Clinical trial NCT05041608: Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study
Official title: Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing Endoscopic Surgery for various Gastrointestinal indications

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.

Eligibility criteria: Inclusion Criteria:

* Subjects undergoing Endoscopic Surgery

Exclusion Criteria:

* Subjects not undergoing Endoscopic Surgery

Primary outcomes:
measure: Efficacy of procedure
timeFrame: Upto 1 year
measure: Safety of procedure
timeFrame: Upto 1 year
Secondary outcomes:
measure: Quality of Life after procedure
timeFrame: Upto 1 year
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
state: New Jersey
Study officials:
affiliation: Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
name: Michel Kahaleh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.