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| Name | Class |
|---|---|
| Dartmouth College | OTHER |
| Boston Scientific Corporation | INDUSTRY |
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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.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clip closure | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days following a study polyp resection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Measured Factors Associated With Resection Complications | Factors that may be associated with complications, including electrocautery setting, polyp size, location of the polyp in the colon (right, left, rectum), histology, polyp morphology, time required for resection. | 30 days |
| Measured Factors Associated With Incomplete Resection or Recurrence of Polyps |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heiko Pohl | White River Junction VAMC, Geisel School of Medicine at Dartmouth | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| White River Junction VAMC | White River Junction | Vermont | 05009 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34971811 | Derived | 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. | |
| 32173478 |
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Some of the inclusion/exclusion criteria, e.g. polyp size, poor bowel preparation, could not be assessed until after the start of the colonoscopy. Therefore, informed consent was obtained and the patient enrolled in the study prior to the procedure. Only when it was determined that the patient was eligible for the study were they then randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Clip Closure + EndoCut | Clipping 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: 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. |
| FG001 | Clip Closure + Coagulation | Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode. Clip closure: 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. |
| FG002 | No Clip Closure + EndoCut | No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode. |
| FG003 | No Clip Closure + Coagulation | No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clip Closure + EndoCut | Clipping 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: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | As per study protocol, the primary analysis was done using clip/no clip closure as the study groups. Data for 9 patients was not available. | Posted | Count of Participants | Participants | 30 days following a study polyp resection |
|
Within 30 days of the colonoscopy.
Patients who crossed over (i.e. in the control group, but underwent clip closure) are analyzed as intention to treat, and are therefore analyzed in the control group. Therefore the number of patients at risk equals the number of patients in each group with available follow-up data. For non-SAEs, the number affected does not equal to the number of events because some patients reported multiple adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clip Closure + EndoCut | Clipping 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: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postprocedure hemorrhage | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment | Does not include abdominal pain caused by perforation nor post-polypectomy syndrome. |
Complete defect closure not possible in 13% of patients. Crossover to clip group in 10% of patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heiko Pohl | White River Junction VA Medical Center | 802-295-9363 | 5591 | heiko.pohl@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2019 | Oct 8, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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|
| 30 days |
| Complete Study Polyp Resection Rate | Rate of complete study polyp resection at the initial colonoscopy and at first follow-up endoscopy | 6 months |
| Polyp Recurrence Rate | Rate of recurrent polyp at the resection site after complete polyp resection. | 3 months to 5 years |
| The Number of Complications Associated With Clip Use | Incidence of complications associated with application of clips. | 30 days |
Factors that may be associated with incomplete resection may include prior attempts of removal, use of adjunctive argon plasma coagulation for residual polyp removal, polyp size, location, histology. |
| 5 years |
| Pohl 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. |
| 30885778 | Derived | Pohl 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. |
| BG001 | Clip Closure + Coagulation | Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode. Clip closure: 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. |
| BG002 | No Clip Closure + EndoCut | No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode. |
| BG003 | No Clip Closure + Coagulation | No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| ASA Class | The American Society of Anesthesiologist (ASA) Classification is a grading system to assess a patient's fitness before undergoing a surgical procedure. | Count of Participants | Participants |
|
| Periprocedural Antithrombic Medications | Count of Participants | Participants |
|
| Procedure Sedation | Count of Participants | Participants |
|
| Quality of Bowel Preparation | Count of Participants | Participants |
|
| Electrocautery | Count of Participants | Participants |
|
| Additional Polyps (any size) | Count of Participants | Participants |
|
| More Than One Study Polyp | Count of Participants | Participants |
|
| OG001 | No Clip Closure | No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode or the Coagulation electrocautery mode. |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Complete Study Polyp Resection Rate | Rate of complete study polyp resection at the initial colonoscopy and at first follow-up endoscopy | Not Posted | 6 months | Participants |
| Secondary | Polyp Recurrence Rate | Rate of recurrent polyp at the resection site after complete polyp resection. | Not Posted | 3 months to 5 years | Participants |
| Secondary | The Number of Complications Associated With Clip Use | Incidence of complications associated with application of clips. | Not Posted | 30 days | Participants |
| Other Pre-specified | Measured Factors Associated With Resection Complications | Factors that may be associated with complications, including electrocautery setting, polyp size, location of the polyp in the colon (right, left, rectum), histology, polyp morphology, time required for resection. | Not Posted | 30 days | Participants |
| Other Pre-specified | Measured Factors Associated With Incomplete Resection or Recurrence of Polyps | Factors that may be associated with incomplete resection may include prior attempts of removal, use of adjunctive argon plasma coagulation for residual polyp removal, polyp size, location, histology. | Not Posted | 5 years | Participants |
| 0 |
| 227 |
| 11 |
| 227 |
| 34 |
| 227 |
| EG001 | Clip Closure + Coagulation | Clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp using clips. Resection is done using the Coagulation electrocautery mode. Clip closure: 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. | 0 | 228 | 11 | 228 | 20 | 228 |
| EG002 | No Clip Closure + EndoCut | No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the EndoCut electrocautery mode. | 2 | 234 | 21 | 234 | 33 | 234 |
| EG003 | No Clip Closure + Coagulation | No clipping of the mucosal defect after resection of a ≥20mm non-pedunculated study polyp. Resection is done using the Coagulation electrocautery mode. | 0 | 230 | 23 | 230 | 21 | 230 |
| Intraprocedural bleeding | Surgical and medical procedures | Systematic Assessment |
|
| Abdominal Pain | Surgical and medical procedures | Systematic Assessment |
|
| Perforation | Surgical and medical procedures | Systematic Assessment |
|
| Postpolypectomy syndrome | Gastrointestinal disorders | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
|
| Bleeding | Gastrointestinal disorders | Systematic Assessment | Post procedure bleeding. |
|
| Blood pressure problems | General disorders | Systematic Assessment | Reports of either hypo or hypertension following the procedure. |
|
| Bowel movement problems | Gastrointestinal disorders | Systematic Assessment | Either constipation or diarrhea following the colonoscopy. |
|
| Urinary issues | Renal and urinary disorders | Systematic Assessment | Reports of urinary tract infection following the procedure. |
|
| Cardiovascular event | Cardiac disorders | Systematic Assessment |
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| Headaches/Fevers | General disorders | Systematic Assessment |
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| Other | General disorders | Systematic Assessment | Used when only a few cases were reported. This category includes fatigue, rash, vomiting, feeling sore, eye pain, possible allergic reaction or cramps. |
|
| Post-polypectomy syndrome | Gastrointestinal disorders | Systematic Assessment |
|
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