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出境医 / 临床实验 / Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial (RESECT COLON)
Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial (RESECT COLON)
Study Description
Brief Summary:
Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2% However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR.
Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures.
We therefore propose to compare these two endoscopic resection strategies in terms of recurrence rate at 6 months and to estimate the differential cost-effectiveness and cost-utility ratios over a 36-month time horizon.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Colonic Polyp | Procedure: Experimental procedure : ESD Procedure: Comparison procedure: WF-piece meal EMR | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 360 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial |
| Actual Study Start Date : | September 11, 2019 |
| Estimated Primary Completion Date : | March 11, 2022 |
| Estimated Study Completion Date : | October 11, 2024 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
| Experimental: Endoscopic submucosal dissection (ESD) |
Procedure: Experimental procedure : ESD
ESD is a new endoscopic resection procedure that allows en-bloc resection for large superficial colorectal neoplasms. It used dedicated devices and consists in a deep submucosal dissection under the lesion after surelevation thanks to submucosal fluid injection and mucosal incision all around the lesion. The en bloc resection allows a perfect pathological analysis and a very low risk of recurrence (<1.5%)
|
| Active Comparator: Endoscopic Mucosal Resection (WF-piece meal EMR) |
Procedure: Comparison procedure: WF-piece meal EMR
WF-piece meal EMR is an older endoscopic resection technique. After surelevation of the lesion thanks to fluid submucosal injection, the precancerous lesion is resected in several pieces using a polypectomy snare. At the end of the procedure when macroscopically visible adenoma has been totally resected a snare tip coagulation of the margin of the scar is performed to destroy potential non visible residual adenoma. This procedure is quicker, safer than ESD but result in more recurrent disease (from 10 to 30% for lesions larger than 25 mm).
|
Outcome Measures
Primary Outcome Measures :
- Compare recurrence rate at follow-up colonoscopy [ Time Frame: Month 6 ]Compare between two groups
Secondary Outcome Measures :
- Proportion of R0 resection rate [ Time Frame: Month 1 ]Compare between two groups
- Cumulative complications rate after treatment [ Time Frame: Month 1 ]Compare between two groups
- Endoscopic curative resection rate without surgery [ Time Frame: Month 36 ]Compare between two groups
- Quality of life over time [ Time Frame: Month 36 ]Compare between two groups at Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36
- Cost-effectiveness ratio [ Time Frame: Month 36 ]Compare between two groups
- Cost-utility ratio [ Time Frame: Month 36 ]Compare between two groups
- Cumulative surgical referral rate [ Time Frame: Month 36 ]Compare between two groups
- Compare the proportion of technical failure [ Time Frame: Day 1 ]Compare between two groups
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient suffering from non-pedunculated polyp suspected larger than 25 mm in the colon
- Colon localization beyond 15 cm of the anal margin.
- Indication for endoscopic treatment
- Patients aged ≥ 18 years old
- Patients able to fill in questionnaires written in French
Exclusion Criteria:
- Prior endoscopic resection attempt
- Contra-indication to colonoscopy
- Contra-indication to general anesthesia
- Inability to stop antiplatelet agents and anti-coagulant according to the European Society of Gastro-Intestinal Endoscopy guidelines.
- Recurrent adenoma: post-endoscopic or surgical resection
- Pregnant or lactating women
- Genetic polyposis (Familial Adenomatous Polyposis, Lynch Syndrome, Peutz-Jeghers Syndrome)
- Inability to provide informed consent
- Patient under legal protection and or deprived of liberty by judicial or administrative decision
- Patient already participating in an interventional clinical research protocol
- Patient who cannot be followed for the duration of the study
- Non-pedunculated polyp ≤ 25 mm
- More than one lesion > 25 mm that fulfilled the inclusion criteria
- Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris 0-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)
- Non granular pseudodepressed Laterally spreading tumors due to the high risk of nonvisible submucosal cancer
- Polyp involving the appendice deeply (type 2 or 3 of classification of Toyonaga)
- Polyp inside the ileo-caecal valvula
- Tattoing under the lesionInflammatory Bowel Disease with expected fibrosis (Crohn disease or ulcerative colitis)
- Colon localization < 15 cm of the anal margin.
