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

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

The patients with known prior diagnosis of histologically-confirmed Barrett's esophagus with or without dysplasia who have documentation of complete remission of Barrett's esophagus by endoscopy and histology after endoscopic ablation

Transoral Incisionless Fundoplication (TIF) is an endoscopic procedure that mechanically creates fundoplication similar to traditional operative Nissen fundoplication. The role of TIF in patients with BE whom underwent successful endoscopic ablation has not been fully investigated.

Saowanee Ngamruengphong

Barrett's esophagus (BE) is a precancerous lesion characterized by the replacement of the normal stratified squamous epithelium of the distal esophagus by intestinal metaplasia (IM). Non-dysplastic BE may progress to low-grade dysplasia (LGD), to high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC). Endoscopic ablation is safe and effective for complete eradication of BE. However, recurrence is common. Cumulative incidence rate of BE recurrence is up to 30% in the third year. Thus, achieving complete eradication of IM, patients should undergo surveillance indefinitely with serial endoscopy to assess for recurrence of BE. In addition, BE patients have been committed to life-long proton pump inhibitor (PPI) therapy, but increasing concerns about adverse effects has led to alternative therapies. Studies have showed that laparoscopic Nissen fundoplication may decrease recurrence of BE after endoscopic ablation. Transoral Incisionless Fundoplication (TIF) is an endoscopic procedure that mechanically creates fundoplication similar to traditional operative Nissen fundoplication. The role of TIF in patients with BE whom underwent successful endoscopic ablation has not been fully investigated.

Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus

Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus: A Pilot Study

Normal esophageal acid exposure time is 6 percent or less.

Percentage of participants that are able to discontinue PPI post TIF will be assessed at 6 months.

The presence of esophagitis on upper endoscopy.

Proportion of patients with recurrence of BE and BE-related dysplasia will be assessed up to 36 months.

Treatment related serious adverse events (SAEs) including hospitalization, unscheduled emergency room or physician visits for post-TIF symptoms), bloating, dysphagia.

The GERD-Health-related quality of life (HRQL) Questionnaire has an overall score range of 0 to 75. Each item is scored from 0 to 5, with a higher score indicating worse symptoms and poorer quality of life.

The RSI is a nine-item self-administered outcome questionnaire designed to document reflux symptoms and severity. Each item is scored on a scale of 0 (no problem) to 5 (severe problem), with overall score ranging between 0 and 45. Higher scores mean more severe symptoms. RSI \> 13 may be indicative of significant reflux disease.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus	NCT04457193	Barrett Esophag... Transoral Incis...	TIF	18 Years - 75 Years	Johns Hopkins University

Spots Global Cancer Trial Database for tif

Every month we try and update this database with for tif cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tif

Every month we try and update this database with for tif cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tif cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.