Digestive System Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Gastrointestinal Diseases

Gastroesophageal Reflux

Fistula

Gastroparesis

Esophageal Achalasia

Gastric Outlet Obstruction

Pyloric Stenosis

Constriction, Pathologic

Pathological Conditions, Anatomical

Stomach Diseases

Paralysis

Neurologic Manifestations

Idiopathic Achalasia

Cardiospasm

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

Michel Kahaleh, MD

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.

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.

Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study

Data will not be shared with other researchers.

Type, frequency and intensity of adverse events

Chart Review of quality-of-life improvement and overall survival duration

Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University

Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

This is a prospective registry of all patients who endoscopic submucosal dissection (ESD), per-oral endoscopic myotomy (POEM) and gastric per-oral endoscopic myotomy (G-POEM) using ConMed Electrosurgical unit for submucosal Dissection at Baylor St Luke's Medical Center. Collected information includes; procedure technical success rate, duration, periprocedural complications and ease of use.

Submucosal endoscopy is a novel subset of procedures which enables endoscopist to utilize the submucosal space to perform advanced endoscopic procedures. The submucosa is the third layer of the gastrointestinal wall and it is a potential space which is expandable upon injecting the submucosa with fluid. The expanded submucosa causes a significant lift which enable dissection of the submucosal space with the removal of the overlying polyp or early cancer. The submucosal space can be also utilized to create a longitudinal submucosal tunnel in the esophagus or the stomach wall which allows for performing lower esophageal sphincter or pyloric myotomy for the treatment of achalasia or Gastroparesis.

Currently, the most commonly performed submucosal endoscopy procedures are endoscopic submucosal dissection (ESD) for removal of early cancers or polyps throughout the gastrointestinal tract, Per-oral Endoscopic Myotomy (POEM) for treatment of achalasia, or Gastric Per-Oral Endoscopic myotomy for the treatment of Gastroparesis. All of the above procedures require a specialized electrosurgical unit (ESU) which generate high frequency current to help incision (cutting) of the mucosa and dissection (coagulation) of the submucosa. The ConMed Beamer is a novel ESU with tissue sensing property which expedites the process of submucosal dissection. The device is currently approved for clinical use in the US. The purpose of this study is to create registry for all submucosal endoscopy procedures performed using ConMed Beamer device at BSLMC with focus on clinical outcomes of the procedure including adverse events.

ConMed Beamer Study

Prospective Registry of Submucosal Endoscopic Procedures Performed by a Novel Electrosurgical Unit

This is a prospective single-center registry study.

Defined as the ability to perform the entire procedure using the ConMed Beamer electrosurgical system

Determine length of time to perform procedure using ConMed Beamer electrosurgical system

Intraprocedural AE such as bleeding or perforation

Post procedural, post polypectomy, delayed bleeding or delayed perforation

CONMED Corporation

Baylor College of Medicine

M.D. Director of Advanced Endoscopy Assistant Professor of Medicine - Gastroenterology Section

Diseases and Abnormalities at or Before Birth

Musculoskeletal Diseases

Hirschsprung Disease

Muscle Spasticity

Esophageal Diseases

Diverticulum

Diverticular Diseases

Zenker Diverticulum

Congenital Abnormalities

Digestive System Abnormalities

Megacolon

Colonic Diseases

Intestinal Diseases

Gastroenteritis

Diverticulum, Esophageal

To test the idea that submucosal endoscopy is effective and safe for endoscopic myotomy, endoscopic submucosal dissection, and access for tissue acquisition and resection. Submucosal endoscopy is a recent innovative addition to gastrointestinal endoscopy. This involves endoscopic maneuvers in the gut wall, by dissection of the submucosal layer of GI tract, thereby allowing endoscopic myotomy (incision of the muscle), endoscopic access for tissue acquisition and therapy, and resection of precancerous and cancerous gastrointestinal tissue. This approach has been a dramatic game-changer for minimally invasive management of various gastrointestinal conditions such as Zenker's diverticulum, Achalasia, Spastic Esophageal Disorders, Gastroparesis, esophageal obstruction, Hirschsprung's Disease, and Gastrointestinal neoplasia.

