Colorectal PolypESDNCT03180788
The Impact of Traction Assisted ESD on Procedural Time and Outcome
A study testing Traction assisted ESD and Traditional ESD in people with Colorectal Polyp, run by Region Skane at 1 site in Sweden.
Trial summary
The aim of this study is to evaluate the role of traction assisted ESD in comparison to traditional ESD on procedural time and outcome in patients with large, non pedunculated colorectal polyps. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Polyp
- What is being tested?
- Traction assisted ESD and Traditional ESD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 8 Jan 2018to 30 Dec 2018
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 2cm, flat or sessile colorectal polyp
Who cannot join
- Recurrencies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Traction Assisted ESD on Procedural Time, En Bloc Resection, Curative Resection and Complication Incidence
The aim of this study is to evaluate the role of traction assisted ESD in comparison to traditional ESD on procedural time and outcome in patients with large, non pedunculated colorectal polyps.
Read the detailed description
Endoscopic polypectomy, has been proven to reduce Colorectal cancer incidence and mortality. Smaller lesions and pedunculated lesions can be removed by conventional polypectomy, Endoscopic mucosa resection (EMR). However, large sessile and flat lesions are difficult to remove En bloc with EMR, resulting in a high level of tumor recurrence. Endoscopic submucosal dissection (ESD) was developed during the 1990s in Japan to achieve En bloc resection of large neoplasms in the stomach but has in recent years also been extended into management of large (>2 cm) and technically challenging colorectal polyps. Large series on the efficacy of ESD in removing benign lesions show high En bloc resection rates resulting in low numbers of recurrences. Traction assisted ESD was developed in Japan to further improve the technique and reduce procedural time, the literature on the efficacy of traction assisted ESD is however scarce and limited to Japanese studies.
The aim in this study is to investigate the impact of this novel technique in comparison to traditional ESD on procedural time, En bloc resection rate, R0 resection rate and complication incidence.
- Conditions
- Colorectal Polyp
- Being tested
- Traction assisted ESD, Traditional ESD
- Keywords
- ESD, Traction assisted ESD, Polypectomy, Clip and thread ESD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traction assisted ESDProcedure or surgery
A clip attached to a thread is mounted on the lesion. Traction is achieved by pulling the thread during ESD
Traditional ESDProcedure or surgery
Endoscopic submucosa dissection
| Study group | Role | What they receive |
|---|---|---|
| Traditional ESD | Active comparator | The patients in this Group will undergo traditional ESD. Receives: Procedure: Traditional ESD |
| Traction assisted ESD | Experimental | The patients in this Group will undergo traction assisted ESD Receives: Procedure: Traction assisted ESD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural time
Time consumption to complete the resection is measured.
Measured: 280 min, procedural time
Secondary outcomes (3)
En bloc resection
En bloc resection rates will be recorded
Measured: 280 min, procedural time
R0 resection
R0 resection rate, stated in the pathology report will be recorded
Measured: 4-8 weeks, when pathological examination is completed
Complication incidence
All complications both immediate and delayed will be recorded
Measured: 2 weeks, when the timeframe for delayed complications is over.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start8 Jan 2018 (estimated)
- Primary completion20 Dec 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Why it stopped: The study was never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomiced Clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180788
- Sponsor's protocol ID
- CLIPTHREAD
- Acronym
- ESD
- Status last verified
- Feb 2021
- First submitted
- 30 May 2017
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saito Y, Uraoka T, Yamaguchi Y, Hotta K, Sakamoto N, Ikematsu H, Fukuzawa M, Kobayashi N, Nasu J, Michida T, Yoshida S, Ikehara H, Otake Y, Nakajima T, Matsuda T, Saito D. A prospective, multicenter study of 1111 colorectal endoscopic submucosal dissections (with video). Gastrointest Endosc. 2010 Dec;72(6):1217-25. doi: 10.1016/j.gie.2010.08.004. Epub 2010 Oct 27.
PubMed 21030017Ritsuno H, Sakamoto N, Osada T, Goto SP, Murakami T, Ueyama H, Mori H, Matsumoto K, Beppu K, Shibuya T, Nagahara A, Ogihara T, Watanabe S. Prospective clinical trial of traction device-assisted endoscopic submucosal dissection of large superficial colorectal tumors using the S-O clip. Surg Endosc. 2014 Nov;28(11):3143-9. doi: 10.1007/s00464-014-3572-0. Epub 2014 May 31.
