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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic submucosal dissection (ESD) | Experimental |
| |
| Endoscopic Mucosal Resection (WF-piece meal EMR) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental procedure : ESD | Procedure | 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%) |
| Measure | Description | Time Frame |
|---|---|---|
| Compare recurrence rate at follow-up colonoscopy | Compare between two groups | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of R0 resection rate | Compare between two groups | Month 1 |
| Cumulative complications rate after treatment | Compare between two groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Limoges | Limoges | France | 87042 | France | ||
| Jean Mermoz Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38079634 | Derived | Jacques J, Schaefer M, Wallenhorst T, Rosch T, Lepilliez V, Chaussade S, Rivory J, Legros R, Chevaux JB, Leblanc S, Rostain F, Barret M, Albouys J, Belle A, Labrunie A, Preux PM, Lepetit H, Dahan M, Ponchon T, Crepin S, Marais L, Magne J, Pioche M. Endoscopic En Bloc Versus Piecemeal Resection of Large Nonpedunculated Colonic Adenomas : A Randomized Comparative Trial. Ann Intern Med. 2024 Jan;177(1):29-38. doi: 10.7326/M23-1812. Epub 2023 Dec 12. |
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|
| Comparison procedure: WF-piece meal EMR | Procedure | 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). |
|
| Month 1 |
| Endoscopic curative resection rate without surgery | Compare between two groups | Month 36 |
| Quality of life over time | Compare between two groups at Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 | Month 36 |
| Cost-effectiveness ratio | Compare between two groups | Month 36 |
| Cost-utility ratio | Compare between two groups | Month 36 |
| Cumulative surgical referral rate | Compare between two groups | Month 36 |
| Compare the proportion of technical failure | Compare between two groups | Day 1 |
| Lyon |
| France |
| 69008 |
| France |
| Edouard Herriot Hospital | Lyon | 69437 | France |
| Nancy University Hospital | Nancy | 54500 | France |
| Cochin Hospital | Paris | 75014 | France |
| Pontchaillou Hospital | Rennes | 35033 | France |
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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