therapies in the management of Upper and Lower GI conditions.

Detailed Description

Over the last few years there have been numerous advances in the use of endoscopic equipment and related treatments in the identification and intervention of gastrointestinal diseases. Many of these treatments using flexible endoscopes have either complimented or replaced surgical approaches to these same benign and malignant disease processes with the potential of being the standard of care for many of these clinical conditions. The initial primary focus of this study will be the use of endoscopic myotomy for achalasia, endoscopic treatment of post bariatric weight gain, endoscopic gastro-gastric fistula treatments, and other endoluminal therapies for gastrointestinal and post-operative conditions. These treatments have been validated by prior surgery studies.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12
• Primary Completion: 2030-12
• Study Completion: 2031-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Adult male and female patients 18-80 years of age
• Meet the criteria for surgery of benign and/or malignant gastrointestinal pathology(s)
• Gastrointestinal Reflux Disease
• Achalasia
• Barrett's Esophagus
• Post Bariatric Surgery conditions
• Other gastrointestinal and postsurgical disorders.

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Exclusion Criteria

• Adults unable to consent
• Individuals that do not meet inclusion criteria or qualify for endoluminal treatment paradigms and internees.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Endoscopic Intervention	Patients meeting inclusion criteria for possible surgical therapies for their current condition (IE Achelasia, Enlarged Gastric Pouch and/or Gastrogastric Fistula after primary weight loss surgery, etc) will be educated on the different therapy options including traditional laparoscopic surgery and/or Endoscopic Interventions including POEM (Percutaneous Oral Endoscopic Myomectomy for the treatment of Achelasia) or Endoscoscopic Pouch/GastroJejunostomy repair or closure of the Gastrogastric Fistula as examples.

Primary Outcome Measures

Name	Time	Method
Decrease in GERDDQ	3-6 months	Assessment will be made via post surgery questionnaire (decreasing in scoring will be 0-5)

Secondary Outcome Measures

Name	Time	Method
Decrease in Eckardt scoring	30 days	Decrease in overall GERD symptoms using Eckardt Scoring methodology (5-0)

Trial Locations

Locations (1)

Univesity of California Davis Health System; 🇺🇸 Sacramento, California, United States