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Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study

Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05041608
Enrollment
5000
Registered
2021-09-13
Start date
2021-02-17
Completion date
2024-12-16
Last updated
2023-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed 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.

Interventions

PROCEDUREEndoscopic 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).

Sponsors

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Subjects undergoing Endoscopic Surgery

Exclusion criteria

* Subjects not undergoing Endoscopic Surgery

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of procedureUpto 1 yearTechnical and clinical success rate
Safety of procedureUpto 1 yearType, frequency and intensity of adverse events

Secondary

MeasureTime frameDescription
Quality of Life after procedureUpto 1 yearChart Review of quality-of-life improvement and overall survival duration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026