The aim of the proposed study is to prospectively assess technical success, clinical success, and adverse events after submucosal endoscopy. Technical success will be defined as ability to successfully complete the submucosal endoscopic procedure. Clinical success will be defined as symptom relief and objective evaluation which will be assessed with radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology results routinely performed post-procedure for clinical care, as indicated. Adverse events will be recorded per published ASGE criteria.

A database/ registry of patients undergoing submucosal endoscopic procedures will be created to demonstrate this.

Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy

Improvement in symptoms and objectively assessed by radiologic imaging, repeat endoscopy, gastrointestinal motility studies, and pathology.

Submucosal endoscopy technique and device used

University of Colorado, Denver

Esophageal Neoplasms

Esophageal Cancer

Rastislav Husťak, PhD, MD

Jan Martínek, MD

Jean-Michel Gonzalez, PhD

This is a retrospective study assessing the effectiveness of endoscopic pyloromyotomy in patients suffering from gastroparesis and/or symptoms of delayed gastric emptying after esophagectomy with gastric pull-through. Several, mainly European, centres which perform G-POEM on a routine basis will be asked to participate. The main reason to assess the effectiveness of G-POEM in this specific subgroup of patients is the fact this specific subgroup of patients is often being excluded from trials assessing efficacy and safety of G-POEM.

The participating centres will be asked to report appropriate patients among those who have undergone G-POEM since 2015 till December 2023. Patients fulfilling inclusion and not having exclusion criteria will be included into the analysis; the minimum follow-up is set to 6 months after G-POEM. The main outcome is the symptomatic response at 6, 12 and 24 months (measured by GCSI score). Other endpoints will be change in other symptoms not covered by GCSI, change in gastric emptying rate and safety of the procedure.

For each enrolled patient a case report form (CRF) will be filled in and delivered to the leading centre via an online database or in other forms if preferred by the respective centres. The leading centre will be responsible for data collection and analysis.

G-POEM for Refractory Gastroparesis After Esophagectomy With Gastric Pull-through

Retrospective Study of Per-oral Endoscopic Pyloromyotomy (G-POEM) in Patients With Refractory Gastroparesis After Esophagectomy With Gastric Pull-through

Gastroparesis Cardinal Symptom Index questionnaire: The score ranges from 0 to 5 for each symptom (9 questions) and these are averaged into subscores and into a total score (also ranging from 0 to 5). Higher scores indicate more severe symptoms.

Gastric scintigraphy protocol endorsed by both American Neurogastroenterology and Motility Society and American Nuclear Medicine Society will be used to assess gastric emptying with a standard 200 kcal, 2% fat egg-substitute test meal. Gamma camera images will be obtained immediately after meal ingestion and then at 1, 2, 3 and 4 hours. Diagnostic criterion for delayed gastric emptying is defined as the percentage of gastric retention \>60% at 2 h or ≥ 10% at 4 h or both. Half-time (T1/2) emptying time will also be calculated. At least 72 hours before gastric emptying test, narcotics and other medications that can interfere with gastric emptying will be discontinued.

Gastric emptying assessed using 13C breath test with octanoic acid. This measurement is an alternative to the measurement of gastric emptying by scintigraphy. The choice depends on the practice in a particular center.

Pyloric distensibility measured by impedance planimetry (EndoFLIP device)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study	NCT05041608	Achalasia Gastric Outlet ... Gastroparesis GERD Reflux Fistula Benign Neoplasm	Endoscopic Surg...	-	Advanced Endoscopy Research, Robert Wood Johnson Medical School Rutgers University
ConMed Beamer Study	NCT04752670	Gastrointestina... Achalasia Gastroparesis		18 Years -	Baylor College of Medicine
Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy	NCT03626350	Gastrointestina... Hirschsprung's ... Esophageal Obst... Gastroparesis Spastic Esophag... Zenker's Divert...		18 Years - 89 Years	University of Colorado, Denver
G-POEM for Refractory Gastroparesis After Esophagectomy With Gastric Pull-through	NCT06068127	Gastroparesis Esophageal Canc...		18 Years -	Institute for Clinical and Experimental Medicine
Prospective Evaluation of the Efficacy and Safety of Submucosal Endoscopy	NCT03626350	Gastrointestina... Hirschsprung's ... Esophageal Obst... Gastroparesis Spastic Esophag... Zenker's Divert...		18 Years - 89 Years	University of Colorado, Denver

Spots Global Cancer Trial Database for gastroparesis