Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
EXCLUSION CRITERIA
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. | ||
| 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.
| ||
| Patients suitable for Surgery with low risk | Admission in Surgery Department. According to the AC severity:
|
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Inclusion rate | Rate of patients with AC diagnosis registered in the study | During inclusion period |
| Protocol compliance | Rate of patients with complete protocol compliance | During inclusion period |
| Morbidity in the different subtypes of patients | length of hospital stay, need for unplanned readmissions, recurrent cholecystitis | three months after hospital discharge |
| Mortality in the different subtypes of patients | 90-day disease-specific mortality | three months after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Protocol compliance failure | Identify causes of protocol compliance failure | every 3 months throughout study completion (up to 1 year) |
| Evaluate the technical success | Evaluate clinical success and adverse events of the different treatments. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients attended in the emergency department of CHN and diagnosed with acute cholecystitis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federico Bolado Concejo, MD, PhD | Contact | 0034848422025 | fboladoc@cfnavarra.es | |
| Ruth Garcia Rey, MS | Contact | 0034848422163 | ruth.garcia.rey@navarra.es |
| Name | Affiliation | Role |
|---|---|---|
| Federico Bolado Concejo, MD, PhD | Complejo Hospitalario de Navarra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29032636 | Background | 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. | |
| 27307785 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 28, 2020 | Dec 10, 2020 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| During inclusion period (up to 1 year) |
| 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 |
| Background |
| 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. |
| 30465770 | Background | 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. |
| 20105473 | Background | 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. |
| 30979521 | Background | 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. |
| 30943551 | Background | 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. |
| 31238375 | Background | 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. |