Postpolypectomy BleedingNCT01565993
The Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps
A study testing Hemoclip and Conventional Polipectomy in people with Postpolypectomy Bleeding, run by Hospital Severo Ochoa at 1 site in Spain.
Trial summary
The aim of our study is to analyze the advantages of the prophylactic use of hemoclips before polypectomy in our usual clinical practice, through a prospective randomized study that determines their effectiveness compared to conventional polypectomy, assessing the decrease in immediate and delayed post-polypectomy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postpolypectomy Bleeding
- What is being tested?
- Hemoclip and Conventional Polipectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2007to Aug 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with one or more pedunculated polyps, the heads of which measured more than 1cm (regardless of the stalk thickness and length), and they were compared against the size of the biopsy forceps (6mm) and subsequently confirmed in the anatomical specimen
- Not to have any hemostatic alterations at the time the endoscopy was performed (confirmed by the usual blood tests taken before the procedure).
Who cannot join
- Patients younger than 18 years of age
- Patients with a platelet count of less than 50000, INR larger than 1.5
- Patients who refused to give their informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps Useful? A Prospective and Randomized Study
The aim of our study is to analyze the advantages of the prophylactic use of hemoclips before polypectomy in our usual clinical practice, through a prospective randomized study that determines their effectiveness compared to conventional polypectomy, assessing the decrease in immediate and delayed post-polypectomy bleeding
Read the detailed description
The methods for preventing post-polypectomy bleeding (PPB) are not standardised and there are groups that use hemoclips for this purpose.
The aim of our study is to analyze whether the use of hemoclips reduces PPB complications. It is a prospective, randomised study of patients with pedunculated polyps larger than 10mm. The patients were included in two groups (hemoclip before polypectomy -HC- and standard polypectomy -SP-)
- Conditions
- Postpolypectomy Bleeding
- Being tested
- Hemoclip, Conventional Polipectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoclipDevice
A rotatable clip-fixing device "Quickclip 2" standard was used (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan), with an opening diameter of 135º and a maximum insertion portion diameter of 2.6 mm
Conventional PolipectomyDevice
Disposable electrosurgical snares (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan) and an electrosurgery unit ERBE (ERBE Elektromedizin GmbH, Germany) were used for polyp resection
| Study group | Role | What they receive |
|---|---|---|
| Hemoclip | Active comparator | In group HEMOCLIP, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop Receives: Device: Hemoclip |
| Conventional Polipectomy | Active comparator | In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique Receives: Device: Conventional Polipectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)
In order to test the ability of prophylactic hemoclipping to prevent post-polypectomy bleeding, the investigators were required to register all the adverse events that occurred. These adverse events were called "complications", despite their severity and clinical significance
Measured: Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding
Secondary outcomes (1)
Difficult to Place the Clip
The hemoclips which were incorrectly placed, mainly because the pedicles were very thick and/or short.
Measured: During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startJul 2007
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: The unexpected increase in morbidity of the hemoclip group
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 (2)Papers the sponsor has linked to this study.
- Other trials for Postpolypectomy BleedingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Severo Ochoa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elvira Quintanilla, Hospital Severo Ochoa
- Investigators
- Elvira M Quintanilla, MD, Principal investigator, Hospital Severo OchoaLuis R Rábago, PhD, Study director, Hospital Severo Ochoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565993
- Sponsor's protocol ID
- EQCLIPS
- Status last verified
- Apr 2012
- First submitted
- 27 Mar 2012
- Last updated
- 25 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Quintanilla E, Castro JL, Rabago LR, Chico I, Olivares A, Ortega A, Vicente C, Carbo J, Gea F. Is the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps useful? A prospective and randomized study. J Interv Gastroenterol. 2012 Oct;2(4):183-188. doi: 10.4161/jig.23741. Epub 2012 Oct 1.
PubMed 23687606Quintanilla E, Castro JL, Rabago LR, Chico I, Olivares A, Ortega A, Vicente C, Carbo J, Gea F. Is the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps useful? A prospective and randomized study. J Interv Gastroenterol. 2012 Apr;2(2):99-104. doi: 10.4161/jig.22210. Epub 2012 Apr 1.
