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CompletedNCT01936948Updated Jul 12, 2024Results posted

Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

An interventional study of Clip closure in Colon Polyps, sponsored by White River Junction Veterans Affairs Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by White River Junction Veterans Affairs Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
928
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Colon Polyps

Keywords

  • Large colon polyps
  • Polyp resection
  • Colon cancer screening
  • Colonoscopy
  • Endoscopic mucosal resection
03

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • Patients with coagulopathy with an elevated INR ≥1.5, or platelets \<50
  • Poor bowel preparation
  • Pregnancy
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
928 participants (actual)

Study arms

  • Active comparator
    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.

    Procedure: Clip closure

  • Active comparator
    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.

    Procedure: Clip closure

  • No intervention
    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.

  • No intervention
    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.

Interventions

  • ProcedureClip 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days following a study polyp resection

Secondary outcomes

  1. 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.

    Time frame: 30 days

  2. Complete Study Polyp Resection Rate

    Rate of complete study polyp resection at the initial colonoscopy and at first follow-up endoscopy

    Time frame: 6 months

  3. Polyp Recurrence Rate

    Rate of recurrent polyp at the resection site after complete polyp resection.

    Time frame: 3 months to 5 years

  4. The Number of Complications Associated With Clip Use

    Incidence of complications associated with application of clips.

    Time frame: 30 days

Other outcomes

  1. 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.

    Time frame: 30 days

  2. 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.

    Time frame: 5 years

06

Results

Posted Jun 22, 2021
Limitations and caveats
Complete defect closure not possible in 13% of patients. Crossover to clip group in 10% of patients.

Participant flow

Participant flow — Overall Study
MilestoneClip Closure + EndoCutClip Closure + CoagulationNo Clip Closure + EndoCutNo Clip Closure + Coagulation
Started227231237233
Crossover31272225
Completed227228234230
Not completed0333
Withdrew: No 30-day follow-up data0333

Outcome measures

PrimaryNumber 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.

Time frame:
30 days following a study polyp resection
Reported as:
Count of participants · Participants
Number of Participants With Delayed Bleeding Complications
ParticipantsClip ClosureNo Clip Closure
Number of Participants With Delayed Bleeding Complications1633
SecondaryThe 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.

Time frame:
30 days
Reported as:
Count of participants · Participants
The Overall Number of Complications
ParticipantsClip ClosureNo Clip Closure
The Overall Number of Complications2244
SecondaryComplete Study Polyp Resection Rate

Rate of complete study polyp resection at the initial colonoscopy and at first follow-up endoscopy

Time frame:
6 months

Results for this outcome have not been posted.

SecondaryPolyp Recurrence Rate

Rate of recurrent polyp at the resection site after complete polyp resection.

Time frame:
3 months to 5 years

Results for this outcome have not been posted.

SecondaryThe Number of Complications Associated With Clip Use

Incidence of complications associated with application of clips.

Time frame:
30 days

Results for this outcome have not been posted.

Other pre-specifiedMeasured 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.

Time frame:
30 days

Results for this outcome have not been posted.

Other pre-specifiedMeasured 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.

Time frame:
5 years

Results for this outcome have not been posted.

Adverse events

Collected over Within 30 days of the colonoscopy.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Clip Closure + EndoCut0/227 (0%)11/227 (4.8%)34/227 (15%)
Clip Closure + Coagulation0/228 (0%)11/228 (4.8%)20/228 (8.8%)
No Clip Closure + EndoCut2/234 (0.9%)21/234 (9%)33/234 (14.1%)
No Clip Closure + Coagulation0/230 (0%)23/230 (10%)21/230 (9.1%)
Most frequent serious events
Most frequent serious events
EventClip Closure + EndoCutClip Closure + CoagulationNo Clip Closure + EndoCutNo Clip Closure + Coagulation
Postprocedure hemorrhageSurgical and medical procedures6/22710/22816/23417/230
PerforationSurgical and medical procedures3/2270/2283/2343/230
Intraprocedural bleedingSurgical and medical procedures1/2270/2280/2340/230
Postpolypectomy syndromeGastrointestinal disorders1/2270/2280/2341/230
Abdominal PainSurgical and medical procedures0/2271/2281/2341/230
OtherGeneral disorders0/2270/2281/2341/230
Most frequent other events
Most frequent other events
EventClip Closure + EndoCutClip Closure + CoagulationNo Clip Closure + EndoCutNo Clip Closure + Coagulation
BleedingGastrointestinal disorders15/2275/22816/23416/230
Abdominal PainGastrointestinal disorders11/22710/22811/2347/230
OtherGeneral disorders6/2275/2283/2342/230
Headaches/FeversGeneral disorders1/2274/2283/2341/230
Bowel movement problemsGastrointestinal disorders3/2271/2281/2342/230
Blood pressure problemsGeneral disorders2/2270/2280/2340/230
Urinary issuesRenal and urinary disorders1/2270/2282/2341/230
Cardiovascular eventCardiac disorders0/2271/2280/2340/230
Post-polypectomy syndromeGastrointestinal disorders0/2271/2281/2340/230

Baseline characteristics

Age, Continuous
Age, Continuous(years)Clip Closure + EndoCutClip Closure + CoagulationNo Clip Closure + EndoCutNo Clip Closure + CoagulationTotal
Mean64.7 ± 9.765.5 ± 9.264.8 ± 9.865.3 ± 9.865.1 ± 9.6
Sex: Female, Male
Sex: Female, Male(Participants)Clip Closure + EndoCutClip Closure + CoagulationNo Clip Closure + EndoCutNo Clip Closure + CoagulationTotal
Female92989690376
Male135133141143552
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Clip Closure + EndoCutClip Closure + CoagulationNo Clip Closure + EndoCutNo Clip Closure + CoagulationTotal
American Indian or Alaska Native00000
Asian22127
Native Hawaiian or Other Pacific Islander00000
Black or African American1618111762
White200202214205821
More than one race00000
Unknown or Not Reported9911938
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Clip Closure + EndoCutClip Closure + CoagulationNo Clip Closure + EndoCutNo Clip Closure + CoagulationTotal
Mean29.5 ± 6.629.0 ± 5.629.1 ± 6.229.1 ± 5.629.2 ± 6.0
ASA Class
ASA Class(Participants)Clip Closure + EndoCutClip Closure + CoagulationNo Clip Closure + EndoCutNo Clip Closure + CoagulationTotal
ASA I - normal healthy patient2317192079
ASA II - patient with mild systemic disease125133134121513
ASA III - patient with severe systemic disease79818492336
Periprocedural Antithrombic Medications
Periprocedural Antithrombic Medications(Participants)Clip Closure + EndoCutClip Closure + CoagulationNo Clip Closure + EndoCutNo Clip Closure + CoagulationTotal
Antiplatelet agents54476170232
Anticoagulants515131649
None168169163147647
Procedure Sedation
Procedure Sedation(Participants)Clip Closure + EndoCutClip Closure + CoagulationNo Clip Closure + EndoCutNo Clip Closure + CoagulationTotal
No Sedation14016
Moderate Sedation32263325116
Monitored Anesthesia194201204207806
Quality of Bowel Preparation
Quality of Bowel Preparation(Participants)Clip Closure + EndoCutClip Closure + CoagulationNo Clip Closure + EndoCutNo Clip Closure + CoagulationTotal
Excellent62645568249
Good123133146127529
Fair42343638150

3 further baseline measures are reported on the registry.

07

Study locations

1 site
  • White River Junction VAMC
    White River Junction, Vermont 05009, United States
08

References and documents

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 34971811 ↗
  • 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. PubMed 32173478 ↗
  • 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. PubMed 30885778 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 13, 2019

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT01936948
Lead sponsor
White River Junction Veterans Affairs Medical Center
Collaborators
Dartmouth College, Boston Scientific Corporation
Responsible party
Dr. Heiko Pohl (Principal Investigator, White River Junction Veterans Affairs Medical Center) — Principal investigator
First posted
Sep 6, 2013
Start date
Apr 2013
Primary completion
Jun 30, 2018
Completion
Oct 2022
Results posted
Jun 22, 2021
Last update
Jul 12, 2024

Study contacts

Heiko Pohl
study chair · White River Junction VAMC, Geisel School of Medicine at Dartmouth

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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