Wound Endoscopical, ColonEndoClot™NCT05029934
Efficacy of EndoClot™ Spraying After Endoscopic Resection of Large Colorectal Polyps
A study testing use of EndoClot in people with Wound Endoscopical, Colon and After Polyp Resection, Colon, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in Germany.
Trial summary
The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Effective and safe resection of larger polyps is particularly important due to their higher potential of malignancy. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Wound Endoscopical, Colon, After Polyp Resection, Colon
- What is being tested?
- use of EndoClot
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 5 sitesGermany
- Study dates
- 18 Aug 2021to 27 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients with a ≥20mm colon non-pedunculated polyp who are undergoing an ESD or EMR resection
- signed Informed Consent
Who cannot join
- Patients with known (biopsy proven) or strongly suspected invasive carcinoma in a potential study polyp
- Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- ulcerated depressed lesions (as defined by Paris Classification type III)
- polyposis syndromes
- inflammatory bowel disease
- emergency colonoscopy
Show all 11Show fewer
- Poor general health (ASA (American Society of Anaesthesiologists) class>3)
- Patients with coagulopathy with an elevated International Normalized Ratio (INR )≥1.5, or platelets <50
- Poor bowel preparation
- pregnancy or breastfeeding
- Intervention planned using ORISE™ (Boston Medical) or LIFTUP™ (Ovesco) as lifting agents
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Vivantes Auguste-Viktoria-Klinikum
Berlin, 12099
University Hospital Hamburg Eppendorf
Hamburg, 20246
Evangelisches Amalie Sieveking Krankenhaus
Hamburg, 22359
UKGM Marburg, Klinik für Gastroenterologie
Marburg, 35043
Klinikum Südstadt Rostock
Rostock, 18059
About this study
Official title: Efficacy of EndoClot™ Spraying After Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.
The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Effective and safe resection of larger polyps is particularly important due to their higher potential of malignancy. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) (and occasionally endoscopic submucosal dissection (ESD)) 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 2-10% of patients. In a recent randomized trial, clipping has been shown to reduce bleeding esp. on the right colonic side. However, clipping of larger areas is time consuming and may add to costs in several ways.
Our primary aim is to examine whether EndoClot™ application (a special form of longer lasting spray on the mucosal defect after EMR/ESD of large non-pedunculated colorectal polyps (≥20mm) will reduce the risk of delayed bleeding. We hypothesize that EndoClot™ application will reduce the risk of delayed bleeding by at least 3/4 (i.e. from 7.5% to 1.5%) based on an initial assumption of a 7.5% delayed bleeding rate.
Read the detailed description
Colorectal cancer is the second most common cause of cancer death in the United States and Europe. The effectiveness of colonoscopy in reducing the risk of dying from colorectal cancer relies on the detection and safe resection of neoplastic polyps to prevent incident cancers. Most polyps are small and can be easily removed using snare with or without electrocautery. Because the risk of prevalent cancer or transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important.
Endoscopic mucosal resection (EMR) is evolving as the primary endoscopic technique to remove large non-pedunculated polyps. These flat or sessile polyps are defined as lateral spreading tumors with a low vertical axis that extend laterally along the luminal wall. Several mostly retrospective studies from Europe, the U.S. and Japan, have demonstrated a high "cure" rate, with results lending credence to the shift from surgical resection to endoscopic management of these lesions. Of concern, however, is 1) a fairly high overall complication rate of 8-26% in prospective studies3-7, and 2) as well the persistence of residual neoplasia on follow-up endoscopy ranging from 16% to 46%3, 6, 8. The former is the main topic of the present study.
Severe complications including bleeding associated with a standard diagnostic or screening colonoscopy, which may include resection of predominantly smaller polyps, are uncommon. Significant bleeding occurs in 0.2 to 0.5% of patients (defined as a 2mg drop in Hemoglobin) 9, 10. The risk of severe complications increases with polyp size; here, again, the most common complication is bleeding reported in 2 to 24% of polyp resections. In one recent analysis the rate of delayed bleeding in colonic EMR was 7.5%1.
