EUS-GUIDED GALLBLADDER DRAINAGE VERSUS CONSERVATIVE MANAGEMENT IN PATIENTS UNFIT FOR SURGERY AFTER A BILIARY EVENT WITHOUT CHOLECYSTITIS. DRECON STUDY (DRECON)
12. června 2026 aktualizováno: 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.
Přehled studie
Postavení
Zatím nenabíráme
Podmínky
Typ studie
Intervenční
Zápis (Odhadovaný)
110
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Emma Sudrià López
- Telefonní číslo: 937 36 50 50
- E-mail: malaltiaceliaca@mutuaterrrassa.cat
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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Aktivní komparátor: CM
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Clinical biliary recurrence rate at 1-year follow-up
Časové okno: 12 months after procedure (in experimental Arm 1- EUS-GBD) or randomization (in case of Arm 2 - CM)
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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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
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- 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.
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- 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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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. července 2026
Primární dokončení (Odhadovaný)
1. července 2029
Dokončení studie (Odhadovaný)
1. července 2029
Termíny zápisu do studia
První předloženo
12. června 2026
První předloženo, které splnilo kritéria kontroly kvality
12. června 2026
První zveřejněno (Aktuální)
18. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
18. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- E/26-045
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Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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Myungmoon Pharma. Co. Ltd.NáborCholesterol cholelithiasisJižní Korea
Klinické studie na EUS-guided gallbladder drainage (EUS-GBD)
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Fundacion Miguel ServetNáborCholecystitida, akutníŠpanělsko