Endoscopic HemostasisEMRNCT01496781
EndoClot for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection
A study testing Hemoclip and EndoClot in people with Endoscopic Hemostasis and Colonic Polyps, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Para-procedure bleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use including metallic hemoclip. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endoscopic Hemostasis, Colonic Polyps
- What is being tested?
- Hemoclip and EndoClot
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- Apr 2010to Mar 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consecutive cases of colorectal polyps and submucosal tumors with anticipated complete removal endoscopically by EMR.
Who cannot join
- severe cardiovascular diseases, liver and kidney dysfunction;
- platelet and coagulation dysfunction (PLT < 50*109/L, INR > 2);
- cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure;
- cases unavailable for follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EndoClotTM Absorbable Polysaccharide Hemostat in Comparison With Metallic Hemoclip for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection: a Prospective, Randomized Trial
Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Para-procedure bleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use including metallic hemoclip. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This randomized controlled study has been designed to compare PAPH with metallic hemoclip in their hemostatic effect of intra-procedure bleeding control and rebleeding prevention during and after EMR.
- Conditions
- Endoscopic Hemostasis, Colonic Polyps
- Being tested
- Hemoclip, EndoClot
- Keywords
- Endoscopic Hemostasis, metallic hemoclip, EndoClot Absorbable Polysaccharide Hemostat, Colonic Polyps
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoclipProcedure or surgery
Also called metallic hemoclip (Cat# HX-610-090L, Olympus)
Hemoclip application is a standard treatment option after endoscopic mucosal resection of colonic lesion to stop and prevent post-procedure bleeding.
EndoClotProcedure or surgery
Also called EndoClot® Absorbable Polysaccharide Hemostat (Cat# Y2007090722, Starch Medical Inc)
EndoClot hemostat is applied immediately after EMR to achieve hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| EndoClot | Experimental | This arm is designed to observe if the Endoclot treatment can achieve comparable hemostasis efficacy compared with hemoclip. Receives: Procedure: EndoClot |
| Hemoclip | Active comparator | This arm is used as a control treatment group to compare with Endoclot treatment. Receives: Procedure: Hemoclip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis rate after EMR
Initial hemostatsis was observed endoscopically immediately after application of hemoclip or Endoclot. Complete hemostatsis is ensured. Endoscopic combined hemostasis or emergency surgery would be applied if severe bleeding occurred and endoscopic management fails
Measured: Up to half an hour immediately after EMR procedure to ensure successful management is achieved.
Secondary outcomes (4)
Mucosal healing after EMR
Colonoscopy will be repeated 1 month after EMR procedure to observe if application of Endoclot will delay the musosal healing.
Measured: up to 1 month
Time taken to achieve hemostasis
The time taken to achieve hemostasis is recorded immediately after EMR procedure to reflect the technical difficulty of hemostasis measure.
Measured: Up to half an hour immediately after EMR procedure to ensure successful management is achieved.
Rebleeding rate after EMR procedure
Rebleeding rate up to 1 week was obtained by clinical manifestations such as melana; decreased hemoglobin > 20g/L; hemodynamic instability or active bleeding from mucosal defect under endoscope.
Measured: up to 1 week
gastrointestinal tract obstruction
Gastrointestinal tract obstruction has been previously reported as a possible adverse effect of hemostats, therefore it was observed in the current study.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startApr 2010
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Endoscopic HemostasisStudies 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
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Liu, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496781
- Sponsor's protocol ID
- 20111219
- Acronym
- EMR
- Status last verified
- Apr 2012
- First submitted
- 19 Dec 2011
- Last updated
- 17 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parra-Blanco A, Kaminaga N, Kojima T, Endo Y, Uragami N, Okawa N, Hattori T, Takahashi H, Fujita R. Hemoclipping for postpolypectomy and postbiopsy colonic bleeding. Gastrointest Endosc. 2000 Jan;51(1):37-41. doi: 10.1016/s0016-5107(00)70384-1.
PubMed 10625793Lin LF, Siauw CP, Ho KS, Tung JC. Endoscopic hemoclip treatment of gastrointestinal bleeding. Chang Gung Med J. 2001 May;24(5):307-12.
PubMed 11480327Binmoeller KF, Thonke F, Soehendra N. Endoscopic hemoclip treatment for gastrointestinal bleeding. Endoscopy. 1993 Feb;25(2):167-70. doi: 10.1055/s-2007-1010277.
PubMed 8491134Katsinelos P, Paroutoglou G, Beltsis A, Papaziogas B, Gouvalas A, Chatzimavroudis G, Vlachakis I, Mimidis K, Vradelis S, Pilpilidis I. Endoscopic hemoclip application in the treatment of nonvariceal gastrointestinal bleeding: short-term and long-term benefits. Surg Laparosc Endosc Percutan Tech. 2005 Aug;15(4):187-90. doi: 10.1097/01.sle.0000174575.52840.23.
PubMed 16082303Kouklakis G, Mpoumponaris A, Gatopoulou A, Efraimidou E, Manolas K, Lirantzopoulos N. Endoscopic resection of large pedunculated colonic polyps and risk of postpolypectomy bleeding with adrenaline injection versus endoloop and hemoclip: a prospective, randomized study. Surg Endosc. 2009 Dec;23(12):2732-7. doi: 10.1007/s00464-009-0478-3. Epub 2009 May 9.
PubMed 19430833Wang Y, Xu M, Dong H, Liu Y, Zhao P, Niu W, Xu D, Ji X, Xing C, Lu D, Li Z. Effects of PerClot(R) on the healing of full-thickness skin wounds in rats. Acta Histochem. 2012 Jul;114(4):311-7. doi: 10.1016/j.acthis.2011.06.012. Epub 2011 Jul 22.
