Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study
NCT ID: NCT05041608
Last Updated: 2023-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
5000 participants
OBSERVATIONAL
2021-02-17
2024-12-16
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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).
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
OTHER
Responsible Party
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Principal Investigators
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Michel Kahaleh, MD
Role: PRINCIPAL_INVESTIGATOR
Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
Locations
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Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
New Brunswick, New Jersey, United States
Countries
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References
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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.
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.
Other Identifiers
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Pro2020002798
Identifier Type: -
Identifier Source: org_study_id
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