- Polyp invading a diverticulum
Contacts and Locations
Contacts
| Contact: JEREMIE JACQUES, Dr | + 33 (0) 5 55 05 88 72 | jeremie.jacques@chu-limoges.fr |
Locations
| Belgium | |
| University Clinics Saint-Luc | Not yet recruiting |
| Bruxelles, Belgium, 1200 | |
| Contact: Hubert Piessevaux | |
| France | |
| University Hospital, Limoges | Recruiting |
| Limoges, France, 87042 | |
| Contact: Jeremie JACQUES + 33 (0) 5 55 05 88 72 jeremie.jacques@chu-limoges.fr | |
| Jean Mermoz Hospital | Recruiting |
| Lyon, France, 69008 | |
| Contact: Vincent Lepilliez lepilliezvincent@orange.fr | |
| Edouard Herriot Hospital | Recruiting |
| Lyon, France, 69437 | |
| Contact: Mathieu Pioche mathieu.pioche@chu-lyon.fr | |
| Nancy University Hospital | Recruiting |
| Nancy, France, 54500 | |
| Contact: Jean-Baptiste Chevaux jb.chevaux@chru-nancy.fr | |
| Cochin Hospital | Recruiting |
| Paris, France, 75014 | |
| Contact: Stanislas Chaussade stanislas.chaussade@aphp.fr | |
| Pontchaillou Hospital | Recruiting |
| Rennes, France, 35033 | |
| Contact: Timothée Wallenhorst timothee.wallenhorst@chu-rennes.fr | |
Sponsors and Collaborators
University Hospital, Limoges
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 22, 2019 | ||||
| First Posted Date ICMJE | May 24, 2019 | ||||
| Last Update Posted Date | December 3, 2020 | ||||
| Actual Study Start Date ICMJE | September 11, 2019 | ||||
| Estimated Primary Completion Date | March 11, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Compare recurrence rate at follow-up colonoscopy [ Time Frame: Month 6 ] Compare between two groups
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial | ||||
| Official Title ICMJE | Endoscopic Submucosal Dissection (ESD) Versus Endoscopic Mucosal Resection (EMR) for Large Non Pedunculated Colonic Adenomas: a Randomized Comparative Trial | ||||
| Brief Summary |
Initially developed in Japan for the treatment of endemic superficial gastric cancers, endoscopic submucosal dissection (ESD) allows resection of pre-neoplastic and neoplastic lesions of the digestive tract into a single fragment. It allows a perfect pathological analysis, and decreases the rate of recurrence of the adenoma to less than 2% However, this procedure, which is technically more challenging, is also more risky (perforation rate at 4% vs. 1% for WF-EMR) and longer. Submucosal dissection is also more expensive in terms of equipment, but this difference can be offset by the cost of the high number of iterative colonoscopies required in patients who have had endoscopic resection by WF-EMR. Scientific debate is agitating the Western world1,2 and Japanese experts do not perform WF-EMR anymore, whereas no comparative prospective study has compared these two procedures. We therefore propose to compare these two endoscopic resection strategies in terms of recurrence rate at 6 months and to estimate the differential cost-effectiveness and cost-utility ratios over a 36-month time horizon. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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| Condition ICMJE | Colonic Polyp | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
360 | ||||
| Original Estimated Enrollment ICMJE |
330 | ||||
| Estimated Study Completion Date ICMJE | October 11, 2024 | ||||
| Estimated Primary Completion Date | March 11, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Belgium, France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03962868 | ||||
| Other Study ID Numbers ICMJE | 87RI18_0002 (RESECT COLON) | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University Hospital, Limoges | ||||
| Study Sponsor ICMJE | University Hospital, Limoges | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | University Hospital, Limoges | ||||
| Verification Date | December 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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