In addition to size, other factors may affect complications. These include type of resection (piecemeal versus en-bloc), polyp location (right colon with a thinner wall than the left colon), age and comorbidities, especially those that affect clotting abilities (e.g. renal insufficiency, liver disease, use of anticoagulation). Studies that have examined variables, which may directly decrease the risk of complications associated with large polyp resection, are limited.
It is apparent that resection of a large polyp leaves behind a large mucosal defect. The mucosal ulcer that forms after polyp resection can take several weeks to heal. Bleeding complications typically occur within 7 to 10 days, requiring often admission, a repeat colonoscopy to stop bleeding, and possible blood transfusions. The rates depend on size, and have been shown to be around 1.5%-2.6% overall. It is significantly higher in larger adenomas of 2 cm and more, namely 6.5% in another recent meta analysis.
To reduce the risk of bleeding various measures have been proposed which also have been summarized in several recent meta analyses. These include coagulation, clipping and others, but only few randomized trials are available: Coagulation not effective in a recent meta analysis14, but only 4 of the 12 studies were randomized and these included all mostly smaller polyps or polyps of all sizes or pedunculated polyps. In a recent randomized trial, clipping has been shown to reduce bleeding esp. on the right colonic side. However, clipping of larger areas is time consuming and may add to costs in several ways.
Our primary aim is to examine whether EndoClot™ application (a special form of longer lasting spray on the mucosal defect after EMR/ESD of large non-pedunculated colorectal polyps (≥20mm) will reduce the risk of delayed bleeding. We hypothesize that EndoClot™ application will reduce the risk of delayed bleeding by at least 3/4 (i.e. from 7.5% to 1.5%) based on an initial assumption of a 7.5% delayed bleeding rate.
- Being tested
- use of EndoClot
- Keywords
- colon endoscopic mucosa resection (EMR), delayed bleeding, colonoscopy, polyp resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of EndoClotProcedure or surgery
deployment of EndoClot adhesive spray
| Study group | Role | What they receive |
|---|---|---|
| EndoClot group | Active comparator | patients who are being provided with EndoClot adhesive spray after polyp resection Receives: Procedure: use of EndoClot |
| Control group | Sham comparator | no further prophylactic bleeding prevention after polyp resection Receives: Procedure: use of EndoClot |
What is being measured
The primary outcome is the main question the study is designed to answer.
delayed bleeding complication: hospitalization
hospitalization after subsequent return to unit / health care facility for evaluation of rectal bleeding
Measured: 30 days
delayed bleeding complication: transfusion
a patient who subsequently had to return to the unit and/or any health care facility for evaluation of rectal bleeding AND who required transfusion
Measured: 30 days
delayed bleeding complication: repeat endoscopy
a patient who subsequently had to return to the unit and/or any health care facility for evaluation of rectal bleeding AND who required a repeat colonoscopy or sigmoidoscopy for examination of the polypectomy site or control of bleeding
Measured: 30 days
delayed bleeding complication:
a patient who subsequently had to return to the unit and/or any health care facility for evaluation of rectal bleeding AND who required surgery
Measured: 30 days
Secondary outcomes (7)
Technical handling
product deployment assumed quantity of entire vial: < 50%/50-70%/100%
Measured: 20 minutes (assumed deployment time)
Overall complications
an aggregate of all complications that occur at the time of the procedure or during follow-up
Measured: procedure to day 30
Factors associated with complications: polyp size
Factors that may be associated with complications, esp. bleeding
Measured: 30 days
Factors associated with complications: polyp location
Factors that may be associated with complications, esp. bleeding: location of the polyp in the colon (right, left, rectum)
Measured: 30 days
Factors associated with complications: polyp histology
Factors that may be associated with complications, esp. bleeding
Measured: 30 days
Factors associated with complications: polyp morphology
Factors that may be associated with complications, esp. bleeding
Measured: 30 days
Factors associated with complications: polyp resection time
Factors that may be associated with complications, esp. bleeding
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 posted1 Sep 2021
- Study start18 Aug 2021
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Why it stopped: insufficient recruitment of study patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Wound Endoscopical, ColonStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- use of EndoClot adhesive after resection vs no use of any preventive action against delayed bleeding (control group)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029934
- Sponsor's protocol ID
- PV7200
- Acronym
- EndoClot™
- Status last verified
- Jul 2023
- First submitted
- 29 Aug 2021
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 30885778Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
PubMed 19474385Brooker 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 11868011Conio M, Repici A, Demarquay JF, Blanchi S, Dumas R, Filiberti R. EMR of large sessile colorectal polyps. Gastrointest Endosc. 2004 Aug;60(2):234-41. doi: 10.1016/s0016-5107(04)01567-6.
