Colon PolypsNCT01936948
Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.
A study testing Clip closure in people with Colon Polyps, run by White River Junction Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Colon Polyps
- What is being tested?
- Clip closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 928 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Oct 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient ≥18 and ≤89 who presents for a colonoscopy and who does not have criteria for exclusion
- Patients with a ≥20mm non-pedunculated colon polyp
Who cannot join
- Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
- Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
- Patients with inflammatory bowel disease
- Patients who are receiving an emergency colonoscopy
- Poor general health (ASA class>3)
Show all 9Show fewer
- Patients with coagulopathy with an elevated INR ≥1.5, or platelets <50
- Poor bowel preparation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
White River Junction VAMC
White River Junction, Vermont, 05009
About this study
The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) using electrocautery snares. Resection of these large polyps is associated with a risk of severe complications that may require hospitalization and additional interventions. The most common risk is delayed bleeding which is observed in approximately 2-9% of patients. A recent retrospective study suggests that closure of the large mucosal defect after resection may decrease the risk of delayed bleeding. However, significant uncertainty remains about the polypectomy techniques to optimizing resection and minimizing risk. Important aspects that may affect risk include clipping of the mucosal defect and electrocautery setting.
Read the detailed description
Aim 1. The primary aim of the study is to compare the rate of delayed bleeding complications in patients undergoing endoscopic resection of large polyps between:
- A) Closing the mucosal defect after resection (Clip group) and
- B) Not closing the mucosal defect after resection (No clip group).
Aim 2. The secondary aim of the study is to compare the rate of overall complications in patients undergoing endoscopic resection of large polyps between two cautery settings:
- A) Low power coagulation and
- B) Endocut.
- Conditions
- Colon Polyps
- Being tested
- Clip closure
- Keywords
- Large colon polyps, Polyp resection, Colon cancer screening, Colonoscopy, Endoscopic mucosal resection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clip closureProcedure or surgery
Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.
| Study group | Role | What they receive |
|---|---|---|
| Clip closure + EndoCut | Active comparator | Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode. Receives: Procedure: Clip closure |
| Clip closure + Coagulation | Active comparator | Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode. Receives: Procedure: Clip closure |
| No clip closure + EndoCut | No intervention | No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode. |
| No clip closure + Coagulation | No intervention | No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Delayed Bleeding Complications
A bleeding event that occurred within 30 days after completion of the colonoscopy with a study polyp resection and is associated with a decrease in hemoglobin by at least 2gm, hemodynamic instability, presentation to the ED, need for hospitalization, repeat colonoscopy, or other interventions.
Measured: 30 days following a study polyp resection
Secondary outcomes (4)
The Overall Number of Complications
Overall complications are defined as an aggregate of all complications that occur at the time of the procedure (immediate complications) or during 30 days of follow-up. They include delayed bleeding complications, perforation, postpolypectomy syndrome, and clinical events that require an ED visit, admission to the hospital, additional testing or an intervention.
Measured: 30 days
Complete Study Polyp Resection Rate
Rate of complete study polyp resection at the initial colonoscopy and at first follow-up endoscopy
Measured: 6 months
Polyp Recurrence Rate
Rate of recurrent polyp at the resection site after complete polyp resection.
Measured: 3 months to 5 years
The Number of Complications Associated With Clip Use
Incidence of complications associated with application of clips.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startApr 2013
- Primary completion30 Jun 2018
- Study completionOct 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 (3)Papers the sponsor has linked to this study.
- Other trials for Colon PolypsStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 928 participants (actual)
Sponsor and investigators
- Lead sponsor
- White River Junction Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Dartmouth College, Boston Scientific Corporation
- Responsible party
- Principal investigator, Dr. Heiko Pohl, White River Junction Veterans Affairs Medical Center
- Investigators
- Heiko Pohl, Study chair, White River Junction VAMC, Geisel School of Medicine at Dartmouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936948
- Sponsor's protocol ID
- CPHS-23578
- Status last verified
- Jun 2024
- First submitted
- 3 Sep 2013
- Last updated
- 12 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Crockett SD, Khashab M, Rex DK, Grimm IS, Moyer MT, Rastogi A, Mackenzie TA, Pohl H; Large Polyp Study Group Consortium. Clip Closure Does Not Reduce Risk of Bleeding After Resection of Large Serrated Polyps: Results From a Randomized Trial. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1757-1765.e4. doi: 10.1016/j.cgh.2021.12.036. Epub 2021 Dec 28.
PubMed 34971811Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Mackenzie TA, Rex DK. Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial. Gastroenterology. 2020 Jul;159(1):119-128.e2. doi: 10.1053/j.gastro.2020.03.014. Epub 2020 Mar 12.
PubMed 32173478Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Wallace MB, Mackenzie TA, Rex DK. Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019. Epub 2019 Mar 15.
PubMed 30885778
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.
- ClinicalTrials.gov ID
- NCT01936948
- Acronym / sponsor ID
- CPHS-23578
- Conditions
- Colon Polyps
- Keywords
- Large colon polyps, Polyp resection, Colon cancer screening, Colonoscopy, Endoscopic mucosal resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 928 participants (actual)
- Lead sponsor
- White River Junction Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Dartmouth College, Boston Scientific Corporation
- Study start
- Apr 2013 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Posted 22 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) using electrocautery snares. Resection of these large polyps is associated with a risk of severe complications that may require hospitalization and additional interventions. The most common risk is delayed bleeding which is observed in approximately 2-9% of patients. A recent retrospective study suggests that closure of the large mucosal defect after resection may decrease the risk of delayed bleeding. However, significant uncertainty remains about the polypectomy techniques to optimizing resection and minimizing risk. Important aspects that may affect risk include clipping of the mucosal defect and electrocautery setting.
Detailed description
Aim 1. The primary aim of the study is to compare the rate of delayed bleeding complications in patients undergoing endoscopic resection of large polyps between:
- A) Closing the mucosal defect after resection (Clip group) and
- B) Not closing the mucosal defect after resection (No clip group).
Aim 2. The secondary aim of the study is to compare the rate of overall complications in patients undergoing endoscopic resection of large polyps between two cautery settings:
- A) Low power coagulation and
- B) Endocut.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clip closure + EndoCut | Active comparator | Procedure: Clip closureClipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the EndoCut electrocautery mode. |
| Clip closure + Coagulation | Active comparator | Procedure: Clip closureClipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode. |
| No clip closure + EndoCut | No intervention | –No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode. |
| No clip closure + Coagulation | No intervention | –No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient ≥18 and ≤89 who presents for a colonoscopy and who does not have criteria for exclusion
- Patients with a ≥20mm non-pedunculated colon polyp
Key exclusion criteria (9 listed)
- Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
- Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
- Patients with inflammatory bowel disease
- Patients who are receiving an emergency colonoscopy
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 |
|---|---|---|
| Clip closurePatients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis. | Procedure or surgery | Clip closure + Coagulation, Clip closure + EndoCut |
Primary outcome
Number of Participants With Delayed Bleeding Complications
Time frame: 30 days following a study polyp resection
A bleeding event that occurred within 30 days after completion of the colonoscopy with a study polyp resection and is associated with a decrease in hemoglobin by at least 2gm, hemodynamic instability, presentation to the ED, need for hospitalization, repeat colonoscopy, or other interventions.
4 secondary outcomes
The Overall Number of Complications
Time frame: 30 days
Complete Study Polyp Resection Rate
Time frame: 6 months
Polyp Recurrence Rate
Time frame: 3 months to 5 years
The Number of Complications Associated With Clip Use
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34971811Crockett SD, Khashab M, Rex DK, Grimm IS, Moyer MT, Rastogi A, Mackenzie TA, Pohl H; Large Polyp Study Group Consortium. Clip Closure Does Not Reduce Risk of Bleeding After Resection of Large Serrated Polyps: Results From a Randomized Trial. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1757-1765.e4. doi: 10.1016/j.cgh.2021.12.036. Epub 2021 Dec 28.
- Derived from this study: PubMed 32173478Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Mackenzie TA, Rex DK. Effects of Blended (Yellow) vs Forced Coagulation (Blue) Currents on Adverse Events, Complete Resection, or Polyp Recurrence After Polypectomy in a Large Randomized Trial. Gastroenterology. 2020 Jul;159(1):119-128.e2. doi: 10.1053/j.gastro.2020.03.014. Epub 2020 Mar 12.
- Derived from this study: PubMed 30885778Pohl H, Grimm IS, Moyer MT, Hasan MK, Pleskow D, Elmunzer BJ, Khashab MA, Sanaei O, Al-Kawas FH, Gordon SR, Mathew A, Levenick JM, Aslanian HR, Antaki F, von Renteln D, Crockett SD, Rastogi A, Gill JA, Law RJ, Elias PA, Pellise M, Wallace MB, Mackenzie TA, Rex DK. Clip Closure Prevents Bleeding After Endoscopic Resection of Large Colon Polyps in a Randomized Trial. Gastroenterology. 2019 Oct;157(4):977-984.e3. doi: 10.1053/j.gastro.2019.03.019. Epub 2019 Mar 15.
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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.
Heiko Pohl study chair
White River Junction VAMC, Geisel School of Medicine at Dartmouth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clip closure in people with Colon Polyps, run by White River Junction Veterans Affairs Medical Center at 1 site 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 2 inclusion and 9 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 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 22 Jun 2021). 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?
Number of Participants With Delayed Bleeding Complications (time frame: 30 days following a study polyp resection). 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 NCT01936948, which also lists 3 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 12 Jul 2024.