Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study

NCT05041608 | Unknown

• 1 other identifier: Pro2020002798
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Achalasia; Gastric Outlet Obstruction; Gastroparesis; GERD; Reflux; Fistula; Benign Neoplasm

Keywords

POEM; ESD; STER; EFTR; EMR; NOTES; TIF; Capsule Endoscopy; Endoscopic suturing; Endoscopic Fistula Closure; ZPOEM; GPOEM

Outcome Measures

Primary Outcomes (2)

• Efficacy of procedure

  Technical and clinical success rate

  Upto 1 year

• Safety of procedure

  Type, frequency and intensity of adverse events

  Upto 1 year

Secondary Outcomes (1)

• Quality of Life after procedure

  Upto 1 year

Study Arms (1)

Subjects undergoing 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).

Procedure: Endoscopic Surgery

Interventions

Endoscopic Surgery PROCEDURE

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).

Subjects undergoing Endoscopic Surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing Endoscopic Surgery for various Gastrointestinal indications

You may qualify if:

• Subjects undergoing Endoscopic Surgery

You may not qualify if:

• Subjects not undergoing Endoscopic Surgery

Sponsors & Collaborators

• Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University: lead

Study Sites (1)

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (2)

• Shahid HM, Bareket R, Tyberg A, Sarkar A, Simon A, Gurram K, Gress FG, Bhenswala P, Chalikonda D, Loren DE, Kowalski TE, Kumar A, Vareedayah AA, Abhyankar PR, Parker K, Gabr MM, Nieto J, De Latour R, Zolotarevsky M 5th, Barber J, Zolotarevsky E, Vazquez-Sequeiros E, Gaidhane M, Andalib I, Kahaleh M. Comparing the Safety and Efficacy of Two Commercially Available Single-Use Duodenoscopes: A Multicenter Study. J Clin Gastroenterol. 2023 Sep 1;57(8):798-803. doi: 10.1097/MCG.0000000000001752.

  PMID: 35997700 DERIVED

• Shah-Khan SM, Zhao E, Tyberg A, Sarkar S, Shahid HM, Duarte-Chavez R, Gaidhane M, Kahaleh M. Endoscopic Ultrasound-Directed Transgastric ERCP (EDGE) Utilization of Trends Among Interventional Endoscopists. Dig Dis Sci. 2023 Apr;68(4):1167-1177. doi: 10.1007/s10620-022-07650-1. Epub 2022 Aug 10.

  PMID: 35947304 DERIVED

MeSH Terms

Conditions

Esophageal Achalasia; Gastric Outlet Obstruction; Gastroparesis; Gastroesophageal Reflux; Fistula; Neoplasms

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Michel Kahaleh, MD

  Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 13, 2021
• Study Start: February 17, 2021
• Primary Completion: December 16, 2023
• Study Completion: December 16, 2024
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)