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The primary objective of the study is to demonstrate the superiority of an "early tips" strategy over standard treatment by glue obliteration (G0) in preventing bleeding recurrence or death at one year after a non GOV1 gastric variceal bleeding in cirrhotic patients initially treated by GO.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early TIPS | Other | Transjugular portosytemic shunt within 72h |
|
| Glue obliteration | Other | glue obliteration repeated sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transjugular Portosytemic Shunt (TIPS) | Procedure | The TIPS is placed under radiologic guidance. A branch of the intrahepatic portal vein is punctured; afterwards, the splenic vein is catheterized so that a portal venography and pressure measurements can be performed. Then, the parenchymal track is dilated and a stent is placed. A final portography and pressure measurement in the main portal vein and the inferior caval vein are performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinically significant rebleeding (upper gastrointestinal bleeding whatever its origin) | Defined by Baveno VI consens group as a recurrent melena or hematemesis resulting in any of the following:
| 12 months |
| death | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality and liver-related mortality | Day 42 | |
| All-cause mortality and liver-related mortality | 12 months | |
| Incidence of rebleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | France | ||||
| University Hospital of Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40517780 | Derived | Cervoni JP, Weil D, Desmarets M, Lannes A, D'Alteroche L, Bouzbib C, Larrue H, Lemaitre E, Faure S, Latournerie M, Jezequel C, Billioud C, Carbonell N, Saliba F, Tanne F, Hiriart JB, Olivier-Hourmand I, Nguyen Khac E, Archambeaud I, Hilleret MN, Oberti F, Elkrief L, Meunier L, Gerster T, Rode A, Bardou-Jacquet E, Robic MA, Ozenne V, Sacleux SC, Reboux N, Chermak F, Calame P, Borentain P, Thevenot T, Di Martino V, Thabut D, Louvet A, Rudler M, Bureau C; le Club Francophone pour l'Etude de l'Hypertension Portale, and the GAVAPROSEC study group. Pre-emptive TIPS for gastric variceal bleeding in patients with cirrhosis (GAVAPROSEC): an open-label randomised clinical trial. Lancet Gastroenterol Hepatol. 2025 Aug;10(8):726-733. doi: 10.1016/S2468-1253(25)00156-6. Epub 2025 Jun 12. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 8, 2024 | Mar 26, 2024 |
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|
| glue obliteration | Procedure | The standard protocol uses cyanoacrylate and lipiodol in 1:1 ratio injecting with no more than 1 mL at the varix each time. In most cases, cyanoacrylate is usually extruded into the stomach lumen within 1-3 months after injection. The French observational survey observed that a large majority (78%) of practitioners diluted glue with lipiodol and most (68%) proposed a proportion of glue to lipiodol of 1:1 the total volume injected per varix (from 1mL to 20 mL) varied substantially. Regarding the type of glue, although the majority of published data concern Histoacryl®, nearly half of practitioners used Glubran®. This lack of preference for one glue over the other may be explained by the fact that only Glubran® is approved in this indication in Europe. |
|
| Day 42 |
| Incidence of rebleeding | Day 90 |
| Incidence of rebleeding | 3 months |
| Incidence of rebleeding | 12 months |
| Cumulative number of packed red blood cells | Day 42 |
| Cumulative number of packed red blood cells | 12 months |
| Incidence of complications of cirrhosis (infections, ascites, hepatic encephalopathy, hepatorenal syndrome) during follow-up | 12 months |
| Frequency of TIPS complications | 12 months |
| Frequency of glue obliteration complications | 12 months |
| MELD score (Model for End Stage Liver Disease) in TIPS group | MELD score = 9.57*LN(creatinin in mg/dl) + 3.78*LN(Bilirubin in mg/dl) + 11.2*LN(INR) + 6.43 | 6 months |
| MELD score (Model for End Stage Liver Disease) in glue obliteration group | MELD score = 9.57*LN(creatinin in mg/dl) + 3.78*LN(Bilirubin in mg/dl) + 11.2*LN(INR) + 6.43 | 6 months |
| Number of days of hospitalization | 12 months |
| Angers |
| France |
| University Hospital of Besançon | Besançon | France |
| Univerity Hospital of Bondy | Bondy | France |
| University Hospital of Bordeaux | Bordeaux | France |
| CHRU Brest | Brest | France |
| University Hospital of Caen | Caen | France |
| University Hospital of Dijon | Dijon | France |
| University Hospital of Lille | Lille | France |
| CHU Lyon | Lyon | France |
| University Hospital of Marseille | Marseille | France |
| University Hospital of Montpellier | Montpellier | France |
| University Hospital of Nantes | Nantes | France |
| University Hospital of Nice | Nice | France |
| Pitié Salpétrière Hospital | Paris | France |
| St Antoine Hospital | Paris | France |
| University Hospital of Rennes | Rennes | France |
| University Hospital of Toulouse | Toulouse | France |
| University Hospital of Tours | Tours | France |
| Paul Brousse Hospital | Villejuif | France |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D019168 | Portasystemic Shunt, Transjugular Intrahepatic |
| ID | Term |
|---|---|
| D011170 | Portasystemic Shunt, Surgical |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
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