PubMed 15278051Ferrara F, Luigiano C, Ghersi S, Fabbri C, Bassi M, Landi P, Polifemo AM, Billi P, Cennamo V, Consolo P, Alibrandi A, D'Imperio N. Efficacy, safety and outcomes of 'inject and cut' endoscopic mucosal resection for large sessile and flat colorectal polyps. Digestion. 2010;82(4):213-20. doi: 10.1159/000284397. Epub 2010 Jun 24.
PubMed 20588036Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Chen RY, Byth K. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology. 2011 Jun;140(7):1909-18. doi: 10.1053/j.gastro.2011.02.062. Epub 2011 Mar 8.
PubMed 21392504Swan MP, Bourke MJ, Alexander S, Moss A, Williams SJ. Large refractory colonic polyps: is it time to change our practice? A prospective study of the clinical and economic impact of a tertiary referral colonic mucosal resection and polypectomy service (with videos). Gastrointest Endosc. 2009 Dec;70(6):1128-36. doi: 10.1016/j.gie.2009.05.039. Epub 2009 Sep 12.
PubMed 19748615Arebi N, Swain D, Suzuki N, Fraser C, Price A, Saunders BP. Endoscopic mucosal resection of 161 cases of large sessile or flat colorectal polyps. Scand J Gastroenterol. 2007 Jul;42(7):859-66. doi: 10.1080/00365520601137280.
PubMed 17558911Levin TR, Zhao W, Conell C, Seeff LC, Manninen DL, Shapiro JA, Schulman J. Complications of colonoscopy in an integrated health care delivery system. Ann Intern Med. 2006 Dec 19;145(12):880-6. doi: 10.7326/0003-4819-145-12-200612190-00004.
PubMed 17179057Ko CW, Riffle S, Michaels L, Morris C, Holub J, Shapiro JA, Ciol MA, Kimmey MB, Seeff LC, Lieberman D. Serious complications within 30 days of screening and surveillance colonoscopy are uncommon. Clin Gastroenterol Hepatol. 2010 Feb;8(2):166-73. doi: 10.1016/j.cgh.2009.10.007. Epub 2009 Oct 20.
PubMed 19850154Reumkens A, Rondagh EJ, Bakker CM, Winkens B, Masclee AA, Sanduleanu S. Post-Colonoscopy Complications: A Systematic Review, Time Trends, and Meta-Analysis of Population-Based Studies. Am J Gastroenterol. 2016 Aug;111(8):1092-101. doi: 10.1038/ajg.2016.234. Epub 2016 Jun 14.
PubMed 27296945Jaruvongvanich V, Prasitlumkum N, Assavapongpaiboon B, Suchartlikitwong S, Sanguankeo A, Upala S. Risk factors for delayed colonic post-polypectomy bleeding: a systematic review and meta-analysis. Int J Colorectal Dis. 2017 Oct;32(10):1399-1406. doi: 10.1007/s00384-017-2870-0. Epub 2017 Aug 5.
