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出境医 / 临床实验 / Risk Factors for Major Complications After Liver Resection

Risk Factors for Major Complications After Liver Resection

Study Description
Brief 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

Condition or disease Intervention/treatment
Liver Diseases Procedure: liver resection

Detailed 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

Study Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 213 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Factors for Major Complications After Liver Resection: Audit of a Non-Eastern/Non-Western Experience
Actual Study Start Date : January 1, 2010
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : December 31, 2016
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 90-day Mortality rate [ Time Frame: 90 days from surgery ]
    Death within 90 days of surgical procedure

  2. 90-day Complication rate [ Time Frame: 90 days from surgery ]
    Defined by Clavien-Dindo grade I to IV within90 days of surgical procedure


Secondary Outcome Measures :
  1. Risk factor of major complication at 90-day [ Time Frame: 90 days from surgery ]
    defined by multivariate logistic regression of 90 day complication with Clavien-Dindo more than grade III


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date May 26, 2019
First Posted Date May 30, 2019
Last Update Posted Date May 30, 2019
Actual Study Start Date January 1, 2010
Actual Primary Completion Date March 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2019)
  • 90-day Mortality rate [ Time Frame: 90 days from surgery ]
    Death within 90 days of surgical procedure
  • 90-day Complication rate [ Time Frame: 90 days from surgery ]
    Defined by Clavien-Dindo grade I to IV within90 days of surgical procedure
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 26, 2019) 		Risk factor of major complication at 90-day [ Time Frame: 90 days from surgery ]
defined by multivariate logistic regression of 90 day complication with Clavien-Dindo more than grade III
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Factors for Major Complications After Liver Resection
Official Title Risk Factors for Major Complications After Liver Resection: Audit of a Non-Eastern/Non-Western Experience
Brief 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
Detailed 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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patient who underwent a liver resection in a sugical hepatobiliary department and who had underwent preoperative serum tests, imaging workup and multidisciplinary discussion, according to the indication for LR. Adequate imaging assessment included the calculation of the future remnant liver volume (RLV) using free software, as needed. Preoperative portal embolization or a 2-step approach, including ALPPS, was considered in non-cirrhotic cases with a RLV to body weight ratio <0.5%
Condition 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
Study Groups/Cohorts Not Provided
Publications *
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 26, 2019) 		213
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2016
Actual Primary Completion Date March 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Morocco
Removed Location Countries  
 
Administrative Information
NCT Number NCT03967067
Other Study ID Numbers LiverResection
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Moroccan Society of Surgery
Study Sponsor Moroccan Society of Surgery
Collaborators Not Provided
Investigators
Study Director: Abdelkader Belkouchi, MD Surgical department A Ibn Sina
PRS Account Moroccan Society of Surgery
Verification Date May 2019

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