Colonic PolypNCT04123080
A Technique Using EBL for Removal of Pedunculated Colon Polyps
A study testing Endoscopic band ligation assisted polypectomy in people with Colonic Polyp, run by Uijeongbu St. Mary Hospital.
Trial summary
Bleeding is the most common complication associated with polypectomy of large pedunculated colonic polyp. Although several techniques have been developed to minimize bleeding, none of these methods has become the gold standard. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- Endoscopic band ligation assisted polypectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2012to 31 Jan 2014
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Polyps with head >10 mm and stalk length >10 mm;
- Location at the distal segments of the colon; and
- Benign features under endoscopic inspection (absence of ulceration and induration or friability).
Who cannot join
- Patients who refuse to sign the consent
About this study
Official title: A Novel Technique Using Endoscopic Band Ligation for Removal of Long-stalked (>10 mm) Pedunculated Colon Polyps
Bleeding is the most common complication associated with polypectomy of large pedunculated colonic polyp. Although several techniques have been developed to minimize bleeding, none of these methods has become the gold standard. To prevent post-polypectomy bleeding effectively, the investigators developed and attempted a new endoscopic technique for removal of large long-stalked pedunculated colonic polyps using band ligations. This study aims to evaluate the safety and efficacy of a novel technique using endoscopic band ligation for removal of long-stalked pedunculated colon polyps.
Read the detailed description
A prospective single-center study was conducted. Targeted polyps were large (head size >10 mm) with long stalk length (>10 mm) in the distal colon. After finding target lesions by standard colonoscopy, conventional upper endoscopy with rubber band (endoscopic band ligation, EBL) was applied to squeeze the mid-portion of the stalk to form an omega shape, which had the dual effect of ligation and compression of feeding blood vessels. After strangulation of the stalk, snare polypectomy was performed at the stalk site just above the ligation. The investigators evaluated several parameters, including completeness of resection, procedure time, and complications, including immediate postpolypectomy bleeding, delayed postpolypectomy bleeding, and perforation.
- Conditions
- Colonic Polyp
- Being tested
- Endoscopic band ligation assisted polypectomy
- Keywords
- Colonic Polyp, Endoscopic mucosal resection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic band ligation assisted polypectomyDevice
A conventional upper endoscope loaded with a band ligator was inserted in the colon and was advanced to the site of the pedunculated polyp. After approaching the lateral side of the stalk and grasping the mid-portion of the stalk using a tripod grasper. Then, the rubber band was released from the cap to ligate the stalk. Thereafter, we performed polypectomy of the remaining stalk just above the ligation by extending the electrosurgical snare.
| Study group | Role | What they receive |
|---|---|---|
| EBL group | Experimental | Removal of large long-stalked pedunculated colonic polyps using band ligations Receives: Device: Endoscopic band ligation assisted polypectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of completed polyp resection
a lesion-free margin with both the lateral and basal tissues free of pathology
Measured: Immediately after the intervention
Procedure time
From approaching the the stalk to snare polypectomy with electrosurgical snare
Measured: during the procedure
Rate of immediate postpolypectomy bleeding
pulsating bleeding or oozing lasting more than 60 s immediately after polypectomy or requiring endoscopic intervention.
Measured: during the procedure
Rate of delayed postpolypectomy bleeding
gross rectal bleeding, bleeding requiring endoscopic or radiological hemostasis, or transfusions requiring surgery
Measured: 30 days after procedure
Rate of perforation
endoscopically observed colonic wall penetration, or perforation detected after endoscopy by radiological examination including abdomen CT.
Measured: 30 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Apr 2012
- Primary completion31 Jan 2014
- Study completion31 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uijeongbu St. Mary Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiun Suk Chae, Uijeongbu St. Mary Hospital
- Investigators
- Hiun-Suk Chae, Professor, Principal investigator, Uijeongbu St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123080
- Sponsor's protocol ID
- UC12RISI0173
- Status last verified
- Oct 2019
- First submitted
- 7 Oct 2019
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fyock CJ, Draganov PV. Colonoscopic polypectomy and associated techniques. World J Gastroenterol. 2010 Aug 7;16(29):3630-7. doi: 10.3748/wjg.v16.i29.3630.
PubMed 20677334Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.
PubMed 28212588Baron TH, Wong Kee Song LM. Endoscopic variceal band ligation. Am J Gastroenterol. 2009 May;104(5):1083-5. doi: 10.1038/ajg.2008.17. No abstract available.
PubMed 19417747Carmo J, Marques S, Chapim I, Barreiro P, Bispo M, Chagas C. Elastic band ligation for the removal of a colonic tubular adenoma in a diverticulum. Endoscopy. 2015;47 Suppl 1 UCTN:E490-1. doi: 10.1055/s-0034-1393142. Epub 2015 Oct 19. No abstract available.