PubMed 28779355Hassan C, Repici A, Sharma P, Correale L, Zullo A, Bretthauer M, Senore C, Spada C, Bellisario C, Bhandari P, Rex DK. Efficacy and safety of endoscopic resection of large colorectal polyps: a systematic review and meta-analysis. Gut. 2016 May;65(5):806-20. doi: 10.1136/gutjnl-2014-308481. Epub 2015 Feb 13.
PubMed 25681402Boumitri C, Mir FA, Ashraf I, Matteson-Kome ML, Nguyen DL, Puli SR, Bechtold ML. Prophylactic clipping and post-polypectomy bleeding: a meta-analysis and systematic review. Ann Gastroenterol. 2016 Oct-Dec;29(4):502-508. doi: 10.20524/aog.2016.0075. Epub 2016 Jul 28.
PubMed 27708518ASGE Standards of Practice Committee; Anderson MA, Ben-Menachem T, Gan SI, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Lichtenstein DR, Maple JT, Shen B, Strohmeyer L, Baron T, Dominitz JA. Management of antithrombotic agents for endoscopic procedures. Gastrointest Endosc. 2009 Dec;70(6):1060-70. doi: 10.1016/j.gie.2009.09.040. Epub 2009 Nov 3. No abstract available.
PubMed 19889407
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of EndoClot™ Spraying After Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.
- ClinicalTrials.gov ID
- NCT05029934
- Acronym / sponsor ID
- EndoClot™ / PV7200
- Keywords
- colon endoscopic mucosa resection (EMR), delayed bleeding, colonoscopy, polyp resection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment of study patients
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
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. Effective and safe resection of larger polyps is particularly important due to their higher potential of malignancy. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) (and occasionally endoscopic submucosal dissection (ESD)) 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 2-10% of patients. In a recent randomized trial, clipping has been shown to reduce bleeding esp. on the right colonic side. However, clipping of larger areas is time consuming and may add to costs in several ways.
Our primary aim is to examine whether EndoClot™ application (a special form of longer lasting spray on the mucosal defect after EMR/ESD of large non-pedunculated colorectal polyps (≥20mm) will reduce the risk of delayed bleeding. We hypothesize that EndoClot™ application will reduce the risk of delayed bleeding by at least 3/4 (i.e. from 7.5% to 1.5%) based on an initial assumption of a 7.5% delayed bleeding rate.
Detailed description
Colorectal cancer is the second most common cause of cancer death in the United States and Europe. The effectiveness of colonoscopy in reducing the risk of dying from colorectal cancer relies on the detection and safe resection of neoplastic polyps to prevent incident cancers. Most polyps are small and can be easily removed using snare with or without electrocautery. Because the risk of prevalent cancer or transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important.
Endoscopic mucosal resection (EMR) is evolving as the primary endoscopic technique to remove large non-pedunculated polyps. These flat or sessile polyps are defined as lateral spreading tumors with a low vertical axis that extend laterally along the luminal wall. Several mostly retrospective studies from Europe, the U.S. and Japan, have demonstrated a high "cure" rate, with results lending credence to the shift from surgical resection to endoscopic management of these lesions. Of concern, however, is 1) a fairly high overall complication rate of 8-26% in prospective studies3-7, and 2) as well the persistence of residual neoplasia on follow-up endoscopy ranging from 16% to 46%3, 6, 8. The former is the main topic of the present study.
Severe complications including bleeding associated with a standard diagnostic or screening colonoscopy, which may include resection of predominantly smaller polyps, are uncommon. Significant bleeding occurs in 0.2 to 0.5% of patients (defined as a 2mg drop in Hemoglobin) 9, 10. The risk of severe complications increases with polyp size; here, again, the most common complication is bleeding reported in 2 to 24% of polyp resections. In one recent analysis the rate of delayed bleeding in colonic EMR was 7.5%1.