PubMed 23687598
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Use of Prophylactic Hemoclips in the Endoscopic Resection of Large Pedunculated Polyps Useful? A Prospective and Randomized Study
- ClinicalTrials.gov ID
- NCT01565993
- Acronym / sponsor ID
- EQCLIPS
- Conditions
- Postpolypectomy Bleeding
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The unexpected increase in morbidity of the hemoclip group
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Hospital Severo OchoaUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Posted 25 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of our study is to analyze the advantages of the prophylactic use of hemoclips before polypectomy in our usual clinical practice, through a prospective randomized study that determines their effectiveness compared to conventional polypectomy, assessing the decrease in immediate and delayed post-polypectomy bleeding
Detailed description
The methods for preventing post-polypectomy bleeding (PPB) are not standardised and there are groups that use hemoclips for this purpose.
The aim of our study is to analyze whether the use of hemoclips reduces PPB complications. It is a prospective, randomised study of patients with pedunculated polyps larger than 10mm. The patients were included in two groups (hemoclip before polypectomy -HC- and standard polypectomy -SP-)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemoclip | Active comparator | Device: HemoclipIn group HEMOCLIP, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop |
| Conventional Polipectomy | Active comparator | Device: Conventional PolipectomyIn group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with one or more pedunculated polyps, the heads of which measured more than 1cm (regardless of the stalk thickness and length), and they were compared against the size of the biopsy forceps (6mm) and subsequently confirmed in the anatomical specimen
- Not to have any hemostatic alterations at the time the endoscopy was performed (confirmed by the usual blood tests taken before the procedure).
Key exclusion criteria (3 listed)
- Patients younger than 18 years of age
- Patients with a platelet count of less than 50000, INR larger than 1.5
- Patients who refused to give their informed consent.
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 |
|---|---|---|
| HemoclipA rotatable clip-fixing device "Quickclip 2" standard was used (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan), with an opening diameter of 135º and a maximum insertion portion diameter of 2.6 mm | Device | Hemoclip |
| Conventional PolipectomyDisposable electrosurgical snares (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan) and an electrosurgery unit ERBE (ERBE Elektromedizin GmbH, Germany) were used for polyp resection | Device | Conventional Polipectomy |
Primary outcome
The Number of Polyps With Complications After Polypectomy (The Total Complication Rate)
Time frame: Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding
In order to test the ability of prophylactic hemoclipping to prevent post-polypectomy bleeding, the investigators were required to register all the adverse events that occurred. These adverse events were called "complications", despite their severity and clinical significance
1 secondary outcome
Difficult to Place the Clip
Time frame: During endoscopic procedure was performed (between 2007 and 2010: period over which the study was conducted)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23687606Quintanilla E, Castro JL, Rabago LR, Chico I, Olivares A, Ortega A, Vicente C, Carbo J, Gea F. Is the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps useful? A prospective and randomized study. J Interv Gastroenterol. 2012 Oct;2(4):183-188. doi: 10.4161/jig.23741. Epub 2012 Oct 1.
- Derived from this study: PubMed 23687598Quintanilla E, Castro JL, Rabago LR, Chico I, Olivares A, Ortega A, Vicente C, Carbo J, Gea F. Is the use of prophylactic hemoclips in the endoscopic resection of large pedunculated polyps useful? A prospective and randomized study. J Interv Gastroenterol. 2012 Apr;2(2):99-104. doi: 10.4161/jig.22210. Epub 2012 Apr 1.
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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.
Elvira M Quintanilla, MD principal investigator
Hospital Severo Ochoa
Luis R Rábago, PhD study director
Hospital Severo Ochoa
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 Conventional Polipectomy in people with Postpolypectomy Bleeding, run by Hospital Severo Ochoa at 1 site in Spain.
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 3 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 25 May 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 Spain. 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 25 May 2012). 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?
The Number of Polyps With Complications After Polypectomy (The Total Complication Rate) (time frame: Between four and six weeks after the polypectomy, the patients were contacted by phone in order to confirm the absence of delayed bleeding). 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 NCT01565993, which also lists 2 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 25 May 2012.