RecurrenceSAPNCT03654209
Post-resection Treatment of Large Colon Polyps
A study testing Argon Plasma Coagulation and Snare Tip Soft Coagulation in people with Recurrence, run by Indiana University at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recurrence
- What is being tested?
- Argon Plasma Coagulation and Snare Tip Soft Coagulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 10 sitesUnited States
- Study dates
- 16 Oct 2018to 14 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 25 years and older
- Ability to provide informed consent
- Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion
Who cannot join
- Pedunculated lesions
- Inflammatory bowel disease
- Inability to provide informed consent
- Lesions less than 15mm in largest dimension
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Spring Mill Medical Center
Indianapolis, Indiana, 46290
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
NYU Langone Medical Center
New York, New York, 10016
The Mount Sinai Hospital
New York, New York, 10029
AdventHealth Orlando
Orlando, Florida, 32803
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
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
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.
Read the 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.
- Conditions
- Recurrence
- Being tested
- Argon Plasma Coagulation, Snare Tip Soft Coagulation
- Keywords
- Argon Plasma Coagulation, Snare Tip Soft Coagulation, Recurrence rates
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon Plasma CoagulationDevice
APC will be applied to the perimeter of the resection site
Snare Tip Soft CoagulationDevice
STSC will be applied to the perimeter of the resection site
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy
Measured: 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.
Measured: 1 day
Secondary outcomes (2)
Time
The time it takes to apply each respective treatment (APC or STSC) on the day of procedure
Measured: 1 day
Complications
To look at the number of complications for each randomization arm as assessed through a 30 day follow-up period
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start16 Oct 2018
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for RecurrenceStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to Argon Plasma Coagulation vs Snare Tip Soft Coagulation vs no treatment
- Masking
- None (open label)
- Enrolment
- 384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Erbe USA Incorporated
- Responsible party
- Principal investigator, Douglas K. Rex, Indiana University
- Investigators
- Douglas K. Rex, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654209
- Sponsor's protocol ID
- 1805411306
- Acronym
- SAP
- Status last verified
- Jan 2024
- First submitted
- 23 Aug 2018
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: De-identified data can be shared in the future upon request.
Publications
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.
PubMed 27271329Brooker 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.
PubMed 11868011Tate 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.
PubMed 29020690Rex 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.
PubMed 37871841
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03654209
- Acronym / sponsor ID
- SAP / 1805411306
- Conditions
- Recurrence
- Keywords
- Argon Plasma Coagulation, Snare Tip Soft Coagulation, Recurrence rates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 384 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Erbe USA Incorporated
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be randomized to Argon Plasma Coagulation vs Snare Tip Soft Coagulation vs no treatment
| Arm | Type | Receives |
|---|---|---|
| Argon Plasma Coagulation | Experimental | Device: Argon Plasma CoagulationFollowing 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. |
| Snare Tip Soft Coagulation | Experimental | Device: Snare Tip Soft CoagulationFollowing 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. |
| 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 25 years and older
- Ability to provide informed consent
- Undergoing colonoscopy for screening, surveillance, diagnostic reasons, or removal of a lesion
Key exclusion criteria (4 listed)
- Pedunculated lesions
- Inflammatory bowel disease
- Inability to provide informed consent
- Lesions less than 15mm in largest dimension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Argon Plasma CoagulationAPC will be applied to the perimeter of the resection site | Device | Argon Plasma Coagulation |
| Snare Tip Soft CoagulationSTSC will be applied to the perimeter of the resection site | Device | Snare Tip Soft Coagulation |
Primary outcome
Recurrence
Time frame: 1 day
The recurrence rate of adenomas at the site of any qualifying, previously resected lesions will be measured at the first follow-up colonoscopy
Types of Recurrences
Time frame: 1 day
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.
2 secondary outcomes
Time
Time frame: 1 day
Complications
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27271329Zhan 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.
- Background: PubMed 11868011Brooker 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.
- Background: PubMed 29020690Tate 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.
- Derived from this study: PubMed 37871841Rex 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.
- Individual participant dataSharing planned: No. De-identified data can be shared in the future upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas K. Rex, MD principal investigator
Indiana University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Argon Plasma Coagulation and Snare Tip Soft Coagulation in people with Recurrence, run by Indiana University at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03654209, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.