Risk Factors for Major Complications After Liver Resection

Liver Diseases Clinical Trial

Official title:

Risk Factors for Major Complications After Liver Resection: Audit of a Non-Eastern/Non-Western Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03967067
• Other study ID #: LiverResection
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2019
• Source: Moroccan Society of Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to determine the risk factors for major complications following liver resection in the setting of a general surgery-teaching department in Morocco, North Africa

Description:

Over the past 20 years, the refinement of liver surgery techniques, anesthesiology and perioperative management has dramatically improved the safety of liver resection patients. It has also led to a concomitant extension of indications for a growing number of patients with complex benign or malignant hepatobiliary diseases and/or high risk surgeries.

Published complication rates and risk prediction models and recommendations for patients undergoing liver resection primarily stem from far East or Western high-volume specialized centers. In developing countries, including those in North Africa, specific constraints (e.g., endemic indications, such as liver cystic hydatidosis, blood shortage, and the scarcity of liver surgeons and intensive care providers) may impact liver resection outcomes but they are rarely addressed in the literature.

The aim of this study was to determine the risk factors for major complications following liver resection in the setting of a general surgery-teaching department in Morocco, North Africa

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: December 31, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients who underwent an hepatectomy

• between january 2010 and December 2015

Exclusion Criteria:

• All patient who only underwent liver biopsy with no resection

• Patients non operated

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Procedure:
• liver resection
Open or laparoscopic, major or minor hepatectomy performed using the clamp-crush technique and intermittent clamping of hepatic pedicle

Locations

Country	Name	City	State
Morocco	Ibn Sina Hospital, Surgical department A	Rabat

Sponsors (1)

Lead Sponsor	Collaborator
Moroccan Society of Surgery

Country where clinical trial is conducted

Morocco, 

References & Publications (5)

Benkabbou A, Souadka A, Serji B, Hachim H, Mohsine R, Ifrine L, Belkouchi A, El Malki HO. Changing paradigms in the surgical management of cystic liver hydatidosis improve the postoperative outcomes. Surgery. 2016 Apr;159(4):1170-80. doi: 10.1016/j.surg.2015.10.029. Epub 2015 Dec 31. — View Citation

Dokmak S, Ftériche FS, Borscheid R, Cauchy F, Farges O, Belghiti J. 2012 Liver resections in the 21st century: we are far from zero mortality. HPB (Oxford). 2013 Nov;15(11):908-15. doi: 10.1111/hpb.12069. Epub 2013 Mar 6. — View Citation

Galun DA, Bulajic P, Zuvela M, Basaric D, Ille T, Milicevic MN. Is there any benefit from expanding the criteria for the resection of hepatocellular carcinoma in cirrhotic liver? Experience from a developing country. World J Surg. 2012 Jul;36(7):1657-65. doi: 10.1007/s00268-012-1544-x. — View Citation

Lim C, Dejong CH, Farges O; e-HPBchir Study Group from the Association de Chirurgie Hépato-Biliaire et de Transplantation (ACHBT) (Association of Hepatobilary and Transplant Surgery). Improving the quality of liver resection: a systematic review and critical analysis of the available prognostic models. HPB (Oxford). 2015 Mar;17(3):209-21. doi: 10.1111/hpb.12346. Epub 2014 Oct 17. — View Citation

Mann CD, Palser T, Briggs CD, Cameron I, Rees M, Buckles J, Berry DP. A review of factors predicting perioperative death and early outcome in hepatopancreaticobiliary cancer surgery. HPB (Oxford). 2010 Aug;12(6):380-8. doi: 10.1111/j.1477-2574.2010.00179.x. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90-day Mortality rate	Death within 90 days of surgical procedure	90 days from surgery
Primary	90-day Complication rate	Defined by Clavien-Dindo grade I to IV within90 days of surgical procedure	90 days from surgery
Secondary	Risk factor of major complication at 90-day	defined by multivariate logistic regression of 90 day complication with Clavien-Dindo more than grade III	90 days from surgery