EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study (DRECON)
2026年6月17日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
110
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Emma Sudrià López
- 電話番号：937 36 50 50
- メール：malaltiaceliaca@mutuaterrrassa.cat
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
アクティブコンパレータ：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).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical biliary recurrence rate at 1-year follow-up
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- Tyberg A, Duarte-Chavez R, Shahid HM, Sarkar A, Simon A, Shah-Khan SM, Gaidhane M, Mohammad TF, Nosher J, Wise SS, Needham V, Kheng M, Lajin M, Sojitra B, Wey B, Dorwat S, Raina H, Ansari J, Gandhi A, Bapaye A, Shah-Khan SM, Krafft MR, Thakkar S, Singh S, Bane JR, Nasr JY, Lee DP, Kedia P, Arevalo-Mora M, Del Valle RS, Robles-Medranda C, Puga-Tejada M, Vanella G, Ardengh JC, Bilal M, Giuseppe D, Arcidiacono PG, Kahaleh M. Endoscopic Ultrasound-Guided Gallbladder Drainage Versus Percutaneous Drainage in Patients With Acute Cholecystitis Undergoing Elective Cholecystectomy. Clin Transl Gastroenterol. 2023 Jun 1;14(6):e00593. doi: 10.14309/ctg.0000000000000593.
- 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.
- Ghose K, Waheed A, Khan S, Losier D, Heshma AVC, Bhatia A, Mehta D, Abbas A, Khan IY, Allahi I, Ayyan M, Shahzil M, Nabeel A, Iqbal A, Awan RU. Conservative Management Versus Early Cholecystectomy for Gallstone Disease: A Meta-Analysis of Randomized Controlled Trials. JGH Open. 2025 Aug 13;9(8):e70253. doi: 10.1002/jgh3.70253. eCollection 2025 Aug.
- Morris-Stiff G, Sarvepalli S, Hu B, Gupta N, Lal P, Burke CA, Garber A, McMichael J, Rizk MK, Vargo JJ, Ibrahim M, Rothberg MB. The Natural History of Asymptomatic Gallstones: A Longitudinal Study and Prediction Model. Clin Gastroenterol Hepatol. 2023 Feb;21(2):319-327.e4. doi: 10.1016/j.cgh.2022.04.010. Epub 2022 May 2.
- Kousgaard N, Rasmussen SKM, Moller S, Koulaouzidis A, Mark-Christensen A. Symptomatic uncomplicated gallstone disease is associated with a high short-term risk of gallstone-related complications: a contemporary cohort study. Scand J Gastroenterol. 2024 Aug;59(8):954-960. doi: 10.1080/00365521.2024.2361756. Epub 2024 Jul 1.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2029年7月1日
研究の完了 (推定)
2029年7月1日
試験登録日
最初に提出
2026年6月12日
QC基準を満たした最初の提出物
2026年6月12日
最初の投稿 (実際)
2026年6月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月22日
QC基準を満たした最後の更新が送信されました
2026年6月17日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- E/26-045
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。