EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study (DRECON)
17 de junio de 2026 actualizado por: Hospital Mutua de Terrassa
Multicenter Comparative Clinical Trial: EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study: (DRainage, Endoscopic Ultrasound, CONservative)
Cholecystectomy is considered the standard definitive treatment after an acute biliary event (biliary colic, acute pancreatitis, cholangitis, or choledocholithiasis). However, in elderly patients and/or those with significant comorbidities, surgery is often not feasible, leaving this population at high risk of biliary event recurrence (approximately 25-31% per year without treatment).
EUS-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS) is an established endoscopic technique currently recommended for acute cholecystitis in patients unfit for surgery. It creates an internal fistula between the gallbladder and the adjacent digestive tract, allowing direct endoscopic access for stone clearance (cholecystoscopy). This approach could theoretically prevent biliary event recurrence similarly to cholecystectomy.
The DRECON study (DRainaige, Endoscopic ultrasound, CONservative) is a multicenter, randomized, comparative clinical trial evaluating whether EUS-GBD with LAMS reduces biliary recurrence at 1 year compared to conservative managment (CM) in patients unfit for surgery after a biliary event without acute cholecystitis who are candidates for elective cholecystectomy.
Primary hypothesis: EUS-GBD will reduce the risk of biliary event recurrence (biliary colic, acute pancreatitis, cholangitis, choledocholithiasis, or cholecystitis) at 1 year of follow-up compared to conservative management in patients unfit for surgery with gallbladder lithiasis.
Estimated sample: 110 patients (55 per arm). Randomization 1:1 (EUS-GBD vs CM), stratified by centre and prior biliary sphincterotomy. Duration: 24 months recruitment + 12 months follow-up (total 3 years).
Participating centres: Hospital Universitari Mútua de Terrassa (coordinating centre), Hospital Universitari de Bellvitge, Hospital General de Granollers, Hospital Universitari Parc Taulí de Sabadell, Hospital Universitari de la Santa Creu i Sant Pau, Hospital Clínico Universitario de Valencia, Hospital General Universitario Dr Balmis and Complexo Hospitalario Universitario de A Coruña.
Descripción general del estudio
Estado
Estado
Aún no reclutando
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Intervencionista
Inscripción (Estimado)
Inscripción
110
Fase
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Emma Sudrià López
- Número de teléfono: 937 36 50 50
- Correo electrónico: malaltiaceliaca@mutuaterrrassa.cat
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Patients ≥ 18 years of age
- Patients who have experienced a benign biliary event (biliary colic, acute pancreatitis, cholangitis, or choledocholithiasis) and are candidates for elective cholecystectomy
- Patients deemed unfuit for surgery (age ≥ 80 years, ASA score ≥ 3, Charlson Comorbidity Index ≥ 5) or who voluntarily refuse surgery
- Diagnosis of lithogenic/lithiasic material in the gallbladder by imaging (biliary sludge, microlithiasis, and/or cholelithiasis)
- Signed informed consent
Exclusion Criteria:
- No signed informed consent
- Prior cholecystectomy
- Biliary event secondary to malignant etiology
- Acute cholecystitis diagnosed according to Tokyo 2018 criteria
- Moderate-to-severe ascites without prior paracentesis
- Perforated gallbladder
- Severe coagulopathy (INR > 1.5) or thrombocytopenia (platelets < 50,000/μL) not correctable
- Any clinical condition preventing sedation
- Patient dependent for daily activities (ECOG ≥ 4)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
2
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: EUS-GBD
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Endoscopic procedure under CO2 insufflation using a therapeutic linear echoendoscope (therapeutic channel >3.7 mm).
A cholecystogastrostomy or cholecystoduodenostomy is created by deploying a LAMS between the gallbladder and the gastric antrum or duodenal bulb (operator's choice).
A coaxial double-pigtail plastic stent (7Fr, 3-5 cm) is placed through the LAMS.
|
|
Comparador activo: CM
|
Standard supportive medical care will be determined by the treating medical team according to clinical evolution (analgesia, fluid support, antibiotic therapy, etc.).
Patients with lithogenic material in the extrahepatic bile duct confirmed by imaging or EUS will undergo endoscopic retrograde cholangiopancreatography (ERCP).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical biliary recurrence rate at 1-year follow-up
Periodo de tiempo: 12 months after procedure (in experimental Arm 1- EUS-GBD) or randomization (in case of Arm 2 - CM)
|
Percentage of patients presenting a new biliary event (biliary colic, acute pancreatitis, cholangitis, choledocholithiasis, or cholecystitis) defined according to Tokyo 2018 guidelines and revised Atlanta 2012 criteria.