In addition to size, other factors may affect complications. These include type of resection (piecemeal versus en-bloc), polyp location (right colon with a thinner wall than the left colon), age and comorbidities, especially those that affect clotting abilities (e.g. renal insufficiency, liver disease, use of anticoagulation). Studies that have examined variables, which may directly decrease the risk of complications associated with large polyp resection, are limited.
It is apparent that resection of a large polyp leaves behind a large mucosal defect. The mucosal ulcer that forms after polyp resection can take several weeks to heal. Bleeding complications typically occur within 7 to 10 days, requiring often admission, a repeat colonoscopy to stop bleeding, and possible blood transfusions. The rates depend on size, and have been shown to be around 1.5%-2.6% overall. It is significantly higher in larger adenomas of 2 cm and more, namely 6.5% in another recent meta analysis.
To reduce the risk of bleeding various measures have been proposed which also have been summarized in several recent meta analyses. These include coagulation, clipping and others, but only few randomized trials are available: Coagulation not effective in a recent meta analysis14, but only 4 of the 12 studies were randomized and these included all mostly smaller polyps or polyps of all sizes or pedunculated polyps. In a recent randomized trial, clipping has been shown to reduce bleeding esp. on the right colonic side. However, clipping of larger areas is time consuming and may add to costs in several ways.
Our primary aim is to examine whether EndoClot™ application (a special form of longer lasting spray on the mucosal defect after EMR/ESD of large non-pedunculated colorectal polyps (≥20mm) will reduce the risk of delayed bleeding. We hypothesize that EndoClot™ application will reduce the risk of delayed bleeding by at least 3/4 (i.e. from 7.5% to 1.5%) based on an initial assumption of a 7.5% delayed bleeding rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- use of EndoClot adhesive after resection vs no use of any preventive action against delayed bleeding (control group)
| Arm | Type | Receives |
|---|---|---|
| EndoClot group | Active comparator | Procedure: use of EndoClotpatients who are being provided with EndoClot adhesive spray after polyp resection |
| Control group | Sham comparator | Procedure: use of EndoClotno further prophylactic bleeding prevention after polyp resection |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a ≥20mm colon non-pedunculated polyp who are undergoing an ESD or EMR resection
- signed Informed Consent
Key exclusion criteria (11 listed)
- Patients with known (biopsy proven) or strongly suspected invasive carcinoma in a potential study polyp
- Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
- ulcerated depressed lesions (as defined by Paris Classification type III)
- polyposis syndromes
- inflammatory bowel disease
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 |
|---|---|---|
| use of EndoClotdeployment of EndoClot adhesive spray | Procedure or surgery | Control group, EndoClot group |
Primary outcome
delayed bleeding complication: hospitalization
Time frame: 30 days
hospitalization after subsequent return to unit / health care facility for evaluation of rectal bleeding
delayed bleeding complication: transfusion
Time frame: 30 days
a patient who subsequently had to return to the unit and/or any health care facility for evaluation of rectal bleeding AND who required transfusion
delayed bleeding complication: repeat endoscopy
Time frame: 30 days
a patient who subsequently had to return to the unit and/or any health care facility for evaluation of rectal bleeding AND who required a repeat colonoscopy or sigmoidoscopy for examination of the polypectomy site or control of bleeding
delayed bleeding complication:
Time frame: 30 days
a patient who subsequently had to return to the unit and/or any health care facility for evaluation of rectal bleeding AND who required surgery
7 secondary outcomes
Technical handling
Time frame: 20 minutes (assumed deployment time)
Overall complications
Time frame: procedure to day 30
Factors associated with complications: polyp size
Time frame: 30 days
Factors associated with complications: polyp location
Time frame: 30 days
Factors associated with complications: polyp histology
Time frame: 30 days
Factors associated with complications: polyp morphology
Time frame: 30 days
Factors associated with complications: polyp resection time
Time frame: 30 days
Results and safety
The study was stopped early (reason given: insufficient recruitment of study patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Background: 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.
- Background: PubMed 19474385Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27.
