Skip to main content
Clinical Trials/NCT05202457
NCT05202457CompletedNot Applicable

Review of Outcomes in Patients With Cirrhosis Undergoing General Surgery

Danny Lascano1 site in 1 country63 target enrollmentStarted: June 27, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
63
Locations
1
Primary Endpoint
Number of patients that die at 30, 90 and 365 days after index surgery

Study Overview

Brief Summary

Surgery on cirrhotic patients represents a clinical challenge but intervening before these patients develop complications can prolong the likelihood of these patients making it to transplant for those transplant-eligible candidates. There is no literature on survival to transplant afforded by surgery nor 90 day and 1-year outcomes after any surgical procedures on this population. The investigator's aim is to study the principal investigator's single surgical center experience at a tertiary hospital with the largest referral center in the area for liver transplant candidates. The investigators hypothesize, that although the risk is high for patients undergoing surgery it is much lower than historically reported, may make more patients eligible for transplant and prevent complications that may lead to death for the transplant eligible, and may reveal associations that can lead to good outcomes in this high-risk population.

Detailed Description

Introduction

The incidence of cirrhosis is increasing as alcoholic liver disease overtakes hepatitis as the cause of cirrhosis although it will likely stabilize as Hepatitis C treatment makes its way through the population. However, liver disease continues to have a large impact on morbidity and mortality with a prevalence of approximately 4.5 million people diagnosed with liver disease with an incidence of 1.8% per year and 12.8 deaths per 100,000 people. The cost of treating cirrhosis ranges from $14 million to $2 billion dollars depending on the etiology of the disease. The large cost is driven by multiple hospitalizations, surgical procedures, rehabilitation/nursing home, and other factors.

For surgeons, cirrhotic patients represent an especially high-risk patient population. In the past, many surgeons were hesitant to offer definitive surgeries for symptomatic cholelithiasis, hernias, or cancer surgeries. Historically these patients had a high risk of mortality with competing causes of mortality driven by liver cirrhosis as well as other issues. Hence, it was thought that these patients should only be operated on in emergent cases unless it precluded them from being transplant eligible. For example, Garrison, et al. noted in 1984 that patients who underwent exploratory laparotomy with either a Child B and C had a 31% and 76% mortality, respectively. Furthermore, this was not unique to that group as another group in 1997 showed surgeries like hernia procedures, cholecystectomy, and other procedures had mortality rates of up to 82% for Child C cirrhotics. As general post-surgical care and critical care have improved, contemporary studies show that mortality although decreased still is significant. A prospective study looking at cirrhotic patients who underwent an umbilical hernia for 30 patients had a mortality of 6%. Moreover, a retrospective analysis of a prospectively maintained database from the American College of Surgeons National Surgical Quality Improvement Program revealed that in a series of 390 pts undergoing umbilical hernia repair there was a 5.1% mortality and 13.1% morbidity in comparison to 0.1 and 3.9% on non-cirrhotic patients, respectively.

There are few papers that look at the drivers of morbidity, mortality, and complications among this population and none looking at more than 30 days post-operative re-admissions, morbidity, or mortality. Furthermore, there is no literature on how elective or emergent surgery may facilitate a longer survival so that patients may still be alive and eligible to receive their liver, the ultimate treatment for liver cirrhosis. Hence, the investigator's tertiary center experience was evaluated focusing on pre-operative, intraoperative, and postoperative factors that may explain the drivers of morbidity and mortality in cirrhotics undergoing elective and emergent surgery. The investigators will also study at how many patients after their index procedure survived to receive their liver transplant. Hence, the investigator's surgical, single-center experience at a tertiary hospital with the largest referral center in the area for liver transplant candidates for any cirrhotics requiring surgery either emergent (<24 hours since admission), urgent (same admission but > 24 hrs), or elective (patient coming from outpatient setting for planned surgery). The investigators hypothesize, that although the risk is high for patients undergoing surgery, it currently is much lower than historically reported, which may make more patients eligible for transplant and prevent complications that may lead to death for the transplant eligible patients, and may reveal associations that can lead to good outcomes in this high-risk population.

Materials and Methods

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All non-transplant surgical procedures by the principal investigator over a 5-year period (2013-2018)
  • Patients with a known, symptomatic and documented pre-operative history of cirrhosis

Exclusion Criteria

  • Asymptomatic or incidentally discovered cirrhosis

Outcomes

Primary Outcomes

Number of patients that die at 30, 90 and 365 days after index surgery

Time Frame: 1 year

Death within 30, 90 and 365 days after surgery

Secondary Outcomes

  • Number of patients that have a complication at 30, 90 and 365 days after index surgery(1 year)
  • Number of patients that receive a liver transplant after their index surgery(1 year)

Investigators

Sponsor
Danny Lascano
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Danny Lascano

Research Resident

Westchester Medical Center

Study Sites (1)

Loading locations...

Similar Trials