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12 months after procedure (in experimental Arm 1- EUS-GBD) or randomization (in case of Arm 2 - CM)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- van Baal MC, Besselink MG, Bakker OJ, van Santvoort HC, Schaapherder AF, Nieuwenhuijs VB, Gooszen HG, van Ramshorst B, Boerma D; Dutch Pancreatitis Study Group. Timing of cholecystectomy after mild biliary pancreatitis: a systematic review. Ann Surg. 2012 May;255(5):860-6. doi: 10.1097/SLA.0b013e3182507646.
- Walter D, Teoh AY, Itoi T, Perez-Miranda M, Larghi A, Sanchez-Yague A, Siersema PD, Vleggaar FP. EUS-guided gall bladder drainage with a lumen-apposing metal stent: a prospective long-term evaluation. Gut. 2016 Jan;65(1):6-8. doi: 10.1136/gutjnl-2015-309925. Epub 2015 Jun 3. No abstract available.
- Flynn DJ, Memel Z, Hernandez-Barco Y, Visrodia KH, Casey BW, Krishnan K. Outcomes of EUS-guided transluminal gallbladder drainage in patients without cholecystitis. Endosc Ultrasound. 2021 Sep-Oct;10(5):381-386. doi: 10.4103/EUS-D-21-00040.
- Teoh AYB, Kitano M, Itoi T, Perez-Miranda M, Ogura T, Chan SM, Serna-Higuera C, Omoto S, Torres-Yuste R, Tsuichiya T, Wong KT, Leung CH, Chiu PWY, Ng EKW, Lau JYW. Endosonography-guided gallbladder drainage versus percutaneous cholecystostomy in very high-risk surgical patients with acute cholecystitis: an international randomised multicentre controlled superiority trial (DRAC 1). Gut. 2020 Jun;69(6):1085-1091. doi: 10.1136/gutjnl-2019-319996. Epub 2020 Mar 12.
- Garcia-Sumalla A, Loras C, Guarner-Argente C, Velasquez-Rodriguez JG, Andujar X, Salord S, Busquets J, Tebe C, Laquente B, Gornals JB. Is a coaxial plastic stent within a lumen-apposing metal stent useful for the management of distal malignant biliary obstruction? Surg Endosc. 2021 Aug;35(8):4873-4881. doi: 10.1007/s00464-021-08435-9. Epub 2021 Mar 15.
- Bazaga S, Garcia-Alonso FJ, Aparicio Tormo JR, Martinez Moreno B, Sanchiz V, Suria C, Garcia-Sumalla A, Gornals JB, Chavarria C, Loras C, Garcia-Fernandez FJ, Teran A, Vazquez-Sequeiros E, Pedraza Sanz R, Perez-Carazo L, Subtil JC, Perez-Millan A, Uceda Porta F, Busto Bea V, de la Serna-Higuera C, Pinto Garcia I, Colan-Hernandez J, Huertas C, Guarner-Argente C, Perez-Miranda M; RNPAL (Registro nacional de protesis de aposicion luminal [national lumen-apposing metal stent registry]) study group. Endoscopic removal of lumen-apposing metal stents - risk factors for stent embedment, complex removals, and adverse events: analysis from a multicenter prospective case series. Endoscopy. 2023 Jul;55(7):591-598. doi: 10.1055/a-2030-4158. Epub 2023 Mar 7.
- Martinez-Moreno B, Lopez-Roldan G, Escuer J, Gornals JB, Loras C, Gordo A, Vila J, Bazaga S, Dura M, Sanchiz V, Zaragoza N, Gonzalez-Huix F, Repiso A, Aparicio JR. Outcomes of a multicenter registry on EUS-guided gallbladder drainage as a rescue technique for malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography. Endosc Ultrasound. 2025 Mar-Apr;14(2):73-78. doi: 10.1097/eus.0000000000000116. Epub 2025 May 5.
