Outcome Analysis of POEM and Endoluminal Therapies

Sponsor

University of California, Davis (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03123835

Collaborator

(none)

500

Enrollment

Location

Arm

153

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Achalasia Gastric Fistula Weight Gain After Primary Weight Loss Surgery Marginal Ulcer Stenoses Gastric Nec	Procedure: Endoscopic Intervention	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Outcome Analysis of Endoluminal Therapies for Gastrointestinal Conditions Compared to Current Treatment Paradigms

Study Start Date :

Mar 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Other: Treatment 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.	Procedure: Endoscopic Intervention After reviewing all therapeutic options the patient will be offered the best therapeutic option to treat their condition. Surgical interventions include open laparotomy, diagnostic/therapeutic laparoscopy or endoluminal therapies. After the patient is consented for the related surgical intervention the patient will be given the option to participate in the clinical study to measure outcomes after surgery. Other Names: Endoluminal Therapies, POEM, Endoscopic Revision

Arm

Intervention/Treatment

Other: Treatment

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.

Procedure: Endoscopic Intervention

After reviewing all therapeutic options the patient will be offered the best therapeutic option to treat their condition. Surgical interventions include open laparotomy, diagnostic/therapeutic laparoscopy or endoluminal therapies. After the patient is consented for the related surgical intervention the patient will be given the option to participate in the clinical study to measure outcomes after surgery.

Other Names:

Endoluminal Therapies, POEM, Endoscopic Revision

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Decrease in Eckardt scoring [30 days]
Decrease in overall GERD symptoms using Eckardt Scoring methodology (5-0)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.