NCT05041608

Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study

Status unknown Last updated 26 May 2023

What this trial tests

trial testing Endoscopic Surgery in Achalasia in 5,000 participants. Status unknown.

Timeline

17 February 2021

Primary endpoint
16 December 2023

16 December 2024

Quick facts

Lead sponsor	Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	5,000
Start date	17 February 2021
Primary completion	16 December 2023
Estimated completion	16 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Endoscopic Surgery

Conditions studied

• Achalasia — all drugs for Achalasia →
• Gastric Outlet Obstruction — all drugs for Gastric Outlet Obstruction →
• Gastroparesis — all drugs for Gastroparesis →
• GERD — all drugs for GERD →

Sponsor

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

Who can join

Eligibility, any sex, with Achalasia or Gastric Outlet Obstruction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Endoscopic ultrasound-directed transgastric ERCP (EDGE): A multicenter US study on long-term follow-up and fistula closure.
   Kedia P, Shah-Khan S, Tyberg A, Gaidhane M, et al · · 2023 · cited 25× · PMID 37251793 · DOI 10.1055/a-2057-5984
2. EUS-guided <i>versus</i> percutaneous liver abscess drainage: A multicenter collaborative study.
   Shahid H, Tyberg A, Sarkar A, Gaidhane M, et al · · 2023 · cited 9× · PMID 38948125 · DOI 10.1097/eus.0000000000000033
3. Endoscopic Ultrasound-Directed Transgastric ERCP (EDGE) Utilization of Trends Among Interventional Endoscopists.
   Shah-Khan SM, Zhao E, Tyberg A, Sarkar S, et al · · 2023 · cited 4× · PMID 35947304 · DOI 10.1007/s10620-022-07650-1
4. Safety and efficacy of peroral endoscopic myotomy with endoscopic fundoplication compared with POEM alone: International multicenter cohort study.
   Kahaleh M, Hapshy V, Alcívar JA, Baquerizo-Burgos J, et al · · 2025 · PMID 40860698 · DOI 10.1055/a-2655-6550