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The problem of delayed bleeding after endoscopic resection is becoming important due to the growing number of indications for anti-aggregation or anticoagulant treatment for cardiovascular reasons in the aging populations. Previous studies have shown that in patients at high risk of bleeding, the use of (PuraStat®), a simple and easily applicable solution, decreases the rate of delayed bleeding by promoting wound healing. Various preventive treatments, such as the prophylactic use of clips, have been tried to prevent the occurrence of delayed bleeding, but to date, no treatment has clearly shown its effectiveness. In addition, preventive hemostasis with clips is difficult and costly. The main objective is to compare the efficacy of PuraStat® to the standard treatment in reducing delayed bleeding after colorectal ESD in patients at high risk of delayed bleeding. The secondary objectives are to compare the same two strategies in terms of effectiveness and side effects. The primary outcome measure is the percentage of delayed bleeding at 30 days after surgery (ESD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic submucosal dissection with Purastat | Experimental | To compare of the risk of bleeding after endoscopic submucosal dissection, after ESD, application of Purastat gel (not a drug but a device with CE mark) with a catheter of a gel on the resected area to cover the whole surface of mucosal resection. |
|
| Comparative arm without Purastat | No Intervention | After endoscopic submucosal dissection (ESD) and hemostasis, if the patient is randomized in the comparative group, no gel will be applied on the resected area that will remain like this without intervention (common practice) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic submucosal dissection with Purastat | Device | Purastat (peptidic gel) application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of delayed bleeding after surgery (ESD) | Percentage of delayed bleeding is expressed primarily by the number of patients with at least one unplanned colorectal endoscopy occurring within 30 days of surgery (ESD) | through study completion, an average of 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of emergency endoscopy use by risk factors for secondary bleeding | Number of patients with at least one unplanned colorectal endoscopy by factors for secondary bleeding occurring within 30 days of ESD. | through study completion, an average of 2 year |
| Rate of emergency endoscopic hemostasis use by risk factors for secondary bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathieu PIOCHE, Pr | Contact | + 33 4 72 11 03 43 | mathieu.pioche@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Edouard Herriot | Recruiting | Lyon | France |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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Number of patients requiring hemostasis, unplanned occurring within 30 days of ESD. |
| through study completion, an average of 2 year |
| Rate of cases requiring transfusion related to post-ESD bleeding | Number of patients for whom at least one transfusion was ordered after the ESD | through study completion, an average of 2 year |
| Rate of adverse events related to procedures (delayed perforation and stenosis) in each of the 2 arms | Number of patients with at least one delayed perforation or one symptomatic stenosis. | through study completion, an average of 2 year |
| Rate and duration of hospitalizations | Number of hospitalizations and number of days of hospitalization per stay within 30 days after ESD | through study completion, an average of 2 year |
| Tolerance of PuraStat | Number of patients with at least one irritation or thromboembolic accidents. | through study completion, an average of 2 year |
| Evaluation of the gel application time on the resection area | Time between introduction and removal of the PuraStat® catheter. | During the intervention |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |