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

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Syndrome

Intestinal Neoplasms

Colorectal Neoplasms

Colorectal Neoplasms, Hereditary Nonpolyposis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neoplastic Syndromes, Hereditary

Colonic Diseases

Intestinal Diseases

Genetic Diseases, Inborn

DNA Repair-Deficiency Disorders

Metabolic Diseases

Small Intestine Cancer

capsule endoscopie at baseline and after 2 years

Capsule endoscopy at baseline and after 2 years

Capsule endoscopy

Jan J Koornstra, MD PhD

Jan H Kleibeuker, MD PhD

Hans F Vasen, MD PhD

Lynch syndrome (LS), or hereditary nonpolyposis colorectal cancer (HNPCC), is a hereditary disorder characterized by a very high risk of early-onset colorectal and endometrial cancer and an increased risk of other cancers, including cancers of the stomach, ovary, urinary tract, hepatobiliary tract, pancreas and small bowel. This is a national multi-centre study evaluating the yield of small bowel screening using capsule endoscopy (CE) and double balloon enteroscopy (DBE) in Lynch syndrome subjects. The intervention consists of performing a capsule endoscopy procedure at baseline and at 2-year follow-up. In patients with polyps or malignant appearing abnormalities on capsule endoscopy, double balloon enteroscopy will be performed with subsequent endoscopic or surgical removal of neoplastic lesions. The aim of the study is to determine the prevalence and incidence of small bowel neoplasia in Lynch syndrome patients using small bowel CE and DBE.

Lynch syndrome (LS), or hereditary nonpolyposis colorectal cancer (HNPCC), is an autosomal dominantly inherited disorder characterized by a very high risk of early-onset colorectal and endometrial cancer and an increased risk of other cancers, including cancers of the stomach, ovary, urinary tract, hepatobiliary tract, pancreas and small bowel. LS is caused by germline mutations in one of the mismatch repair (MMR) genes, mostly hMLH1, hMSH2 and hMSH6. Recently, several studies, including one from the Netherlands, have evaluated the life-time risk of small bowel cancer (SBC) in LS patients. From these studies the life-time risk of SBC is estimated around 4%. This is similar to the life-time risk of colorectal cancer in the general population, for which screening is generally advised. The risk of SBC increases with age, with an estimated prevalence of 1:500 at the age of 40, rising to an estimated prevalence of around 1:70 at the age of 60. Compared with the general population, LS patients with SBC generally present 10-20 years earlier as most patients with sporadic SBC are in their sixth or seventh decade of life. The localisation of SBC in LS is almost equal in the duodenum and jejunum, with localisation in the ileum generally occurring at a lower frequency.Until now, screening for small bowel neoplasia in Lynch syndrome patients is generally not recommended. However, the development of two new techniques to visualize the small intestine has raised the question whether screening might be useful and advisable. Small bowel capsule endoscopy (CE) has been developed as a safe, patient-friendly, minimally invasive modality for visualization of the small bowel. In addition, double-balloon enteroscopy (DBE) has been developed, a technique which allows endotherapeutic interventions. The diagnostic yields of both techniques are markedly higher than the conventional methods, such as push-enteroscopy and enteroclysis. To date, no study has been performed on screening for small bowel neoplasia in Lynch syndrome patients by means of these techniques.

The primary aim of the study is to determine the prevalence and incidence of small bowel neoplasia in Lynch syndrome patients using small bowel CE and DBE.

Secondary objectives:

The secondary aim is to identify risk factors for small bowel pathology useful in clinical practice to identify patients that might benefit from screening and to determine the additional interventional risk associated with the endoscopic procedures.

This is a national multi-centre study evaluating the yield of small bowel screening using capsule endoscopy and double balloon enteroscopy in Lynch syndrome subjects. The intervention consists of performing a capsule endoscopy procedure at baseline and at 2-year follow-up. In patients with polyps or malignant appearing abnormalities on capsule endoscopy, double balloon enteroscopy will be performed with subsequent endoscopic or surgical removal of neoplastic lesions.