PubMed 24879138
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Traction Assisted ESD on Procedural Time, En Bloc Resection, Curative Resection and Complication Incidence
- ClinicalTrials.gov ID
- NCT03180788
- Acronym / sponsor ID
- ESD / CLIPTHREAD
- Conditions
- Colorectal Polyp
- Keywords
- ESD, Traction assisted ESD, Polypectomy, Clip and thread ESD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 8 Jan 2018 (estimated)
- Primary completion
- 20 Dec 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 8 Jun 2017 (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 aim of this study is to evaluate the role of traction assisted ESD in comparison to traditional ESD on procedural time and outcome in patients with large, non pedunculated colorectal polyps.
Detailed description
Endoscopic polypectomy, has been proven to reduce Colorectal cancer incidence and mortality. Smaller lesions and pedunculated lesions can be removed by conventional polypectomy, Endoscopic mucosa resection (EMR). However, large sessile and flat lesions are difficult to remove En bloc with EMR, resulting in a high level of tumor recurrence. Endoscopic submucosal dissection (ESD) was developed during the 1990s in Japan to achieve En bloc resection of large neoplasms in the stomach but has in recent years also been extended into management of large (>2 cm) and technically challenging colorectal polyps. Large series on the efficacy of ESD in removing benign lesions show high En bloc resection rates resulting in low numbers of recurrences. Traction assisted ESD was developed in Japan to further improve the technique and reduce procedural time, the literature on the efficacy of traction assisted ESD is however scarce and limited to Japanese studies.
The aim in this study is to investigate the impact of this novel technique in comparison to traditional ESD on procedural time, En bloc resection rate, R0 resection rate and complication incidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective randomiced Clinical trial
| Arm | Type | Receives |
|---|---|---|
| Traditional ESD | Active comparator | Procedure: Traditional ESDThe patients in this Group will undergo traditional ESD. |
| Traction assisted ESD | Experimental | Procedure: Traction assisted ESDThe patients in this Group will undergo traction assisted ESD |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- > 2cm, flat or sessile colorectal polyp
Key exclusion criteria (1 listed)
- Recurrencies.
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 |
|---|---|---|
| Traction assisted ESDA clip attached to a thread is mounted on the lesion. Traction is achieved by pulling the thread during ESD | Procedure or surgery | Traction assisted ESD |
| Traditional ESDEndoscopic submucosa dissection | Procedure or surgery | Traditional ESD |
Primary outcome
Procedural time
Time frame: 280 min, procedural time
Time consumption to complete the resection is measured.
3 secondary outcomes
En bloc resection
Time frame: 280 min, procedural time
R0 resection
Time frame: 4-8 weeks, when pathological examination is completed
Complication incidence
Time frame: 2 weeks, when the timeframe for delayed complications is over.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Background: PubMed 21030017Saito Y, Uraoka T, Yamaguchi Y, Hotta K, Sakamoto N, Ikematsu H, Fukuzawa M, Kobayashi N, Nasu J, Michida T, Yoshida S, Ikehara H, Otake Y, Nakajima T, Matsuda T, Saito D. A prospective, multicenter study of 1111 colorectal endoscopic submucosal dissections (with video). Gastrointest Endosc. 2010 Dec;72(6):1217-25. doi: 10.1016/j.gie.2010.08.004. Epub 2010 Oct 27.
- Results publication: PubMed 24879138Ritsuno H, Sakamoto N, Osada T, Goto SP, Murakami T, Ueyama H, Mori H, Matsumoto K, Beppu K, Shibuya T, Nagahara A, Ogihara T, Watanabe S. Prospective clinical trial of traction device-assisted endoscopic submucosal dissection of large superficial colorectal tumors using the S-O clip. Surg Endosc. 2014 Nov;28(11):3143-9. doi: 10.1007/s00464-014-3572-0. Epub 2014 May 31.
- 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.
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 Traction assisted ESD and Traditional ESD in people with Colorectal Polyp, run by Region Skane at 1 site in Sweden.
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 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: withdrawn, as of the sponsor's last update on 15 Feb 2021. 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 Sweden. 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 was withdrawn before enrolling participants, so there are no results.
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?
Procedural time (time frame: 280 min, procedural time). 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 NCT03180788, 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 15 Feb 2021.