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NCT05041608 Clinical Trial

Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study

GERD Clinical Trial

Official title:
Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05041608
Other study ID # Pro2020002798
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date February 17, 2021
Est. completion date December 16, 2024

Study information
Verified date May 2023
Source Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations. Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS. The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.

Description:

Our tertiary-care institution performs clinically-indicated various Endoscopic Surgery procedures gastrointestinal indications in more than 800-1000 patients annually. The study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as POEM (Peroral Endoscopic Myotomy), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection). Clinical metrics will be collected including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time. Various endoscopic surgical procedures are less invasive than traditional surgery, have fewer side effects and provide better efficacy. Moreover, they can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention. They improve quality of life and extend survival duration. Endoscopic surgery procedures can be an appropriate approach in many gastrointestinal disorders including early neoplasms, challenging adenomas or sub-epithelial lesions that requires the resection of the superficial layers, mucosa and submucosa, or full thickness resection of the tract wall. Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations. Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS. The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 5000
Est. completion date December 16, 2024
Est. primary completion date December 16, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Subjects undergoing Endoscopic Surgery Exclusion Criteria: - Subjects not undergoing Endoscopic Surgery

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endoscopic Surgery
These procedures include: POEM (Peroral Endoscopic Myotomy) for Achalasia, G-POEM (Gastric Peroral Endoscopic Myotomy) for gastric outlet obstruction, Z-POEM (Peroral endoscopic myotomy for Zenker's Diverticulum), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection).

Locations
Country Name City State
United States Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University New Brunswick New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of procedure Technical and clinical success rate Upto 1 year
Primary Safety of procedure Type, frequency and intensity of adverse events Upto 1 year
Secondary Quality of Life after procedure Chart Review of quality-of-life improvement and overall survival duration Upto 1 year
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