- Sumalla-Garcia A, Aparicio-Tormo JR, Pedraza-Sanz R, Sanchiz-Soler V, De-la-Serna Higuera C, Andujar X, Vazquez-Sequeiros E, Puigcerver-Mas M, Martinez-Moreno B, Barbera T, Capilla-Lozano M, Martinez-Ortega A, Foruny-Olcina JR, Luna-Rodriguez D, Garcia-Lerma E, Penafiel J, Busquets Barenys J, Laquente-Saez B, Perez-Miranda M, Videla S, Loras C, Gornals JB; Spanish Working Group on Endoscopic Ultrasound Biliary Drainage. Lumen-Apposing Stents With or Without Pigtail in Endosonography-Guided Biliary Drainage for Malignant Distal Biliary Obstruction. Clin Gastroenterol Hepatol. 2026 Mar;24(3):678-687.e21. doi: 10.1016/j.cgh.2025.05.025. Epub 2025 Jul 21.
- Troncone E, Amendola R, Moscardelli A, De Cristofaro E, De Vico P, Paoluzi OA, Monteleone G, Perez-Miranda M, Del Vecchio Blanco G. Endoscopic Gallbladder Drainage: A Comprehensive Review on Indications, Techniques, and Future Perspectives. Medicina (Kaunas). 2024 Apr 14;60(4):633. doi: 10.3390/medicina60040633.
- Bazaga S, Garcia-Alonso FJ, Aparicio Tormo JR, Martinez Moreno B, Sanchiz V, Gornals JB, Loras C, Teran A, Vazquez-Sequeiros E, Pedraza Sanz R, Subtil JC, Perez-Millan A, Uceda Porta F, Vila JJ, de la Serna-Higuera C, Couto-Worner I, Guarner-Argente C, Perez-Miranda M; RNPAL (Registro nacional de protesis de aposicion luminal, national lumen-apposing metal stent registry) study group. Endoscopic ultrasound-guided gallbladder drainage with long-term lumen-apposing metal stent indwell: 1-year results from a prospective nationwide observational study. J Gastroenterol Hepatol. 2024 Feb;39(2):360-368. doi: 10.1111/jgh.16392. Epub 2023 Nov 3.
- Koutlas NJ, Pawa S, Russell G, Pawa R. Endoscopic Ultrasound-Guided Gallbladder Drainage: Beyond Cholecystitis. Diagnostics (Basel). 2023 Jun 1;13(11):1933. doi: 10.3390/diagnostics13111933.
- Robles-Medranda C, Oleas R, Puga-Tejada M, Alcivar-Vasquez J, Del Valle R, Olmos J, Arevalo-Mora M, Egas-Izquierdo M, Tabacelia D, Baquerizo-Burgos J, Pitanga-Lukashok H. Prophylactic EUS-guided gallbladder drainage prevents acute cholecystitis in patients with malignant biliary obstruction and cystic duct orifice involvement: a randomized trial (with video). Gastrointest Endosc. 2023 Mar;97(3):445-453. doi: 10.1016/j.gie.2022.10.037. Epub 2022 Nov 1.
- van Wanrooij RLJ, Bronswijk M, Kunda R, Everett SM, Lakhtakia S, Rimbas M, Hucl T, Badaoui A, Law R, Arcidiacono PG, Larghi A, Giovannini M, Khashab MA, Binmoeller KF, Barthet M, Perez-Miranda M, van Hooft JE, van der Merwe SW. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2022 Mar;54(3):310-332. doi: 10.1055/a-1738-6780. Epub 2022 Feb 3.
- Teoh AY, Perez-Miranda M, Kunda R, Lee SS, Irani S, Yeaton P, Sun S, Baron TH, Moon JH, Holt B, Khor CJL, Rerknimitr R, Bapaye A, Chan SM, Choi HJ, James TW, Kongkam P, Lee YN, Parekh P, Ridtitid W, Serna-Higuera C, Tan DMY, Torres-Yuste R. Outcomes of an international multicenter registry on EUS-guided gallbladder drainage in patients at high risk for cholecystectomy. Endosc Int Open. 2019 Aug;7(8):E964-E973. doi: 10.1055/a-0915-2098. Epub 2019 Jul 24.
- Canakis A, Tugarinov N, Deliwala S, Twery B, Miro-Gonzalez A, Beran A, Gorman EF, Hathorn K, Gilman AJ, Chawla S, Irani SS, Baron TH. Clinical outcomes of Endoscopic ultrasound--guided gallbladder drainage in patients with acute cholecystitis with >/=1 year of follow-up: a systematic review and meta-analysis. Gastrointest Endosc. 2026 Jan;103(1):48-56.e11. doi: 10.1016/j.gie.2025.07.025. Epub 2025 Jul 22.