Capsule Endoscopy to Screen for Small Bowel Neoplasia in Lynch Syndrome

Capsule Endoscopy in Lynch Syndrome for Small Intestinal Tumor Screening

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Erasmus Medical Center

Leiden University Medical Center

St. Antonius Hospital

The Netherlands Cancer Institute

University Medical Center Nijmegen

Maastricht University Medical Center

Free University Medical Center

Medtronic - MITG

University Medical Center Groningen

Esophageal Neoplasms

Stomach Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Stomach Cancer

subjects involved in medical consortium for screening upper gastrointestinal canccers(MCSC)

subjects received intensive follow-up by coordinators according to the predifined protocol of MCSC

Medical Consortium

Yanqing Li, PhD, MD

Yanqing Li, PHD

The aim of our study was to demonstrate the efficacy and feasibility of the medical consortium for screening upper gastrointestinal cancers with magnetically controlled capsule gastroscopy.

In this study, the investigators designed a propective cohort study to evaluate the the efficacy and feasibility of medical consortium for screening upper gastrointestinal cancers (MCSC) with magnetically controlled capsule gastroscopy (MCCG).

Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy

Yanqing Li

vice president of Qilu Hospital

Crohn Disease

Diarrhea

Celiac Disease

Inflammatory Bowel Diseases

Gastroenteritis

Signs and Symptoms, Digestive

Malabsorption Syndromes

Chronic Graft Versus Host Disease

Xavier DRAY, MD PhD

Romain LEENHARDT, MD

Patients participating to this study will provide images and videos of capsule endoscopy to train, tune and evaluate technological bricks of artificial intelligence solutions, in order to improve diagnostic performances of the procedure, while reducing reading time by physicians.

Capsule endoscopy is a minimally-invasive diagnostic procedure based on the ingestion (or endoscopic delivery) of a miniaturized biocompatible, camera. Capsules capture tenths of thousands images of the digestive tract. Reading the captured images and reporting is long, tedious, and at risk of errors when the reader's attention is disturbed. Artificial intelligence is expected to alleviate these limitations, by both improving diagnostic performances of capsule endoscopy while reducing reading time.

Any patient in whom a capsule endoscopy examination is performed as part of routine care will be invited to participate to the study. Their de-identified images and videos will be extracted, thus allowing the creation of several databases for training, tuning and testing technological bricks of artificial intelligence. Basic clinical data will be collected (age, gender, indication for capsule endoscopy, type of device, ingestion or delivery of capsule). Images and videos will be characterized centrally and consensually by a panel of 3 expert readers, according to their level of relevance in relation to the type and indication of capsule endoscopy.

The various, developed technological bricks will aim to automatically detect and characterize anatomical landmarks and abnormal findings, and to quote the intestine cleanliness.

Assessment of diagnostic performance and reading time will be performed within a few months or up to five years, for each technological brick, individually and then combined, according to their stepwise development.

Development of New Diagnostic Tools in Capsule Endoscopy

Sensitivity in detection of lesions of intermediate to high relevance as identified centrally and consensually by a panel of 3 expert readers (AI vs standard reading)

Other diagnostic performance (specificity, positive and negative predictive values, accuracy) in detection of lesions of intermediate to high relevance as identified centrally and consensually by a panel of 3 expert readers (AI vs standard reading)

Time needed for detection of lesions of intermediate to high relevance as identified centrally and consensually by a panel of 3 expert readers (AI vs standard reading)

Diagnostic performances in positioning anatomical landmarks (1st gastric, small bowl and colonic images) as identified centrally and consensually by a panel of 3 expert readers (AI vs standard reading)

Diagnostic performances in quoting small bowel and colonic quality of preparation, as compared toed centrally and consensually quoted by a panel of 3 expert readers

Assistance Publique - Hôpitaux de Paris

Polyps

Rectal Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Infective Agents

Gastrointestinal Agents

Antiemetics

Cardiotonic Agents

Herbal and Botanical

Erythromycin

Erythromycin Estolate

Erythromycin Ethylsuccinate

Erythromycin stearate

Metoclopramide

Bisacodyl

Sennosides

Dopamine

Dopamine Antagonists

Dopamine Agents

Neurotransmitter Agents

Anti-Bacterial Agents

Enzyme Inhibitors

Laxatives

Cathartics

Cola

Senna

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-CONTROL

Senna tablets

SUPREP oral sulfate solution

SUPREP oral sulfate solution with Gastrografin

Douglas K Rex, Dr.

This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON 2 Capsule Endoscopy System (CCE) procedures in average risk patients.

Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam CCE.

