NCT05202457

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

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

June 27, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

2 years

First QC Date

January 5, 2022

Last Update Submit

January 20, 2022

Conditions

Cirrhosis, Liver

Keywords

elective surgerycirrhoticscirrhosis

Outcome Measures

Primary Outcomes (1)

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

    Death within 30, 90 and 365 days after surgery

    1 year

Secondary Outcomes (2)

  • 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

Study Arms (1)

Cirrhosis

Patients with cirrhosis undergoing urgent and elective surgery

Procedure: Elective surgery

Interventions

Elective surgeryPROCEDURE

Patient undergoing elective or urgent surgery

Cirrhosis

Eligibility Criteria

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

Patients 18 years or over who presented to Westchester Medical Center, a quaternary hospital system in the Hudson Valley

You may qualify if:

  • 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

You may not qualify if:

  • Asymptomatic or incidentally discovered cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Related Publications (5)

  • Neff GW, Duncan CW, Schiff ER. The current economic burden of cirrhosis. Gastroenterol Hepatol (N Y). 2011 Oct;7(10):661-71.

    PMID: 22298959BACKGROUND

  • Garrison RN, Cryer HM, Howard DA, Polk HC Jr. Clarification of risk factors for abdominal operations in patients with hepatic cirrhosis. Ann Surg. 1984 Jun;199(6):648-55. doi: 10.1097/00000658-198406000-00003.

    PMID: 6732310BACKGROUND

  • Mansour A, Watson W, Shayani V, Pickleman J. Abdominal operations in patients with cirrhosis: still a major surgical challenge. Surgery. 1997 Oct;122(4):730-5; discussion 735-6. doi: 10.1016/s0039-6060(97)90080-5.

    PMID: 9347849BACKGROUND

  • Eker HH, van Ramshorst GH, de Goede B, Tilanus HW, Metselaar HJ, de Man RA, Lange JF, Kazemier G. A prospective study on elective umbilical hernia repair in patients with liver cirrhosis and ascites. Surgery. 2011 Sep;150(3):542-6. doi: 10.1016/j.surg.2011.02.026. Epub 2011 May 31.

    PMID: 21621237BACKGROUND

  • Cho SW, Bhayani N, Newell P, Cassera MA, Hammill CW, Wolf RF, Hansen PD. Umbilical hernia repair in patients with signs of portal hypertension: surgical outcome and predictors of mortality. Arch Surg. 2012 Sep;147(9):864-9. doi: 10.1001/archsurg.2012.1663.

    PMID: 22987183BACKGROUND

Related Links

MeSH Terms

Conditions

Liver CirrhosisFibrosis

Interventions

Elective Surgical Procedures

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Gregory Veillette, MD

    Westchester Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Resident

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 21, 2022

Study Start

June 27, 2017

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

January 21, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Given the low number of patients and risk of identification, decision has been made not to share this data.

Locations

US(1)