Polyp of Large IntestineHSPvsHSPASINCT02239536
Hot Snare Versus Hot Snare Polypectomy With Saline Injection for Colorectal Polyps
A study testing hot snare polypectomy and hot snare polypectomy after saline injection in people with Polyp of Large Intestine, run by Bo-In Lee at 1 site in South Korea.
Trial summary
The complete removal of colorectal polyp is required to prevent tumor recurrence and development of potential interval cancers. However, several studies have shown high incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5 mm. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Polyp of Large Intestine
- What is being tested?
- hot snare polypectomy and hot snare polypectomy after saline injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Feb 2018
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 30
- 5~10mm sized colorectal polyps
- Informed consent
Who cannot join
- Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)
- Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy
- ASA class III or more
- Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Gastroenterology; Seoul St. Mary's hospital
Seoul, 137-701
About this study
Official title: Hot Snare Polypectomy Vs. Hot Snare Polypectomy After Saline Injection for the Complete Resection of Neoplastic Colorectal Polyps: Prospective, Randomized Controlled Trial
The complete removal of colorectal polyp is required to prevent tumor recurrence and development of potential interval cancers. However, several studies have shown high incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5 mm. The polypectomy techniques using hot snare are usually used for the removal of these polyps. However, the optimal technique for complete resection of these polyps is unknown. There are few data comparing hot snare polypectomy with hot snare polypectomy after saline injection for complete resection of colorectal polyps (5mm or larger). The aim of this study is to compare hot snare polypectomy with hot snare polypectomy after saline injection for removal of 5-10mm sized colorectal polyps.
- Conditions
- Polyp of Large Intestine
- Being tested
- hot snare polypectomy, hot snare polypectomy after saline injection
- Keywords
- neoplastic colorectal polyp, hot snare polypectomy, hot snare polypectomy after saline injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hot snare polypectomyProcedure or surgery
hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
hot snare polypectomy after saline injectionProcedure or surgery
hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
| Study group | Role | What they receive |
|---|---|---|
| Hot snare polypectomy | Experimental | Intervention: Procedure: removal of eligible polyps using hot snare polypectomy technique Receives: Procedure: hot snare polypectomy |
| Hot snare polypectomy(saline injection) | Experimental | Intervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique Receives: Procedure: hot snare polypectomy after saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Resection Rate
Complete resection was defined as the absence of residual polyp in the resection margin
Measured: 2 weeks after
Secondary outcomes (1)
Lateral Margin
Observation of maring on a recsected specimen
Measured: 2 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2017
- Study completionFeb 2018
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 (4)Papers the sponsor has linked to this study.
- Other trials for Polyp of Large IntestineStudies 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
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bo-In Lee
- Sponsor type
- University, hospital or other
- Collaborators
- St Vincent's Hospital, Incheon St.Mary's Hospital
- Responsible party
- Sponsor-investigator, Bo-In Lee, Seoul St. Mary's Hospital
- Investigators
- Bo-In Lee, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239536
- Sponsor's protocol ID
- XC14TIMI0039K
- Acronym
- HSPvsHSPASI
- Status last verified
- Apr 2020
- First submitted
- 10 Sep 2014
- Last updated
- 14 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dwyer JP, Tan JYC, Urquhart P, Secomb R, Bunn C, Reynolds J, La Nauze R, Kemp W, Roberts S, Brown G. A prospective comparison of cold snare polypectomy using traditional or dedicated cold snares for the resection of small sessile colorectal polyps. Endosc Int Open. 2017 Nov;5(11):E1062-E1068. doi: 10.1055/s-0043-113564. Epub 2017 Oct 27.
PubMed 29250580Kim JS, Lee BI, Choi H, Jun SY, Park ES, Park JM, Lee IS, Kim BW, Kim SW, Choi MG. Cold snare polypectomy versus cold forceps polypectomy for diminutive and small colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2015 Mar;81(3):741-7. doi: 10.1016/j.gie.2014.11.048.
PubMed 25708763Kawamura T, Takeuchi Y, Asai S, Yokota I, Akamine E, Kato M, Akamatsu T, Tada K, Komeda Y, Iwatate M, Kawakami K, Nishikawa M, Watanabe D, Yamauchi A, Fukata N, Shimatani M, Ooi M, Fujita K, Sano Y, Kashida H, Hirose S, Iwagami H, Uedo N, Teramukai S, Tanaka K. A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study). Gut. 2018 Nov;67(11):1950-1957. doi: 10.1136/gutjnl-2017-314215. Epub 2017 Sep 28.
PubMed 28970290Kim SJ, Lee BI, Jung ES, Kim JS, Jun SY, Kim W, Ham H, Kim M, Lee SH, Lee HH, Park JM, Choi MG. Hot snare polypectomy versus endoscopic mucosal resection for small colorectal polyps: a randomized controlled trial. Surg Endosc. 2021 Sep;35(9):5096-5103. doi: 10.1007/s00464-020-07994-7. Epub 2020 Sep 28.
