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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004230-20 | EudraCT Number |
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Most patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from underlying liver disease and are exposed to the risk of postoperative ascites, with subsequent morbidity, liver and renal failure, the need for specific treatments and prolonged hospital stay. Postoperative ascites is favored by an imbalance between portal venous inflow and the diminished hepatic venous outflow. Finding a reversible, non-invasive method for modulating the portal inflow would be of interest: it could be used temporarily during the early postoperative course to prevent acute portal hypertension. Somatostatin, a well-known drug already used in several indications, may limit the risk of postoperative ascites and liver failure by decreasing portal pressure after hepatectomy for HCC in patients with underlying liver disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day |
|
| Control group | Placebo Comparator | Placebo infusion (50ml of 0.9% NaCl/day) during 6 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatostatin infusion | Drug | postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| presence of postoperative ascites during the postoperative course | The presence of postoperative ascites during the postoperative course defined by:
| Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of ascites | Number of days with ≥ 500ml / 24h of ascites | Day 90 |
| Volume of ascites | Total ascites volume | Day 90 |
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Inclusion Criteria:
Exclusion Criteria:
Disease-associated non-inclusion criteria include:
Operative technique-associated non-inclusion criteria include:
- Indication of coelioscopy with resection of less than 2 liver segments
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHP - Hôpital Beaujon | Clichy | France | ||||
| CHRU Lille - Hopital Huriez |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30139340 | Background | Mohkam K, Rayar M, Adam JP, Muscari F, Rode A, Merle P, Pradat P, Bauler S, Delfour I, Chiche L, Ducerf C, Boudjema K, Lesurtel M, Laurent C, Mabrut JY. Evaluation of postoperative ascites after somatostatin infusion following hepatectomy for hepatocellular carcinoma by laparotomy: a multicenter randomized double-blind controlled trial (SOMAPROTECT). BMC Cancer. 2018 Aug 23;18(1):844. doi: 10.1186/s12885-018-4667-0. |
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| placebo infusion | Drug | Placebo infusion (50ml of 0.9% NaCl/day) during 6 days. |
|
| postoperative morbidity | Postoperative morbidity according to Dindo-Clavien | Day 90 |
| Postoperative morbidity on Liver failure | Presence and severity of hepatic failure according to International Study Group of Liver Surgery (ISGLS) | Day 90 |
| Postoperative morbidity on Renal failure | Presence and severity of renal failure according to RIFLE scale (RIFLE: Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) | Day 90 |
| Lille |
| France |
| Hospices Civils de Lyon - Hôpital de la Croix Rousse | Lyon | 69004 | France |
| APHM - Hôpital de la Timone | Marseille | France |
| CHU de Bordeaux - Hôpital Haut Lévèque | Pessac | France |
| CHU Rennes - Hôpital Pontchaillou | Rennes | France |
| CHU de Toulouse - Hopital Rangueil | Toulouse | France |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D001201 | Ascites |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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