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| Name | Class |
|---|---|
| Carlos III Health Institute | OTHER_GOV |
| Spanish Clinical Research Network - SCReN | NETWORK |
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Randomized multicenter study comparing plastic stents and self-expanding metallic stents in the eus-guided transmural drainage of walled-off pancreatic necrosis.
Spanish centers partners of the spanish society of digestive endoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLASTIC STENT | Experimental | Endoscopic double pigtail plastic stent, with formal indication on pancreatic collection, according to the instruction forms of the manufacturer. Interventions associated: EUS-guided transmural drainage of pancretic collection: PLASTIC STENT. |
|
| SELF EXPANDABLE METALLIC STENT | Active Comparator | Lumen apposing metal stent with formal indicaction on pancreatic collection, according to the manufacturer instruction forms. Interventions associated: EUS-guided transmural drainage of pancretic collection: METALLIC STENT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WOPN TRANSMURAL DRAINAGE: PLASTIC STENT | Device | Endoscopic ultrasound-guided transmural drainage of walled-off pancreatic necrosis: The pancreatic collection will be located with the linear echoendoscope, and we will proceed to choose an optimal area to perform the puncture guided by EUS; with the absence of intervening vessels. This collection will be punctured with a 19 G needle or with an electrocautery device directly. Guidance will be advanced through the needle and the ostomy will proceed according to the routine of the experienced endoscopist. Placement of a plastic double pigtail, 5-10 cm in length, diameters 7-8,5-10 Fr. Minimum one 10 Fr prosthesis. Arm associated: PLASTIC STENT |
| Measure | Description | Time Frame |
|---|---|---|
| RADIOLOGICAL SUCCESS | Radiological success at 4 weeks after the interventional procedure: reduction size of the wopn at least 50%. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CLINICAL SUCCESS | Evaluate the long-term clinical success (4 months) (metallic vs. plastic) determined by the total resolution or <3cm of the WOPN, releated with clinical improvement. | 4 month |
| TECHNICAL ASPECTS |
| Measure | Description | Time Frame |
|---|---|---|
| TECHNICAL ASPECTS | Technical success: Correct release of the prosthesis (plastic or metallic) and drainage of the WOPN. | 1st day |
| TECHNICAL ASPECTS | Duration of the procedure: Minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JOAN B GORNALS, MD, PhD | Hospital Universitari de Bellvitge | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Arnau de Vilanova | Lleida | Barcelona | 25198 | Spain | ||
| Hospital Universitario Marqués de Valdecilla |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38448625 | Derived | Gornals JB, Velasquez-Rodriguez JG, Bas-Cutrina F, Garcia Garcia De Paredes A, Esteban JM, Teran A, Gonzalez-Huix F, Perez-Miranda M, Guarner-Argente C, Vila JJ, Garcia-Sumalla A, Foruny JR, Fisac-Vazquez J, Moris M, Miquel-Salas I, De-la-Serna Higuera C, Murzi-Pulgar M, Sanchez-Yague A, Salord S, Ruiz-Osuna S, Busquets J, Sanllorente-Melenchon M, Videla S, Moreno R, Tebe-Cordomi C, Hereu P, Vazquez-Sequeiros E; Spanish Working Group on Pancreatic Collection Therapy. Plastic pigtail vs lumen-apposing metal stents for drainage of walled-off necrosis (PROMETHEUS study): an open-label, multicenter randomized trial. Surg Endosc. 2024 Apr;38(4):2148-2159. doi: 10.1007/s00464-024-10699-w. Epub 2024 Mar 6. | |
| 31888751 |
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|
| WOPN TRANSMURAL DRAINAGE: METALLIC STENT | Device | Endoscopic ultrasound-guided transmural drainage of walled-off pancreatic necrosis: The pancreatic collection will be located with the linear echoendoscope, and we will proceed to choose an optimal area to perform the puncture guided by EUS; with the absence of intervening vessels. This collection will be punctured with a 19 G needle or with an electrocautery device directly. Guidance will be advanced through the needle and the ostomy will proceed according to the routine of the experienced endoscopist. Placement of a metal self-expanding fully covered luminal apposition stent: 10, 15 or 20 mm diameter. Arm associated: SELF EXPANDABLE METALLIC STENT |
|
Evaluate the technical success, duration of the procedure and level of difficulty.
| 1st day |
| INCIDENCE OF TREATMENT-EMERGENT ADVERSE EVENTS [SAFETY AND TOLERABILITY] | Assess safety: complications (immediate, early and late) | 1st day, 24h, 7 days, 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month |
| RECURRENCES | Evaluate recurrences | 4 weeks, 8 weeks, 4 month, 6 month, 8 month, 12 month |
| COSTS ANALYSIS | Evaluate the costs between the two types of strategy | 12 month |
| 1st day |
| TECHNICAL ASPECTS | Level of difficulty: Easy, Medium, Hard, Very hard | 1st day |
| Santander |
| Cantabria |
| 39008 |
| Spain |
| Hospital Costa del Sol | Marbella | Málaga | 29603 | Spain |
| Hospital San Juan de Dios | Pamplona | Navarre | 31006 | Spain |
| Hospital Universitario Río Hortega | Valladolid | Valldolid | 47012 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Derived |
| Gornals JB, Perez-Miranda M, Vazquez-Sequeiros E, Vila J, Esteban JM, Gonzalez-Huix F, Guarner-Argente C, Sanchez-Yague A, Teran A, Bas-Cutrina F, De La Serna C, De Paredes AG, Ballester R, Velasquez-Rodriguez J, Salord S, Tebe C, Hereu P, Videla S; Spanish Working Group on Pancreatic Collection Therapy. Multicenter study of plastic vs. self-expanding metal stents in endoscopic ultrasound-guided drainage of walled-off pancreatic necrosis - PROMETHEUS: a randomized controlled trial protocol. Trials. 2019 Dec 30;20(1):791. doi: 10.1186/s13063-019-3988-x. |
| ID | Term |
|---|---|
| D019283 | Pancreatitis, Acute Necrotizing |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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