NCT03654209

Brief Summary

Patients who have provided informed consented and are scheduled to undergo endoscopic mucosal resection (EMR) of lesions 15mm and larger will be randomized to STSC (80 W, Effect 5) vs APC (preferred settings) vs No Treatment of the perimeter of the EMR site.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

10 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

First Submitted

Initial submission to the registry

August 23, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 16, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2024

Enrollment Period

4.2 years

First QC Date

August 23, 2018

Results QC Date

December 8, 2023

Last Update Submit

January 2, 2024

Conditions

Recurrence

Keywords

Argon Plasma CoagulationSnare Tip Soft CoagulationRecurrence rates

Outcome Measures

Primary Outcomes (2)

  • Recurrence

    The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy

    1 day

  • Types of Recurrences

    Description of whether recurrence was visible during the follow-up procedure and confirmed by pathology, visible during the follow-up procedure but not confirmed by pathology, or not visible during the follow-up procedure but confirmed by pathology of biopsies taken.

    1 day

Secondary Outcomes (2)

  • Time

    1 day

  • Complications

    1 day

Study Arms (3)

Argon Plasma Coagulation

EXPERIMENTAL

Following polyp removal using standard of care methods, Argon Plasma Coagulation (APC) will be applied to the perimeter of the resection site before any clips are added.

Device: Argon Plasma Coagulation

Snare Tip Soft Coagulation

EXPERIMENTAL

Following polyp removal using standard of care methods, Snare Tip Soft Coagulation (STSC) will be applied to the perimeter of the resection site before any clips are added.

Device: Snare Tip Soft Coagulation

No treatment

NO INTERVENTION

Following polyp removal using standard of care methods, neither APC nor STSC will be applied to the perimeter of the resection site. Clips may be added at the discretion of the PI.

Interventions

Argon Plasma CoagulationDEVICE

APC will be applied to the perimeter of the resection site

Argon Plasma Coagulation
Snare Tip Soft CoagulationDEVICE

STSC will be applied to the perimeter of the resection site

Snare Tip Soft Coagulation

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Ability to provide informed consent
  • Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion

You may not qualify if:

  • Pedunculated lesions
  • Inflammatory bowel disease
  • Inability to provide informed consent
  • Lesions less than 15mm in largest dimension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Spring Mill Medical Center

Indianapolis, Indiana, 46290, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (4)

  • Zhan T, Hielscher T, Hahn F, Hauf C, Betge J, Ebert MP, Belle S. Risk Factors for Local Recurrence of Large, Flat Colorectal Polyps after Endoscopic Mucosal Resection. Digestion. 2016;93(4):311-7. doi: 10.1159/000446364. Epub 2016 Jun 7.

    PMID: 27271329BACKGROUND

  • Brooker JC, Saunders BP, Shah SG, Thapar CJ, Suzuki N, Williams CB. Treatment with argon plasma coagulation reduces recurrence after piecemeal resection of large sessile colonic polyps: a randomized trial and recommendations. Gastrointest Endosc. 2002 Mar;55(3):371-5. doi: 10.1067/mge.2002.121597.

    PMID: 11868011BACKGROUND

  • Tate DJ, Bahin FF, Desomer L, Sidhu M, Gupta V, Bourke MJ. Cold-forceps avulsion with adjuvant snare-tip soft coagulation (CAST) is an effective and safe strategy for the management of non-lifting large laterally spreading colonic lesions. Endoscopy. 2018 Jan;50(1):52-62. doi: 10.1055/s-0043-119215. Epub 2017 Oct 11.

    PMID: 29020690BACKGROUND

  • Rex DK, Haber GB, Khashab M, Rastogi A, Hasan MK, DiMaio CJ, Kumta NA, Nagula S, Gordon S, Al-Kawas F, Waye JD, Razjouyan H, Dye CE, Moyer MT, Shultz J, Lahr RE, Yuen PYS, Dixon R, Boyd L, Pohl H. Snare Tip Soft Coagulation vs Argon Plasma Coagulation vs No Margin Treatment After Large Nonpedunculated Colorectal Polyp Resection: a Randomized Trial. Clin Gastroenterol Hepatol. 2024 Mar;22(3):552-561.e4. doi: 10.1016/j.cgh.2023.09.041. Epub 2023 Oct 21.

    PMID: 37871841DERIVED

MeSH Terms

Conditions

Recurrence

Interventions

Argon Plasma Coagulation

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ElectrocoagulationCauteryTherapeuticsHemostatic TechniquesAblation TechniquesSurgical Procedures, OperativeHemostasis, Surgical

Limitations and Caveats

Imbalance in patient recruitment among sites. We included polyps resected en bloc \& 15-19mm polyps. Whether margin treatment is beneficial after en bloc resection or removal of 15-19 mm polyps is unknown. Endoscopists couldn't be blinded to randomized treatment. Dropout rate was higher than expected, so planned power was slightly reduced.

Results Point of Contact

Title
Clinical Research Coordinator
Organization
Indiana University
rlahr@iu.edu
317-948-0724

Study Officials

  • Douglas K. Rex, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be randomized to Argon Plasma Coagulation vs Snare Tip Soft Coagulation vs no treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 31, 2018

Study Start

October 16, 2018

Primary Completion

December 14, 2022

Study Completion

December 14, 2022

Last Updated

January 5, 2024

Results First Posted

January 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

De-identified data can be shared in the future upon request.

Locations

US(10)