Evaluation of a Protocol for Multidisciplinary Management of Acute Cholecystitis.

Acute Cholecystitis Clinical Trial

Official title:

Evaluation of the Applicability and Effectiveness of a Protocol for the Multidisciplinary Management of Acute Cholecystitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04543578
• Other study ID #: DIGESTIVO CHN-VBP
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: January 2023

Study information

• Verified date: December 2020
• Source: Fundacion Miguel Servet
• Contact: Federico Bolado Concejo, MD, PhD
• Phone: 0034848422025
• Email: fboladoc[@]cfnavarra.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute cholecystitis is a complex disease and its management is sometimes controversial. Two main factors contribute to its complexity: the patient's surgical risk and the possibility of concomitant choledocholithiasis. The design of a multidisciplinary protocol between the services of Gastroenterology and Surgery aims to harmonize its management and to adapt it to the most recent guidelines. As it concerns more than one department, it is crucial to analyze its compliance and effectiveness.

Description:

Adult patients attending the emergency department and diagnosed with acute cholecystitis will be asked to participate. Those considered not suitable for surgery will be admitted in a medical department and assigned to conservative treatment or cholecystostomy, according to their acute cholecystitis severity. In patients suitable for surgery, risk of concomitant choledocholithiasis will be assessed and patients will be assigned to low risk or intermediate-high risk. The latter will be admitted in a medical department, and choledocholithiasis will be ruled out and treated if present. The former will be offered cholecystectomy or cholecystostomy according to their surgical risk and acute cholecystitis severity. A flowchart with extended information is attached. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Locations

Country	Name	City	State
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion Miguel Servet

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. Review. Erratum in: World J Emerg Surg. 2016 Nov 4;11:52. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, Giménez ME, de Santibañes 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inclusion rate	Rate of patients with AC diagnosis registered in the study	During inclusion period
Primary	Protocol compliance	Rate of patients with complete protocol compliance	During inclusion period
Primary	Morbidity in the different subtypes of patients	length of hospital stay, need for unplanned readmissions, recurrent cholecystitis	three months after hospital discharge
Primary	Mortality in the different subtypes of patients	90-day disease-specific mortality	three months after hospital discharge
Secondary	Protocol compliance failure	Identify causes of protocol compliance failure	every 3 months throughout study completion (up to 1 year)
Secondary	Evaluate the technical success	Evaluate clinical success and adverse events of the different treatments.	During inclusion period (up to 1 year)
Secondary	Evaluate the accuracy in the diagnosis	Evaluate the accuracy of Magnetic Resonance Cholangiopancreatography (MRCP) and EUS in the diagnosis of concomitant choledocholithiasis	three months after hospital discharge or after ERCP