EUS-GUIDED GALLBLADDER DRAINAGE VERSUS CONSERVATIVE MANAGEMENT IN PATIENTS UNFIT FOR SURGERY AFTER A BILIARY EVENT WITHOUT CHOLECYSTITIS. DRECON STUDY (DRECON)
12. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
110
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Emma Sudrià López
- Telefonnummer: 937 36 50 50
- E-Mail: malaltiaceliaca@mutuaterrrassa.cat
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: EUS-GBD
|
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.
|
|
Aktiver Komparator: 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).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Clinical biliary recurrence rate at 1-year follow-up
Zeitfenster: 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.
|
12 months after procedure (in experimental Arm 1- EUS-GBD) or randomization (in case of Arm 2 - CM)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
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- 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.
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- 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.
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- 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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- 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.
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juli 2026
Primärer Abschluss (Geschätzt)
1. Juli 2029
Studienabschluss (Geschätzt)
1. Juli 2029
Studienanmeldedaten
Zuerst eingereicht
12. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. Juni 2026
Zuerst gepostet (Tatsächlich)
18. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- E/26-045
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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