NCT02678663

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

February 3, 2016

Last Update Submit

January 30, 2017

Conditions

Colonic Polyps

Keywords

Colon polypPolypectomyCold snareEndoscopic mucosal resection

Outcome Measures

Primary Outcomes (1)

  • Complete Resection Rate

    Two weeks after each polypectomy

Secondary Outcomes (3)

  • Incidence of complications (intraprocedural bleeding, postprocedural bleeding, post-polypectomy syndrome, perforation).

    Two weeks after each polypectomy

  • Necessity of hemostasis (due to intraprocedural or postprocedural bleeding)

    Two weeks after each polypectomy

  • Polyp retrieval rate

    Two weeks after each polypectomy

Study Arms (2)

Injection-assisted cold snare polypectomy (I-CSP)

EXPERIMENTAL

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.

Procedure: Injection-assisted Cold Snare Polypectomy

Endoscopic mucosal resection (EMR).

ACTIVE COMPARATOR

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.

Procedure: Endoscopic Mucosal Resection

Interventions

Injection-assisted Cold Snare PolypectomyPROCEDURE

Resection of a polyp after blue-tinted saline injection using a cold snare (without application of electrocautery)

Injection-assisted cold snare polypectomy (I-CSP)
Endoscopic Mucosal ResectionPROCEDURE

Resection of a polyp after blue-tinted saline injection using snare electrocautery

Endoscopic mucosal resection (EMR).

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects over the age of 18 years who agree informed consent and who have at least one polyp of eligible size (6-10mm)

You may not qualify if:

  • Anticoagulant therapy during the past 1 week of the procedure
  • Known coagulopathy
  • History of liver cirrhosis, chronic kidney disease, malignancy, inflammatory bowel disease, significant infectious disease, polyposis syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Konstantopoulio General Hospital

Nea Ionia, Athens, 14233, Greece

Location

Benizelion General Hospital

Heraklion, Crete, 71409, Greece

Location

Related Publications (1)

  • Papastergiou V, Paraskeva KD, Fragaki M, Dimas I, Vardas E, Theodoropoulou A, Mathou N, Giannakopoulos A, Karmiris K, Mpitouli A, Apessou D, Giannikaki L, Karagiannis JA, Chlouverakis G, Paspatis GA. Cold versus hot endoscopic mucosal resection for nonpedunculated colorectal polyps sized 6-10 mm: a randomized trial. Endoscopy. 2018 Apr;50(4):403-411. doi: 10.1055/s-0043-118594. Epub 2017 Sep 12.

    PMID: 28898922DERIVED

MeSH Terms

Conditions

Colonic Polyps

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 10, 2016

Study Start

January 1, 2016

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

January 31, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

GR(2)