PubMed 32989532
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hot Snare Polypectomy Vs. Hot Snare Polypectomy After Saline Injection for the Complete Resection of Neoplastic Colorectal Polyps: Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02239536
- Acronym / sponsor ID
- HSPvsHSPASI / XC14TIMI0039K
- Conditions
- Polyp of Large Intestine
- Keywords
- neoplastic colorectal polyp, hot snare polypectomy, hot snare polypectomy after saline injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Bo-In LeeUniversity, hospital or other
- Collaborators
- St Vincent's Hospital, Incheon St.Mary's Hospital
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 12 Sep 2014 (estimated)
- Results
- Posted 14 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The complete removal of colorectal polyp is required to prevent tumor recurrence and development of potential interval cancers. However, several studies have shown high incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5 mm. The polypectomy techniques using hot snare are usually used for the removal of these polyps. However, the optimal technique for complete resection of these polyps is unknown. There are few data comparing hot snare polypectomy with hot snare polypectomy after saline injection for complete resection of colorectal polyps (5mm or larger). The aim of this study is to compare hot snare polypectomy with hot snare polypectomy after saline injection for removal of 5-10mm sized colorectal polyps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hot snare polypectomy | Experimental | Procedure: hot snare polypectomyIntervention: Procedure: removal of eligible polyps using hot snare polypectomy technique |
| Hot snare polypectomy(saline injection) | Experimental | Procedure: hot snare polypectomy after saline injectionIntervention: Procedure: removal of eligible polyps using hot snare polypectomy after saline injection technique |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over the age of 30
- 5~10mm sized colorectal polyps
- Informed consent
Key exclusion criteria (4 listed)
- Inflammatory bowel diseases (Crohn's disease, or ulcerative colitis)
- Patient undergoing antiplatelets (aspirin, clopidogrel and others) or anticoagulant therapy
- ASA class III or more
- Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if he/she were to participate in the study
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 |
|---|---|---|
| hot snare polypectomyhot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps | Procedure or surgery | Hot snare polypectomy |
| hot snare polypectomy after saline injectionhot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps | Procedure or surgery | Hot snare polypectomy(saline injection) |
Primary outcome
Complete Resection Rate
Time frame: 2 weeks after
Complete resection was defined as the absence of residual polyp in the resection margin
1 secondary outcome
Lateral Margin
Time frame: 2 weeks after
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29250580Dwyer JP, Tan JYC, Urquhart P, Secomb R, Bunn C, Reynolds J, La Nauze R, Kemp W, Roberts S, Brown G. A prospective comparison of cold snare polypectomy using traditional or dedicated cold snares for the resection of small sessile colorectal polyps. Endosc Int Open. 2017 Nov;5(11):E1062-E1068. doi: 10.1055/s-0043-113564. Epub 2017 Oct 27.
- Background: PubMed 25708763Kim JS, Lee BI, Choi H, Jun SY, Park ES, Park JM, Lee IS, Kim BW, Kim SW, Choi MG. Cold snare polypectomy versus cold forceps polypectomy for diminutive and small colorectal polyps: a randomized controlled trial. Gastrointest Endosc. 2015 Mar;81(3):741-7. doi: 10.1016/j.gie.2014.11.048.
- Background: PubMed 28970290Kawamura T, Takeuchi Y, Asai S, Yokota I, Akamine E, Kato M, Akamatsu T, Tada K, Komeda Y, Iwatate M, Kawakami K, Nishikawa M, Watanabe D, Yamauchi A, Fukata N, Shimatani M, Ooi M, Fujita K, Sano Y, Kashida H, Hirose S, Iwagami H, Uedo N, Teramukai S, Tanaka K. A comparison of the resection rate for cold and hot snare polypectomy for 4-9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study). Gut. 2018 Nov;67(11):1950-1957. doi: 10.1136/gutjnl-2017-314215. Epub 2017 Sep 28.
- Derived from this study: PubMed 32989532Kim SJ, Lee BI, Jung ES, Kim JS, Jun SY, Kim W, Ham H, Kim M, Lee SH, Lee HH, Park JM, Choi MG. Hot snare polypectomy versus endoscopic mucosal resection for small colorectal polyps: a randomized controlled trial. Surg Endosc. 2021 Sep;35(9):5096-5103. doi: 10.1007/s00464-020-07994-7. Epub 2020 Sep 28.
- 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.
Bo-In Lee principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hot snare polypectomy and hot snare polypectomy after saline injection in people with Polyp of Large Intestine, run by Bo-In Lee at 1 site in South Korea.
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 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 14 Apr 2020. 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 South Korea. 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 14 Apr 2020). 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?
Complete Resection Rate (time frame: 2 weeks after). 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 NCT02239536, 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 14 Apr 2020.