PubMed 26479300
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Technique Using Endoscopic Band Ligation for Removal of Long-stalked (>10 mm) Pedunculated Colon Polyps
- ClinicalTrials.gov ID
- NCT04123080
- Acronym / sponsor ID
- UC12RISI0173
- Conditions
- Colonic Polyp
- Keywords
- Colonic Polyp, Endoscopic mucosal resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Uijeongbu St. Mary HospitalUniversity, hospital or other
- Study start
- 1 Apr 2012 (actual)
- Primary completion
- 31 Jan 2014 (actual)
- Study completion
- 31 Jan 2014 (actual)
- First posted
- 10 Oct 2019 (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.
Bleeding is the most common complication associated with polypectomy of large pedunculated colonic polyp. Although several techniques have been developed to minimize bleeding, none of these methods has become the gold standard. To prevent post-polypectomy bleeding effectively, the investigators developed and attempted a new endoscopic technique for removal of large long-stalked pedunculated colonic polyps using band ligations. This study aims to evaluate the safety and efficacy of a novel technique using endoscopic band ligation for removal of long-stalked pedunculated colon polyps.
Detailed description
A prospective single-center study was conducted. Targeted polyps were large (head size >10 mm) with long stalk length (>10 mm) in the distal colon. After finding target lesions by standard colonoscopy, conventional upper endoscopy with rubber band (endoscopic band ligation, EBL) was applied to squeeze the mid-portion of the stalk to form an omega shape, which had the dual effect of ligation and compression of feeding blood vessels. After strangulation of the stalk, snare polypectomy was performed at the stalk site just above the ligation. The investigators evaluated several parameters, including completeness of resection, procedure time, and complications, including immediate postpolypectomy bleeding, delayed postpolypectomy bleeding, and perforation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBL group | Experimental | Device: Endoscopic band ligation assisted polypectomyRemoval of large long-stalked pedunculated colonic polyps using band ligations |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Polyps with head >10 mm and stalk length >10 mm;
- Location at the distal segments of the colon; and
- Benign features under endoscopic inspection (absence of ulceration and induration or friability).
Key exclusion criteria (1 listed)
- Patients who refuse to sign the 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 |
|---|---|---|
| Endoscopic band ligation assisted polypectomyA conventional upper endoscope loaded with a band ligator was inserted in the colon and was advanced to the site of the pedunculated polyp. After approaching the lateral side of the stalk and grasping the mid-portion of the stalk using a tripod grasper. Then, the rubber band was released from the cap to ligate the stalk. Thereafter, we performed polypectomy of the remaining stalk just above the ligation by extending the electrosurgical snare. | Device | EBL group |
Primary outcome
Rate of completed polyp resection
Time frame: Immediately after the intervention
a lesion-free margin with both the lateral and basal tissues free of pathology
Procedure time
Time frame: during the procedure
From approaching the the stalk to snare polypectomy with electrosurgical snare
Rate of immediate postpolypectomy bleeding
Time frame: during the procedure
pulsating bleeding or oozing lasting more than 60 s immediately after polypectomy or requiring endoscopic intervention.
Rate of delayed postpolypectomy bleeding
Time frame: 30 days after procedure
gross rectal bleeding, bleeding requiring endoscopic or radiological hemostasis, or transfusions requiring surgery
Rate of perforation
Time frame: 30 days after procedure
endoscopically observed colonic wall penetration, or perforation detected after endoscopy by radiological examination including abdomen CT.
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 10 Oct 2019.
- Background: PubMed 20677334Fyock CJ, Draganov PV. Colonoscopic polypectomy and associated techniques. World J Gastroenterol. 2010 Aug 7;16(29):3630-7. doi: 10.3748/wjg.v16.i29.3630.
- Background: PubMed 28212588Ferlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17.
- Background: PubMed 19417747Baron TH, Wong Kee Song LM. Endoscopic variceal band ligation. Am J Gastroenterol. 2009 May;104(5):1083-5. doi: 10.1038/ajg.2008.17. No abstract available.
- Background: PubMed 26479300Carmo J, Marques S, Chapim I, Barreiro P, Bispo M, Chagas C. Elastic band ligation for the removal of a colonic tubular adenoma in a diverticulum. Endoscopy. 2015;47 Suppl 1 UCTN:E490-1. doi: 10.1055/s-0034-1393142. Epub 2015 Oct 19. No abstract available.
- Individual participant dataSharing planned: No
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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.
Hiun-Suk Chae, Professor principal investigator
Uijeongbu St. Mary's Hospital, The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic band ligation assisted polypectomy in people with Colonic Polyp, run by Uijeongbu St. Mary Hospital.
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 3 inclusion and 1 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 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Rate of completed polyp resection (time frame: Immediately after the intervention). The study lists 5 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 NCT04123080, which also lists 4 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 10 Oct 2019.