PubMed 21782216
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EndoClotTM Absorbable Polysaccharide Hemostat in Comparison With Metallic Hemoclip for Hemostasis and Preventing Post-procedure Bleeding After Endoscopic Mucosal Resection: a Prospective, Randomized Trial
- ClinicalTrials.gov ID
- NCT01496781
- Acronym / sponsor ID
- EMR / 20111219
- Conditions
- Endoscopic Hemostasis, Colonic Polyps
- Keywords
- Endoscopic Hemostasis, metallic hemoclip, EndoClot Absorbable Polysaccharide Hemostat, Colonic Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Dec 2011 (estimated)
- 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.
Endoscopic mucosal resection (EMR) has been widely used as a diagnostic and treatment techniques of gastrointestinal small lesions. Para-procedure bleeding is one of the common complication following EMR. Several endoscopic hemostasis methods are currently in use including metallic hemoclip. EndoClot® absorbable polysaccharide hemostat (PAPH) as a new hemostasis material was previously used for surgical hemostasis, but the therapeutic effect and safety in endoscopic application remains unknown. This randomized controlled study has been designed to compare PAPH with metallic hemoclip in their hemostatic effect of intra-procedure bleeding control and rebleeding prevention during and after EMR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EndoClot | Experimental | Procedure: EndoClotThis arm is designed to observe if the Endoclot treatment can achieve comparable hemostasis efficacy compared with hemoclip. |
| Hemoclip | Active comparator | Procedure: HemoclipThis arm is used as a control treatment group to compare with Endoclot treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive cases of colorectal polyps and submucosal tumors with anticipated complete removal endoscopically by EMR.
Key exclusion criteria (4 listed)
- severe cardiovascular diseases, liver and kidney dysfunction;
- platelet and coagulation dysfunction (PLT < 50*109/L, INR > 2);
- cases that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 1 month before the procedure;
- cases unavailable for follow-up.
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 |
|---|---|---|
| HemoclipAlso: metallic hemoclip (Cat# HX-610-090L, Olympus)Hemoclip application is a standard treatment option after endoscopic mucosal resection of colonic lesion to stop and prevent post-procedure bleeding. | Procedure or surgery | Hemoclip |
| EndoClotAlso: EndoClot® Absorbable Polysaccharide Hemostat (Cat# Y2007090722, Starch Medical Inc)EndoClot hemostat is applied immediately after EMR to achieve hemostasis. | Procedure or surgery | EndoClot |
Primary outcome
Hemostasis rate after EMR
Time frame: Up to half an hour immediately after EMR procedure to ensure successful management is achieved.
Initial hemostatsis was observed endoscopically immediately after application of hemoclip or Endoclot. Complete hemostatsis is ensured. Endoscopic combined hemostasis or emergency surgery would be applied if severe bleeding occurred and endoscopic management fails
4 secondary outcomes
Mucosal healing after EMR
Time frame: up to 1 month
Time taken to achieve hemostasis
Time frame: Up to half an hour immediately after EMR procedure to ensure successful management is achieved.
Rebleeding rate after EMR procedure
Time frame: up to 1 week
gastrointestinal tract obstruction
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2012.
- Background: PubMed 10625793Parra-Blanco A, Kaminaga N, Kojima T, Endo Y, Uragami N, Okawa N, Hattori T, Takahashi H, Fujita R. Hemoclipping for postpolypectomy and postbiopsy colonic bleeding. Gastrointest Endosc. 2000 Jan;51(1):37-41. doi: 10.1016/s0016-5107(00)70384-1.
- Background: PubMed 11480327Lin LF, Siauw CP, Ho KS, Tung JC. Endoscopic hemoclip treatment of gastrointestinal bleeding. Chang Gung Med J. 2001 May;24(5):307-12.
- Background: PubMed 8491134Binmoeller KF, Thonke F, Soehendra N. Endoscopic hemoclip treatment for gastrointestinal bleeding. Endoscopy. 1993 Feb;25(2):167-70. doi: 10.1055/s-2007-1010277.
- Background: PubMed 16082303Katsinelos P, Paroutoglou G, Beltsis A, Papaziogas B, Gouvalas A, Chatzimavroudis G, Vlachakis I, Mimidis K, Vradelis S, Pilpilidis I. Endoscopic hemoclip application in the treatment of nonvariceal gastrointestinal bleeding: short-term and long-term benefits. Surg Laparosc Endosc Percutan Tech. 2005 Aug;15(4):187-90. doi: 10.1097/01.sle.0000174575.52840.23.
- Background: PubMed 19430833Kouklakis G, Mpoumponaris A, Gatopoulou A, Efraimidou E, Manolas K, Lirantzopoulos N. Endoscopic resection of large pedunculated colonic polyps and risk of postpolypectomy bleeding with adrenaline injection versus endoloop and hemoclip: a prospective, randomized study. Surg Endosc. 2009 Dec;23(12):2732-7. doi: 10.1007/s00464-009-0478-3. Epub 2009 May 9.
- Background: PubMed 21782216Wang Y, Xu M, Dong H, Liu Y, Zhao P, Niu W, Xu D, Ji X, Xing C, Lu D, Li Z. Effects of PerClot(R) on the healing of full-thickness skin wounds in rats. Acta Histochem. 2012 Jul;114(4):311-7. doi: 10.1016/j.acthis.2011.06.012. Epub 2011 Jul 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemoclip and EndoClot in people with Endoscopic Hemostasis and Colonic Polyps, run by Xijing Hospital of Digestive Diseases at 1 site in China.
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 1 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 17 Apr 2012. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hemostasis rate after EMR (time frame: Up to half an hour immediately after EMR procedure to ensure successful management is achieved.). 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 NCT01496781, which also lists 6 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 17 Apr 2012.