NCT04543578

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

2 years

First QC Date

September 2, 2020

Last Update Submit

December 10, 2020

Conditions

Acute Cholecystitis

Keywords

Acute cholecystitisEUS-guided cholecystostomyPercutaneous cholecystostomyLaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (3)

  • Protocol compliance failure

    every 3 months throughout study completion (up to 1 year)

  • Evaluate the technical success

    During inclusion period (up to 1 year)

  • Evaluate the accuracy in the diagnosis

    three months after hospital discharge or after ERCP

Study Arms (4)

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. * High risk: Endoscopic Retrograde Cholangiopancreatography (ERCP) will be performed. * Intermediate risk: EUS or Magnetic Resonance Cholangiopancreatography prior to consider ERCP.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attended in the emergency department of CHN and diagnosed with acute cholecystitis.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients under 18 years or patients who refuse to participate in the study
  • Patients diagnosed with acute cholangitis during admission for other causes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Related Publications (7)

  • 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.

    PMID: 29032636BACKGROUND

  • 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.

    PMID: 27307785BACKGROUND

  • 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.

    PMID: 30465770BACKGROUND

  • 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.

    PMID: 20105473BACKGROUND

  • 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.

    PMID: 30979521BACKGROUND

  • 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.

    PMID: 30943551BACKGROUND

  • 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.

    PMID: 31238375BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Federico Bolado Concejo, MD, PhD

    Complejo Hospitalario de Navarra

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Bolado Concejo, MD, PhD

CONTACT

0034848422025fboladoc@cfnavarra.es

Ruth Garcia Rey, MS

CONTACT

0034848422163ruth.garcia.rey@navarra.es

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2020

First Posted

September 10, 2020

Study Start

July 1, 2020

Primary Completion

July 1, 2022

Study Completion

January 1, 2023

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations

ES(1)