- Martinez-Moreno B, Lopez-Roldan G, Martinez-Sempere J, de-Madaria E, Jover R, Aparicio JR. Long-term results after EUS gallbladder drainage in high-surgical-risk patients with acute cholecystitis: A 3-year follow-up registry. Endosc Int Open. 2023 Nov 10;11(11):E1063-E1068. doi: 10.1055/a-2180-9817. eCollection 2023 Nov.
- David Y, Kakked G, Confer B, Shah R, Khara H, Diehl DL, Krafft MR, Shah-Khan SM, Nasr JY, Benias P, Trindade A, Muniraj T, Aslanian H, Chahal P, Rodriguez J, Adler DG, Dubroff J, De Latour R, Tzimas D, Khanna L, Haber G, Goodman AJ, Hoerter N, Pandey N, Bakhit M, Kowalski TE, Loren D, Chiang A, Schlachterman A, Nieto J, Deshmukh A, Ichkhanian Y, Khashab MA, El Halabi M, Kwon RS, Prabhu A, Hernandez-Lara A, Storm A, Berzin TM, Poneros J, Sethi A, Gonda TA, Kushnir V, Cosgrove N, Mullady D, Al-Shahrani A, D'Souza L, Buscaglia J, Bucobo JC, Rolston V, Kedia P, Kasmin F, Nagula S, Kumta NA, DiMaio C. US multicenter outcomes of endoscopic ultrasound-guided gallbladder drainage with lumen-apposing metal stents for acute cholecystitis. Endosc Int Open. 2025 Jan 13;13:a24955542. doi: 10.1055/a-2495-5542. eCollection 2025.
- Lisotti A, Linguerri R, Bacchilega I, Cominardi A, Marocchi G, Fusaroli P. EUS-guided gallbladder drainage in high-risk surgical patients with acute cholecystitis-procedure outcomes and evaluation of mortality predictors. Surg Endosc. 2022 Jan;36(1):569-578. doi: 10.1007/s00464-021-08318-z. Epub 2021 Jan 28.
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- Hayat U, Al Shabeeb R, Perez P, Hensien J, Dwivedi A, Sakhawat U, Ahmad O, Haseeb M, Siddiqui AA, Adler DG. Safety and adverse events of EUS-guided gallbladder drainage using lumen-apposing metal stents and percutaneous cholecystostomy tubes: a systematic review and meta-analysis. Gastrointest Endosc. 2024 Mar;99(3):444-448.e1. doi: 10.1016/j.gie.2023.10.043. Epub 2023 Oct 21.
- van der Merwe SW, van Wanrooij RLJ, Bronswijk M, Everett S, Lakhtakia S, Rimbas M, Hucl T, Kunda R, Badaoui A, Law R, Arcidiacono PG, Larghi A, Giovannini M, Khashab MA, Binmoeller KF, Barthet M, Perez-Miranda M, van Hooft JE. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Feb;54(2):185-205. doi: 10.1055/a-1717-1391. Epub 2021 Dec 22.
- Lau JY, Leow CK, Fung TM, Suen BY, Yu LM, Lai PB, Lam YH, Ng EK, Lau WY, Chung SS, Sung JJ. Cholecystectomy or gallbladder in situ after endoscopic sphincterotomy and bile duct stone removal in Chinese patients. Gastroenterology. 2006 Jan;130(1):96-103. doi: 10.1053/j.gastro.2005.10.015.
- Garcia de la Filia Molina I, Garcia Garcia de Paredes A, Martinez Ortega A, Marcos Carrasco N, Rodriguez De Santiago E, Sanchez Aldehuelo R, Foruny Olcina JR, Gonzalez Martin JA, Lopez Duran S, Vazquez Sequeiros E, Albillos A. Biliary sphincterotomy reduces the risk of acute gallstone pancreatitis recurrence in non-candidates for cholecystectomy. Dig Liver Dis. 2019 Nov;51(11):1567-1573. doi: 10.1016/j.dld.2019.05.007.
- Bergman S, Al-Bader M, Sourial N, Vedel I, Hanna WC, Bilek AJ, Galatas C, Marek JE, Fraser SA. Recurrence of biliary disease following non-operative management in elderly patients. Surg Endosc. 2015 Dec;29(12):3485-90. doi: 10.1007/s00464-015-4098-9. Epub 2015 Feb 12.
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
1 de julio de 2026
Finalización primaria (Estimado)
Finalización primaria
1 de julio de 2029
Finalización del estudio (Estimado)
Finalización del estudio
1 de julio de 2029
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
12 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
18 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
22 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
17 de junio de 2026
Última verificación
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- E/26-045
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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