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Delayed bleeding is the most frequent (5 to 15%) and challenging complication after large colorectal polypectomy. Different 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. A newly developed endoscopic hemostatic powder generating gelation effect (Nexpowder) may be an effective alternative to prevent post polypectomy bleeding in patients treated by endoscopic mucosal resection (EMR) for large superficial colorectal lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated group: Nexpowder application on the scar after EMR with coagulation of visible vessels | Experimental | To compare of the risk of bleeding after EMR application of nexpower (not a drug but a device with CE mark) on the resect area (scar) to cover the whole surface of mucosal resection. |
|
| standard procedure : EMR with coagulation of visible vessels | No Intervention | After EMR with coagulation of visible vessels, if the patient is randomized in the comparative group, not nexpowder will be applied on the scar (common practice) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic mucosal resection with nexpowder | Device | At the end of the EMR procedure, the patient will be randomized. In the treated group, Nexpowder will be sprayed thanks to a catheter inserted through the operating channel of the endoscope. |
| Measure | Description | Time Frame |
|---|---|---|
| Severe post-resection bleeding rate up to Day 30 | Number of patients with a severe post-resection bleeding. It is defined as bleeding requiring a new endoscopy or surgery, OR a radiological embolization, OR blood transfusion, OR a re-hospitalization OR haematochezia with hemoglobin loss > 2 g/dl | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| The success rate of Nexpowder application | Number of patients with a satisfactory covering of the scar by the powder | Day of resection |
| Delayed perforation rate | Number of patients with a presence of air and fluid into the peritoneal cavity on the CT scanner |
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Inclusion Criteria:
More than 18 years old
Indication of EMR for a superficial nonpedunculated colorectal lesion
Higher risk of bleeding (score GSEED RE2 ≥ 7*)
*Score GSEED RE2 (Albeniz et al GIE 2020):
Proximal location (cecum to transverse included) : 3 points
Antiplatelets or anticoagulation use: 3 points
Lesion size ≥ 40 mm: 1 point
ASA III-IV or major comorbidity: 1 point
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriel RAHMI, MD | Contact | +33(0)156092000 | gabriel.rahmi@aphp.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Européen Georges Pompidou, 20 Rue Leblanc | Paris | 75015 | France |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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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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| 30 days |
| Stenosis rate | Number of patients with the impossibility to pass through the lumen with a standard colonoscope | 30 days |
| Post coagulation syndrome | Number of patients with a fever and abdominal pain without air or fluid into the peritoneal cavity on the CT scanner. | 30 days |
| Bowel obstruction rate | Number of patients with at least one symptomatic bowel obstruction. | 30 days |
| Rate of cases requiring transfusion related to post-EMR bleeding | Number of patients for whom at least one transfusion was ordered after the EMR | 30 days |
| Rate and duration of hospitalizations | Number of hospitalizations and number of days of hospitalization per stay within 30 days after EMR | 30 days |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |