Clinical Trials Logo

Clinical Trial Summary

Complete resection of neoplastic polyps is pivotal, as 8.8% to 50% of interval cancers may arise as a consequence of incomplete polypectomy. However, the ideal method to remove small colorectal polyps remains uncertain. The investigators designed a randomized controlled trial to assess whether injection-assisted cold snare polypectomy may be noninferior to EMR for the resection of small (6-10mm) colorectal polyps.


Clinical Trial Description

Polypectomy is the basis of colorectal cancer prevention by interrupting the adenoma-to-carcinoma sequence. Most of the polypectomies are performed for diminutive (≤5mm) or small (6-10mm) colorectal lesions which represent >90% of the overall burden of resected polyps. Although the potential for neoplasia is usually size-dependent, recent evidence suggested that even diminutive and small polyps harbor a substantial risk of advanced neoplasia (in some series as high as 9-10%). Complete resection of neoplastic polyps is pivotal, as 8.8% to 50% of interval cancers may arise as a consequence of incomplete polypectomy. However, the ideal method to remove small colorectal polyps remains uncertain. Cold snare polypectomy has become standard technique allowing for comprehensive and safe resection of diminutive polyps, though significant incomplete resection rates have challenged the implementation of CSP for larger (in particular 8-10mm) polyps. Submucosal injection of a solution containing a staining dye could improve the outcome of cold snare polypectomy: a) lift of the lesion with submucosal chromoendoscopy could sharply delineate margins and facilitate capture and removal by using a cold snare, and b) formation of a submucosal cushion could minimize mechanical damage to the submucosal vessels, preventing the occurrence of immediate bleeding.

Use of electrocautery is believed to reduce the risk of incomplete resection, although it is less attractive from a safety standpoint due to the risk of complications including delayed bleeding, post-polypectomy syndrome and perforation. Injection of a submucosal solution in order to lift the lesion (injection-assisted endoscopic mucosal resection, EMR) facilitates "hot" resection of sessile or flat neoplasms and allows for a deeper resection margin as compared to conventional polypectomy, while it minimizes electrocautery damage by creating a safety cushion. Despite it is highly efficient, EMR still carries a substantial risk of complications (in most series 7-8%) which has generally limited uptake of the technique among endoscopists for the removal of small polyps.

Therefore, the investigators designed a randomized controlled trial to assess whether injection-assisted cold snare polypectomy may be noninferior to EMR for the resection of small (6-10mm) colorectal polyps.

METHODS

The study will be conducted in the endoscopy units of the Benizelion General Hospital (Heraklion, Crete, Greece) and the Konstantopoulio General Hospital (Nea Ionia, Athens, Greece). Consecutive subjects over the age of 18 years who agree informed consent and who have at least one polyp of eligible size (6-10mm) will be randomly assigned in two groups:

1. Injection-assisted cold snare polypectomy (I-CSP). Polyps in this group will be resected with the cold snare technique after pre-lift of the lesion with a submucosal injection of methylene blue-tinted normal saline solution. The polyp and a small rim of normal tissue will be then snared closely and removed in a single piece without the use of electrocautery.

2. Endoscopic mucosal resection (EMR). Polyps in this group will be removed in a single piece by using an "inject-and-cut" EMR technique. Methylene blue-tinted normal saline solution will be injected into the submucosal space followed by the application of snare cautery for lesion resection.

All polypectomy specimens will be retrieved by suctioning into a polyp trap or by using retrieval forceps and send for histopathological examination.

The polypectomy site will be rinsed with tap water and carefully inspected for residual polyp. Targeted biopsies will be obtained from any areas in the polypectomy site margin suspicious for residual tissue. Protrusions in the polypectomy base after I-CSP will be recorded and a biopsy will be taken for separate histological assessment.

Histological evaluation of polypectomy specimens and post-polypectomy biopsy specimens will rely on the criteria of the World Health Organization and will be performed by experienced GI pathologists blinded to the polytectomy technique used and the endoscopic findings. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02678663
Study type Interventional
Source Benizelion General Hospital
Contact
Status Completed
Phase N/A
Start date January 2016
Completion date January 2017

See also
  Status Clinical Trial Phase
Completed NCT05615857 - Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary N/A
Not yet recruiting NCT02865382 - Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy N/A
Completed NCT02529007 - Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening N/A
Completed NCT02245854 - Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps N/A
Completed NCT01712048 - Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps N/A
Terminated NCT01297712 - Endoscopic Assessment of Polyp Histology N/A
Active, not recruiting NCT01368289 - Australian Multicentre Colonic Endoscopic Mucosal Resection Study
Completed NCT02196649 - Clip Placement Following Endoscopic Mucosal Resection - Randomised Trial N/A
Not yet recruiting NCT00996619 - Measuring the Spectrum of Tissues During Endoscopy N/A
Completed NCT00997802 - Japanese National Computed Tomographic (CT) Colonography Trial N/A
Completed NCT00468455 - Post-Op Quality of Life After Colorectal Surgery N/A
Completed NCT00018551 - Chemoprevention With Folic Acid Phase 2
Recruiting NCT02552017 - Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities N/A
Completed NCT01979458 - Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon N/A
Unknown status NCT01101672 - Trial for Single Port Versus Conventional Laparoscopic Colectomy Phase 2/Phase 3
Terminated NCT01458925 - Feasibility of Check-Cap's P1 Capsule System Screening N/A
Recruiting NCT05737017 - The Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet) N/A
Recruiting NCT02760381 - Acetic Acid for Optical Characterization of Colonic Polyps N/A
Withdrawn NCT04253990 - Efficacy and Safety of Precut-EMR for Resecting of Colonic Polyp N/A
Completed NCT01901510 - Panchromoendoscopy Using Oral Indigo Carmine Mixed With Polyethylene Glycol Prep Phase 1