This is a multicenter, prospective, consecutive, randomized study. Average-risk subjects undergoing CCE without optical colonoscopy will be consecutively enrolled and randomized 1:1 to receive one of two bowel preparation regimens prior to PillCam CCE.

Subjects will be enrolled at 5-10 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit and will be evaluated on the procedure day or until capsule excretion. A telephone follow-up will be conducted 5 to 9 days post-capsule ingestion to verify capsule excretion, assess patient well-being, and capture any adverse events.

Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure

COVGIC20482: A Multicenter, Consecutive, Randomized Study to Optimize the Bowel Preparation Regimen for the PillCam COLON 2 Capsule Endoscopy Procedure

The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).

Will be assessed from RAPID video in total and by segment

Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment

Will be assesses by applicable case report form (CRF)

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Control

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Bowel Preparation Regimen -Control

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

Bowel Preparation Regimen-Test

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-CONTROL

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Liron Bar Yaakov

Overall Excellent cleansing

Cecum Excellent cleansing

Ascending Excellent cleansing

Transverse Excellent cleansing

Descending Excellent cleansing

Rectum Excellent cleansing

Overall Good cleansing

Cecum Good cleansing

Ascending Good cleansing

Transverse Good cleansing

Descending Good cleansing

Rectum Good cleansing

Overall Fair cleansing

Cecum Fair cleansing

Ascending Fair cleansing

Transverse Fair cleansing

Descending Fair cleansing

Rectum Fair cleansing

Overall Poor cleansing

Cecum Poor cleansing

Ascending Poor cleansing

Transverse Poor cleansing

Descending Poor cleansing

Rectum Poor cleansing

this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon.

Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)

Overall (any size)

Cecum (any size)

Ascending (any size)

Transverse (any size)

Descending (any size)

rectum (any size)

Overall (polyps ≥6mm)

Cecum (polyps ≥6mm)

Ascending (polyps ≥6mm)

Transverse (polyps ≥6mm)

Descending (polyps ≥6mm)

Rectum (polyps ≥6mm)

Overall (polyps ≥10mm)

Cecum Overall (polyps ≥10mm)

Ascending Overall (polyps ≥10mm)

Transverse (polyps ≥10mm)

Descending (polyps ≥10mm)

Rectum (polyps ≥10mm)

This analysis is a subset of the PPAs excluding patients with one or more missing video data for Cecum, Ascending and transverse colon. Patients with at least one polyp detected on overall segments.

Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE

Bowel Preparation Regimen - Control

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure- Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

The following patients were excluded from the analysis:2 withdrawn patients, 1 LTF (Lost to follow-up) patient, 2 pattients with failed prcedure, 16 patients with incomplete COLON exam.

Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE

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
Capsule Endoscopy to Screen for Small Bowel Neoplasia in Lynch Syndrome	NCT00898768	Lynch Syndrome Small Bowel Neo...	Capsule endosco...	35 Years - 70 Years	University Medical Center Groningen
Medical Consortium for Screening Upper Gastrointestinal Cancers With Magnetically Controlled Capsule Gastroscopy	NCT04032353	Capsule Endosco... Cancer of Stoma... Cancer of Esoph... Health Policy	Medical Consort...	18 Years - 80 Years	Shandong University
Development of New Diagnostic Tools in Capsule Endoscopy	NCT06152289	Bowel Disease Crohn Disease Celiac Disease Chronic Diarrhe... Tumor		-	Assistance Publique - Hôpitaux de Paris
Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure	NCT02481219	Colorectal Canc...	PillCam® COLON ... Senna tablets PEG Metoclopramide Erythromycin SUPREP oral sul... Bisacodyl SUPREP oral sul...	50 Years - 75 Years	Medtronic - MITG
Development of New Diagnostic Tools in Capsule Endoscopy	NCT06152289	Bowel Disease Crohn Disease Celiac Disease Chronic Diarrhe... Tumor		-	Assistance Publique - Hôpitaux de Paris
Small Bowel Capsule Endoscopy: Experience From a Single Large Tertiary Care Centre	NCT05228379	Small Bowel Dis... Small Bowel Ulc... Capsule Endosco... Small Bowel Tum...	Small Bowel Cap...	6 Years - 87 Years	Asian Institute of Gastroenterology, India

Spots Global Cancer Trial Database for capsule endoscopy