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Colonic Polyps

Polyps

Pathological Conditions, Anatomical

Intestinal Polyps

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Cola

this instrument provides extra confidence for in vivo diagnosis through improved vessel and mucosal pattern characterization.

iScan

Daniel von Renteln, MD, PhD

Eliminating the need for conventional histopathological assessment of diminutive colon polyps - The Non-Optical Resect and Discard (NORD) study

Implementation of this approach by community-based gastroenterologists has failed to reach the required quality benchmarks and studies evaluating optical biopsy have not shown diagnostic test performance results that meet standards set by society guidelines in order to promote its widespread clinical adoption. Optical polyp diagnosis and the current resect and discard approach are too complex for clinical adoption. Thus, clinical implementation of this valuable concept has not been achieved to date and its cost-saving potential has not been realized. In order to effectively operationalize a resect and discard strategy, one must find a different way to distinguish neoplastic from non-neoplastic polyps. There exist differences in the proportion of polyps found to be adenomatous in the left and right colon. One recent study reported that 30% of left-sided polyps and 76% of right-sided polyps were found to be adenomas on histology. Since polyps located in the proximal colon are more likely to be adenomas and polyps in the recto-sigmoid colon are more likely hyperplastic we hypothesized that a model based on polyp location might be able to replace optical biopsy and histopathology. Such an approach would be very simple to adopt by every clinician and would allow for easy adoption into clinical practice.

The Non-Optical Resect and Discard Study (NORD)

Eliminating the Need for Conventional Histopathological Assessment of Diminutive Colon Polyps - The Non-Optical Resect and Discard Study (NORD)

Our aim is to examine and to make a comparison of these models with the currently endorsed resect and discard approach that is based on optical polyp diagnosis and we will also obtain histopathology for all polyps as a reference gold-standard to which all models are compared.

Assess for how many patients each model will theoretically reduce the need for histopathologic assessment and follow-up consultations to discuss pathology results and surveillance interval recommendations

We will assess this in conjunction with different digital chromoendoscopy methods (NBI, iScan and Optivista) and assess concordance between these imaging methods and classification systems to differentiate neoplastic from non-neoplastic polyps.

Assess which factors are associated with accuracy and negative predictive value (NPV) of optical polyp diagnosis

Surveillance interval agreement of the PBRD strategy compared with pathology-based management according to the 2020 USMSTF guidelines.

Centre hospitalier de l'Université de Montréal (CHUM)

Neoplasms

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Adenoma

Respiratory Tract Infections

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques.

Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques.

Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques.

Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques.

Subjects randomized to Cold Snare Intervention will have any polyps sized 6mm to 15mm removed using cold snare techniques (no electrocautery, no submucosal injection.)

Cold Snare

Subjects randomized to Hot Snare Intervention will have any polyps sized 6mm to 15mm removed using hot snare techniques (with electrocautery, no submucosal injection.)

Hot Snare

Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.)

Cold EMR

Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.)

Hot EMR

Douglas K Rex, MD

The study will compare the use of cold snare, hot snare, cold EMR, and hot EMR for polyp resection. Although previous studies have compared two of the potential resection methods, no previous study has evaluated all four of the resection methods.

The optimal method for removal of polyps 6-9 and 10-15 mm in size is not established. In this study, we propose to evaluate four different treatments for polyps (sized 6mm-15mm). The four treatments are cold snaring without injection, hot snaring without injection, cold EMR, and hot EMR. This study aims to help to establish the optimal resection technique for 6-9 and 10-15 mm polyps.

Quad Resection (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)

A Randomized Trial Comparing the Effectiveness of Polyp Resection Treatments (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)

De-identified data may be shared in the future upon request per PI discretion.

Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the central post-resection biopsies. Positive means that there was residual polyp tissue seen on the central post-resection biopsies. Negative central post-resection biopsies are considered a better outcome.

Efficacy of resection will be assessed by biopsies in four quadrants of the perimeter of the defect post-resection and one biopsy from the center of the defect post-resection. Comparison of the biopsy pathology results for polyps removed by cold snare vs. hot snare vs. cold EMR vs. hot EMR. Negative means that there was no residual polyp tissue seen on the peripheral post-resection biopsies. Positive means that there was residual polyp tissue seen on the peripheral post-resection biopsies. Negative peripheral post-resection biopsies are considered a better outcome.

John D. Dingell VA Medical Center

White River Junction Veterans Affairs Medical Center

Indiana University

Professor of Medicine

Patients were called approximately 30 days after their colonoscopy procedure.

Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold snare techniques.

Cold Snare: Subjects randomized to Cold Snare Intervention will have any polyps sized 6mm to 15mm removed using cold snare techniques (no electrocautery, no submucosal injection.)

Polyps sized 6mm to 15mm found during colonoscopy will be removed using cold EMR techniques.

Cold EMR: Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.)

Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot snare techniques.

Hot Snare: Subjects randomized to Hot Snare Intervention will have any polyps sized 6mm to 15mm removed using hot snare techniques (with electrocautery, no submucosal injection.)

Polyps sized 6mm to 15mm found during colonoscopy will be removed using hot EMR techniques.

Hot EMR: Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.)

Total

Age, Continuous

Sex: Female, Male

Black or African American

White

Other/Unknown

Race/Ethnicity, Customized

Number of Polyps

Diagnostic

Screening

Surveillance

Therapeutic

Indication

Detroit Veterans Affairs Medical Center

Site

Study endoscopists are experts with special interest in polypectomy; serrated lesions were included in the study instead of only including adenomas; incomplete resections occurred in 10-15mm lesions so a study designed for 10-15mm or 10-20mm lesions may be more relevant; potential of proceduralist bias due to lack of endoscopist blinding; relying on biopsies of the defect instead of evaluation of scars at surveillance for determining efficacy

Clinical Research Specialist

Negative

Positive

Efficacy of Resection (Central Post-Resection Biopsies)

Efficacy of Resection (Peripheral Post-Resection Biopsies)

Overall Study

Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode.

Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode.

No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode.

No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode.

Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.

Clip closure

Heiko Pohl

The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) using electrocautery snares. Resection of these large polyps is associated with a risk of severe complications that may require hospitalization and additional interventions. The most common risk is delayed bleeding which is observed in approximately 2-9% of patients. A recent retrospective study suggests that closure of the large mucosal defect after resection may decrease the risk of delayed bleeding. However, significant uncertainty remains about the polypectomy techniques to optimizing resection and minimizing risk. Important aspects that may affect risk include clipping of the mucosal defect and electrocautery setting.

Aim 1. The primary aim of the study is to compare the rate of delayed bleeding complications in patients undergoing endoscopic resection of large polyps between:

* A) Closing the mucosal defect after resection (Clip group) and
* B) Not closing the mucosal defect after resection (No clip group).

Aim 2. The secondary aim of the study is to compare the rate of overall complications in patients undergoing endoscopic resection of large polyps between two cautery settings:

* A) Low power coagulation and
* B) Endocut.

Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

Factors that may be associated with complications, including electrocautery setting, polyp size, location of the polyp in the colon (right, left, rectum), histology, polyp morphology, time required for resection.

Factors that may be associated with incomplete resection may include prior attempts of removal, use of adjunctive argon plasma coagulation for residual polyp removal, polyp size, location, histology.

A bleeding event that occurred within 30 days after completion of the colonoscopy with a study polyp resection and is associated with a decrease in hemoglobin by at least 2gm, hemodynamic instability, presentation to the ED, need for hospitalization, repeat colonoscopy, or other interventions.

Overall complications are defined as an aggregate of all complications that occur at the time of the procedure (immediate complications) or during 30 days of follow-up. They include delayed bleeding complications, perforation, postpolypectomy syndrome, and clinical events that require an ED visit, admission to the hospital, additional testing or an intervention.

Rate of complete study polyp resection at the initial colonoscopy and at first follow-up endoscopy

Rate of recurrent polyp at the resection site after complete polyp resection.

Incidence of complications associated with application of clips.

Dartmouth College

Boston Scientific Corporation

Principal Investigator

Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.

Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode.

Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.

Clip Closure + EndoCut

Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode.

Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.

Clip Closure + Coagulation

No Clip Closure + EndoCut

No Clip Closure + Coagulation

Race (NIH/OMB)

Body Mass Index (BMI)

The American Society of Anesthesiologist (ASA) Classification is a grading system to assess a patient's fitness before undergoing a surgical procedure.

ASA Class

Periprocedural Antithrombic Medications

Procedure Sedation

Quality of Bowel Preparation

Electrocautery

Additional Polyps (any size)

More Than One Study Polyp

Complete defect closure not possible in 13% of patients. Crossover to clip group in 10% of patients.

Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode or the Coagulation electrocautery mode.

Clip closure: Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.

Clip Closure

No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode or the Coagulation electrocautery mode.

No Clip Closure

As per study protocol, the primary analysis was done using clip/no clip closure as the study groups. Data for 9 patients was not available.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Non-Optical Resect and Discard Study (NORD)	NCT04032912	Polyp of Colon	iScan	45 Years - 80 Years	Centre hospitalier de l'Université de Montréal (CHUM)
Quad Resection (Hot Snare vs Cold Snare vs Hot EMR vs Cold EMR)	NCT03462706	Colon Cancer Colon Polyp Colon Adenoma	Cold Snare Hot Snare Cold EMR Hot EMR	40 Years -	Indiana University
Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.	NCT01936948	Colon Polyps	Clip closure	18 Years - 89 Years	White River Junction Veterans Affairs Medical Center

Spots Global Cancer Trial Database for polyp resection