Evaluation of a Protocol for Multidisciplinary Management of Acute Cholecystitis.
NCT ID: NCT04543578
Last Updated: 2020-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2020-07-01
2023-01-31
Brief Summary
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Detailed Description
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PRIMARY OBJECTIVES
• To harmonize the management of acute cholecystitis with a multidisciplinary protocol based on the most recent guidelines.
SECONDARY OBJECTIVES
* To analyze the compliance with this protocol.
* To evaluate the validity of the criteria used in the decision-making process.
* To assess the morbidity and mortality of different groups of patients according to the selected treatment, severity of cholecystitis and baseline characteristics of the patient.
* To estimate the resource use in each group of patients.
* To compare current data with a previous period.
* To adapt and modify the protocol according the study results. INCLUSION CRITERIA
* Patients aged 18 or older who agree to participate (an informed consent signature is required)
* Patients attended in the emergency department of our hospital and diagnosed with acute cholecystitis according to the Tokyo criteria.
EXCLUSION CRITERIA
* Patients under 18 years or patients who refuse to participate in the study
* Patients diagnosed with acute cholangitis during admission for other causes.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients unfit for Surgery with mild-moderate acute cholecyst
Conservative treatment (antibiotics, etc). EUS-guided gallbladder drainage will be considered in recurrent acute cholecystitis and in patients with no improvement in 48-72h after admission.
No interventions assigned to this group
Patients unfit for Surgery with severe acute cholecystitis
Percutaneous cholecystostomy or Endoscopic Ultrasound (EUS)-guided cholecystostomy (the latter is not 24/7 available). Palliative care may also be considered in patients with very serious conditions and low life expectancy.
No interventions assigned to this group
Patients suitable for Surgery with high and intermediate risk
Admission in Gastroenterology Department. antibiotic treatment. Close follow-up of posible AC complications. Once choledocholithiasis is solved or ruled our, the patient will be considered for same-admission cholecystectomy or programmed cholecystectomy.
* High risk: Endoscopic Retrograde Cholangiopancreatography (ERCP) will be performed.
* Intermediate risk: EUS or Magnetic Resonance Cholangiopancreatography prior to consider ERCP.
No interventions assigned to this group
Patients suitable for Surgery with low risk
Admission in Surgery Department. According to the AC severity:
* Mild-moderate AC: check de ASA/Charlson comorbidity index.
* ASA I-II/Charlson \<6: laparoscopic cholecystectomy
* ASA \> =III/Charlson \>=6: close follow-up 24-48h. Consider laparoscopic cholecystostomy (if no improvement is achieved)
* Severe AC: consider Intensive Care Unit admission. Percutaneous cholecystectomy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients attended in the emergency department of our hospital and diagnosed with acute cholecystitis according to the Tokyo criteria.
Exclusion Criteria
* Patients diagnosed with acute cholangitis during admission for other causes.
18 Years
ALL
No
Sponsors
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Fundacion Miguel Servet
OTHER
Responsible Party
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Principal Investigators
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Federico Bolado Concejo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Complejo Hospitalario de Navarra
Locations
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Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Countries
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Central Contacts
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Facility Contacts
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Federico Bolado Concejo, MD, PhD
Role: primary
Ruth García Rey, MSc
Role: backup
References
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Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Gimenez ME, de Santibanes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9.
Ansaloni L, Pisano M, Coccolini F, Peitzmann AB, Fingerhut A, Catena F, Agresta F, Allegri A, Bailey I, Balogh ZJ, Bendinelli C, Biffl W, Bonavina L, Borzellino G, Brunetti F, Burlew CC, Camapanelli G, Campanile FC, Ceresoli M, Chiara O, Civil I, Coimbra R, De Moya M, Di Saverio S, Fraga GP, Gupta S, Kashuk J, Kelly MD, Koka V, Jeekel H, Latifi R, Leppaniemi A, Maier RV, Marzi I, Moore F, Piazzalunga D, Sakakushev B, Sartelli M, Scalea T, Stahel PF, Taviloglu K, Tugnoli G, Uraneus S, Velmahos GC, Wani I, Weber DG, Viale P, Sugrue M, Ivatury R, Kluger Y, Gurusamy KS, Moore EE. 2016 WSES guidelines on acute calculous cholecystitis. World J Emerg Surg. 2016 Jun 14;11:25. doi: 10.1186/s13017-016-0082-5. eCollection 2016.
Chisholm PR, Patel AH, Law RJ, Schulman AR, Bedi AO, Kwon RS, Wamsteker EJ, Anderson MA, Elta GH, Govani SM, Prabhu A. Preoperative predictors of choledocholithiasis in patients presenting with acute calculous cholecystitis. Gastrointest Endosc. 2019 May;89(5):977-983.e2. doi: 10.1016/j.gie.2018.11.017. Epub 2018 Nov 19.
ASGE Standards of Practice Committee; Maple JT, Ben-Menachem T, Anderson MA, Appalaneni V, Banerjee S, Cash BD, Fisher L, Harrison ME, Fanelli RD, Fukami N, Ikenberry SO, Jain R, Khan K, Krinsky ML, Strohmeyer L, Dominitz JA. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc. 2010 Jan;71(1):1-9. doi: 10.1016/j.gie.2009.09.041. No abstract available.
ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.
Manes G, Paspatis G, Aabakken L, Anderloni A, Arvanitakis M, Ah-Soune P, Barthet M, Domagk D, Dumonceau JM, Gigot JF, Hritz I, Karamanolis G, Laghi A, Mariani A, Paraskeva K, Pohl J, Ponchon T, Swahn F, Ter Steege RWF, Tringali A, Vezakis A, Williams EJ, van Hooft JE. Endoscopic management of common bile duct stones: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2019 May;51(5):472-491. doi: 10.1055/a-0862-0346. Epub 2019 Apr 3.
Luk SW, Irani S, Krishnamoorthi R, Wong Lau JY, Wai Ng EK, Teoh AY. Endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for high risk surgical patients with acute cholecystitis: a systematic review and meta-analysis. Endoscopy. 2019 Aug;51(8):722-732. doi: 10.1055/a-0929-6603. Epub 2019 Jun 25.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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DIGESTIVO CHN-VBP
Identifier Type: -
Identifier Source: org_study_id