- 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 15278051Conio M, Repici A, Demarquay JF, Blanchi S, Dumas R, Filiberti R. EMR of large sessile colorectal polyps. Gastrointest Endosc. 2004 Aug;60(2):234-41. doi: 10.1016/s0016-5107(04)01567-6.
- Background: PubMed 20588036Ferrara F, Luigiano C, Ghersi S, Fabbri C, Bassi M, Landi P, Polifemo AM, Billi P, Cennamo V, Consolo P, Alibrandi A, D'Imperio N. Efficacy, safety and outcomes of 'inject and cut' endoscopic mucosal resection for large sessile and flat colorectal polyps. Digestion. 2010;82(4):213-20. doi: 10.1159/000284397. Epub 2010 Jun 24.
- Background: PubMed 21392504Moss A, Bourke MJ, Williams SJ, Hourigan LF, Brown G, Tam W, Singh R, Zanati S, Chen RY, Byth K. Endoscopic mucosal resection outcomes and prediction of submucosal cancer from advanced colonic mucosal neoplasia. Gastroenterology. 2011 Jun;140(7):1909-18. doi: 10.1053/j.gastro.2011.02.062. Epub 2011 Mar 8.
- Background: PubMed 19748615Swan MP, Bourke MJ, Alexander S, Moss A, Williams SJ. Large refractory colonic polyps: is it time to change our practice? A prospective study of the clinical and economic impact of a tertiary referral colonic mucosal resection and polypectomy service (with videos). Gastrointest Endosc. 2009 Dec;70(6):1128-36. doi: 10.1016/j.gie.2009.05.039. Epub 2009 Sep 12.
- Background: PubMed 17558911Arebi N, Swain D, Suzuki N, Fraser C, Price A, Saunders BP. Endoscopic mucosal resection of 161 cases of large sessile or flat colorectal polyps. Scand J Gastroenterol. 2007 Jul;42(7):859-66. doi: 10.1080/00365520601137280.
- Background: PubMed 17179057Levin TR, Zhao W, Conell C, Seeff LC, Manninen DL, Shapiro JA, Schulman J. Complications of colonoscopy in an integrated health care delivery system. Ann Intern Med. 2006 Dec 19;145(12):880-6. doi: 10.7326/0003-4819-145-12-200612190-00004.
- Background: PubMed 19850154Ko CW, Riffle S, Michaels L, Morris C, Holub J, Shapiro JA, Ciol MA, Kimmey MB, Seeff LC, Lieberman D. Serious complications within 30 days of screening and surveillance colonoscopy are uncommon. Clin Gastroenterol Hepatol. 2010 Feb;8(2):166-73. doi: 10.1016/j.cgh.2009.10.007. Epub 2009 Oct 20.
- Background: PubMed 27296945Reumkens A, Rondagh EJ, Bakker CM, Winkens B, Masclee AA, Sanduleanu S. Post-Colonoscopy Complications: A Systematic Review, Time Trends, and Meta-Analysis of Population-Based Studies. Am J Gastroenterol. 2016 Aug;111(8):1092-101. doi: 10.1038/ajg.2016.234. Epub 2016 Jun 14.
- Background: PubMed 28779355Jaruvongvanich V, Prasitlumkum N, Assavapongpaiboon B, Suchartlikitwong S, Sanguankeo A, Upala S. Risk factors for delayed colonic post-polypectomy bleeding: a systematic review and meta-analysis. Int J Colorectal Dis. 2017 Oct;32(10):1399-1406. doi: 10.1007/s00384-017-2870-0. Epub 2017 Aug 5.
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of EndoClot in people with Wound Endoscopical, Colon and After Polyp Resection, Colon, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in Germany.
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 11 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: stopped early, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: insufficient recruitment of study patients). Results are not available in the source record.
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?
delayed bleeding complication: hospitalization (time frame: 30 days). The study lists 4 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 NCT05029934, which also lists 18 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 Jul 2023.