Symptoms and General Pathology

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Colonic Polyps

Polyps

Adenomatous Polyps

Adenoma

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Neoplasms by Histologic Type

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Pathological Conditions, Anatomical

Double balloon accessory device is used during the endoscopic polypectomy procedure

Double balloon accessory device

Peter Draganov, MD

This study is collecting standard of care information pertaining to the use of the accessory device and patient outcomes when this double balloon accessory device is used during endoscopic procedures in the colon.

Registry Evaluation of a Double Balloon Accessory Device

Multi-center Prospective Registry Study Utilizing a Double Balloon Accessory Device to Facilitate Endoscopic Polypectomy in Large Intestine.

Investigator rates the ease of use (easy, somewhat easy, somewhat difficult and difficult) of the device.

No moderate to severe mucosal injury, perforations or bleeding related to the use of the device.

Lumendi, LLC

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Respiratory Tract Infections

Cold forcep polypectomy performed for polyps \<=3mm.

Removal of appropriate polyps using cold forceps until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.

Cold forcep polypectomy

Removal of appropriate polyps using cold snare until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.

Cold snare polypectomy

Shai Friedland, MD

The focus of the study is to evaluate impact of cold forcep and cold snare in achieving complete resection during polypectomy of polyps \<=3mm during colonoscopy.

The details of the proposed study are as follows:

1. Experimental group: using cold forceps for polyps \<=3mm of the colon
2. Control group: using cold snare for polyps \<=3mm of the colon
3. Methods:

   1. Colonoscopy will be performed in the same standard of care manner as if no study was taking place.
   2. If polyps \<=3mm are identified, the endoscopist is randomized to performing polypectomy with cold forcep or cold snare.
   3. After removal of the polypectomy, two biopsies are performed at the margin of the polypectomy site to identify residual lesion.
   4. The polyp as well as well as the two biopsies are reviewed by a pathologist.

Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy

Randomized Controlled Trial Investigating Cold Snare aNd Forcep polypectomY Among Small POLYPs in Rates of Complete Resection: the TINYPOLYP Trial.

The primary outcome measured is comparison of completeness of resection between the cold forcep and cold snare groups.

The time between the forceps or snare is introduced till the polyp is removed and retrieved will be compared.

We will compare the number of bites or snare attempts needed to remove the tissue adequately to the endoscopist's judgment.

We will compare rates of complications including perforation and immediate post-polypectomy bleeding, early post-polypectomy bleed (within 24 hours) and delayed post polypectomy bleed (between 24 hours and 30 days). Early post-polypectomy bleed and delayed post-polypectomy bleed is evaluated based on emergency room (ER) visit, inpatient stay, transfusion needed, repeat colonoscopy required, surgical intervention required, and mortality.

Stanford University

Professor in Gastroenterology & Hepatology

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Herbal and Botanical

All Drugs and Chemicals

Cola

Eligible participants with a family history of colorectal cancer or polyps will be grouped into the "subjects" group.

Eligible participants without a family history of colorectal cancer or polyps will be grouped into the "control" group.

Philip Schoenfeld, MD

Conflicting guideline recommendations for screening colonoscopy result due to scant data upon which to develop appropriate recommendations. No previous study has compared the prevalence of advanced adenomas or adenomas (any size) among 40-49 year old individuals with a first degree relative (FDR) with colorectal cancer (CRC) versus 40-49 year old average risk individuals with no family history of CRC. The purpose of this study is to determine the prevalence of colon adenomas in 40-49 year old individuals and identify risk factors associated with the presence of advanced adenomas. This data will provide evidence to determine appropriate colon cancer screening guidelines in 40-49 year old persons with a family history of colon polyps or colorectal cancer.

Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer

Logistic regression will be used to determine if specific risk factors are associated with the risk of adenomas in 40-49 year old individuals. Data will be collected from patient surveys and medical records.

The outcome will be assessed after the completion of patient recruitment at all locations in August 2014. Advanced adenomas are defined as greater than or equal to 10 mm (1 cm). The presence of adenomas is determined be reviewing patient medical records and pathology reports.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

University of Michigan

Professor of Medicine

A standard of care colonoscopy will be done on the patient without extra time on the right side of the colon.

