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Post-resection Treatment of Large Colon Polyps (SAP)

Primary Purpose

Recurrence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Argon Plasma Coagulation
Snare Tip Soft Coagulation
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrence focused on measuring Argon Plasma Coagulation, Snare Tip Soft Coagulation, Recurrence rates

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Sibley Memorial Hospital
  • AdventHealth Orlando
  • Indiana University Health University Hospital
  • Spring Mill Medical Center
  • The University of Kansas Medical Center
  • The Johns Hopkins Hospital
  • Dartmouth-Hitchcock Medical Center
  • NYU Langone Medical Center
  • The Mount Sinai Hospital
  • Penn State Health Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Argon Plasma Coagulation

Snare Tip Soft Coagulation

No treatment

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time
The time it takes to apply each respective treatment (APC or STSC) on the day of procedure
Complications
To look at the number of complications for each randomization arm as assessed through a 30 day follow-up phone call
Cost analysis
Cost analysis detailing the effectiveness of the treatment versus the cost of each therapeutic device (argon probe vs. snare)

Full Information

First Posted
August 23, 2018
Last Updated
May 4, 2023
Sponsor
Indiana University
Collaborators
Erbe USA Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT03654209
Brief Title
Post-resection Treatment of Large Colon Polyps
Acronym
SAP
Official Title
Prospective Randomized Controlled Trial Describing the Recurrence Rate of Adenomas in Sessile or Flat Colonic Lesions 15mm or Larger Receiving Post-resection Site Treatment With Snare Tip Soft Coagulation or Argon Plasma Coagulation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Erbe USA Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Data regarding polyp morphology, location & shape will be recorded in addition to procedure and treatment length. Injection fluid use and clipping will also be recorded in addition to any procedural complications. All randomized subjects will receive a 30-day post procedure follow-up phone call and be scheduled, as per the standard of care, to receive a standard follow-up colonoscopy procedure after the initial procedure. The investigators will measure the rate of recurrence by endoscopic visualization of the EMR site at the first follow-up using endoscopic magnification and electronic chromoendoscopy, as well as systematic biopsy of the scars.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrence
Keywords
Argon Plasma Coagulation, Snare Tip Soft Coagulation, Recurrence rates

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to Argon Plasma Coagulation vs Snare Tip Soft Coagulation vs no treatment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Argon Plasma Coagulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Snare Tip Soft Coagulation
Arm Type
Experimental
Arm Description
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.
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Argon Plasma Coagulation
Intervention Description
APC will be applied to the perimeter of the resection site
Intervention Type
Device
Intervention Name(s)
Snare Tip Soft Coagulation
Intervention Description
STSC will be applied to the perimeter of the resection site
Primary Outcome Measure Information:
Title
Recurrence
Description
The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Time
Description
The time it takes to apply each respective treatment (APC or STSC) on the day of procedure
Time Frame
1 day
Title
Complications
Description
To look at the number of complications for each randomization arm as assessed through a 30 day follow-up phone call
Time Frame
1 day
Title
Cost analysis
Description
Cost analysis detailing the effectiveness of the treatment versus the cost of each therapeutic device (argon probe vs. snare)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 25 years and older Ability to provide informed consent Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion Exclusion Criteria: Pedunculated lesions Inflammatory bowel disease Inability to provide informed consent Lesions less than 15mm in largest dimension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas K. Rex, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Indiana University Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Spring Mill Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data can be shared in the future upon request.
Citations:
PubMed Identifier
27271329
Citation
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.
Results Reference
background
PubMed Identifier
11868011
Citation
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.
Results Reference
background
PubMed Identifier
29020690
Citation
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.
Results Reference
background

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Post-resection Treatment of Large Colon Polyps

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