A standard of care colonoscopy will be done on the patient , however the time spent in the right side of the colon will be more than half of the normal colonoscopy procedure (i.e. more than 3 minutes)

Interventional group will have at least 3 minutes dedicated to the right side of the colon during segmental withdrawal.

Segmental withdrawal

Mohamed O. Othman, MD

Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for screening purposes to find any precancerous lesions (polyps) at an early stage. During the colonoscopy the doctor will advance the colonoscope to the end of your colon and start examining the colon for any polyps. "Withdrawal time" is the period of time the doctor spends examining the colon. Doctors usually spend six minutes examining the colon after they reach the end of the colon. Studies have showed that spending more withdrawal time detects more lesions. The proposal to dedicating half of the withdrawal time during colonoscopy in examining the right side will increase the detection of polyps in the right side of the colon. There will be no other changes in the procedural aspect of the colonoscopy.

Screening colonoscopy is an essential diagnostic tool in the early detection of precancerous colonic lesions, preventing the progression of these lesions to cancer. Population-based and case control studies found a 50% reduction in colo-rectal cancer (CRC) incidence and up to a one-third reduction in mortality from CRC after screening colonoscopy. The effectiveness of colonoscopy in preventing colon cancer is dependent on the adenoma detection rate (ADR) during the procedure. Studies have demonstrated that withdrawal times of 6 minutes or more had higher rates of detection of any neoplasia. In 2006 joint task force of the American College of Gastroenterology and American Society for Gastrointestinal Endoscopy changed the recommendation to indicate that average withdrawal time should exceed 6 minutes in normal colonoscopies in which no polypectomies or biopsies were performed. Based on this recommendation, the 6-minute benchmark is the current standard of care. Longer mean withdrawal times are associated with increasing adenoma detection, mainly of small or right-sided adenomas and proximal serrated adenomas, presumably due to longer inspection of the right colon. However, it also have been showed withdrawal time using 6 minutes as the threshold is not a strong predictor of the likelihood of finding a polyp during colonoscopy and should not be used as a quality indicator. New CRC diagnosis within 3 years of negative screening colonoscopy can be as high as 6%. Right-sided lesions, flat polyps, and variability in endoscopist quality measures are all potential reasons why interval cancers develop. A recent observational study was published showing increase in ADR after implementation of a protocol of careful inspection during a minimum of 8 minutes was established. The investigators hypothesized that if colonoscopists would spend at least half of the time of the withdrawal time in the right side of the colon (referred as segmented protocol), ADR can increase mainly due to the detection of lesions in the right side, which could have been missed otherwise. The investigators are conducting a single center randomized trial investigating the utility of timed segmental withdrawal of at least 3 minutes each in both right and left side of the colon respectively, compared to the regular 6 minutes total withdrawal time regardless of where the time was spent in the colon.

The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate.

The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate. A Randomized Controlled Clinical Trial.

To determine if timed segmental withdrawal protocol can increase the adenoma detection rate in the right side of the colon compared to non segmental withdrawal.

Compare sessile serrated lesion detection rate between patients undergoing a screening colonoscopy with segmental withdrawal protocol and non-segmental withdrawal protocol.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Registry Evaluation of a Double Balloon Accessory Device	NCT03942965	Adenomatous Pol...	Double balloon ...	18 Years -	Lumendi, LLC
Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy	NCT04551001	Colo-rectal Can... Polyp of Colon Adenomatous Pol...	Cold forcep pol... Cold snare poly...	18 Years -	Stanford University
Prevalence and Topography of Adenomas in 40-49 Year Old Patients With a Family History of Colon Cancer	NCT02289053	Colorectal Canc... Colon Polyps Adenomatous Pol...		40 Years - 49 Years	University of Michigan
The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate.	NCT02538406	Adenomatous Pol...	Segmental withd...	18 Years - 80 Years	Baylor College of Medicine
Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy	NCT04551001	Colo-rectal Can... Polyp of Colon Adenomatous Pol...	Cold forcep pol... Cold snare poly...	18 Years -	Stanford University
The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate.	NCT02538406	Adenomatous Pol...	Segmental withd...	18 Years - 80 Years	Baylor College of Medicine
Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy	NCT04551001	Colo-rectal Can... Polyp of Colon Adenomatous Pol...	Cold forcep pol... Cold snare poly...	18 Years -	Stanford University

Spots Global Cancer Trial Database for adenomatous polyp of colon