Cirrhosis, LiverNCT05202457
Cirrhotics Undergoing General Surgery
An observational study of Cirrhosis, Liver, run by Danny Lascano at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Elective surgery
- Type of treatment
- Surgery or procedure
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2017to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years or over who presented to Westchester Medical Center, a quaternary hospital system in the Hudson Valley
Who may be able to join
- 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
Who cannot join
- Asymptomatic or incidentally discovered cirrhosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: Review of Outcomes in Patients With Cirrhosis Undergoing General Surgery
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.
Read the 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
The investigator's institutional review board approved this study and data were collected in a retrospective fashion. Initially, a query was done looking at all participants with cirrhosis who underwent any procedure done by the principal investigator. After this, a chart review was done looking at all the participants with a diagnosis of cirrhosis via manual chart review. The index procedure, as well as any re-operation done, were included and all performed by the surgeon who is the principal investigator. Furthermore, pre-operative data that was collected included medications used to treat cirrhosis, etiology of cirrhosis, biological Na-MELD/ Child's classification, whether a transjugular intrahepatic portosystemic shunt was performed, the incidence of esophageal varices/ ascites, pre-operative drainage of ascites or placement of a drain as well as cases of refractory ascites.
Furthermore, intraoperative data were obtained from the anesthesia records regarding estimated blood loss, crystalloid/ colloid administered, blood products administered, any episodes of hypotension, and the use of vasopressors. Post-operative data collected included any complications, blood products administered, the use of colloids, and finally the date of discharge. The participants were tracked for over a year and any cases of re-admission were noted from the charts and the causes of re-admission were noted for further analysis.
Data was collected in a de-identified fashion. Comparisons were done via Student T-tests when applicable. Logistic regression was done to identify factors associated with a given outcome including morbidity and mortality with a limit of 3 factors chosen in a univariable model and multivariable model given the low number of cases. Kaplan Meier curves were done to analyze the time to transplant after elective surgery to analyze whether elective surgery may increase the life span of cirrhotics who undergo surgery and stratifying by different risk factors to predict who may need a transplant sooner after elective surgery. Data were analyzed via SPSS 26.0.
- Conditions
- Cirrhosis, Liver
- Being tested
- Elective surgery
- Keywords
- elective surgery, cirrhotics, cirrhosis
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective surgeryProcedure or surgery
Patient undergoing elective or urgent surgery
| Study group | Role | What they receive |
|---|---|---|
| Cirrhosis | Patients with cirrhosis undergoing urgent and elective surgery Receives: Procedure: Elective surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that die at 30, 90 and 365 days after index surgery
Death within 30, 90 and 365 days after surgery
Measured: 1 year
Secondary outcomes (2)
Number of patients that have a complication at 30, 90 and 365 days after index surgery
Complications within 30, 90 and 365 days after surgery
Measured: 1 year
Number of patients that receive a liver transplant after their index surgery
Number of patients who make it to surgery af their index surgical procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start27 Jun 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danny Lascano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Danny Lascano, Westchester Medical Center
- Investigators
- Gregory Veillette, MD, Principal investigator, Westchester Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202457
- Sponsor's protocol ID
- L12-124
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Given the low number of patients and risk of identification, decision has been made not to share this data.
Publications
Neff GW, Duncan CW, Schiff ER. The current economic burden of cirrhosis. Gastroenterol Hepatol (N Y). 2011 Oct;7(10):661-71.
PubMed 22298959Garrison 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.
PubMed 6732310Mansour 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.
PubMed 9347849Eker 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.
PubMed 21621237Cho 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.
PubMed 22987183
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Review of Outcomes in Patients With Cirrhosis Undergoing General Surgery
- ClinicalTrials.gov ID
- NCT05202457
- Acronym / sponsor ID
- L12-124
- Conditions
- Cirrhosis, Liver
- Keywords
- elective surgery, cirrhotics, cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Danny LascanoUniversity, hospital or other
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The investigator's institutional review board approved this study and data were collected in a retrospective fashion. Initially, a query was done looking at all participants with cirrhosis who underwent any procedure done by the principal investigator. After this, a chart review was done looking at all the participants with a diagnosis of cirrhosis via manual chart review. The index procedure, as well as any re-operation done, were included and all performed by the surgeon who is the principal investigator. Furthermore, pre-operative data that was collected included medications used to treat cirrhosis, etiology of cirrhosis, biological Na-MELD/ Child's classification, whether a transjugular intrahepatic portosystemic shunt was performed, the incidence of esophageal varices/ ascites, pre-operative drainage of ascites or placement of a drain as well as cases of refractory ascites.
Furthermore, intraoperative data were obtained from the anesthesia records regarding estimated blood loss, crystalloid/ colloid administered, blood products administered, any episodes of hypotension, and the use of vasopressors. Post-operative data collected included any complications, blood products administered, the use of colloids, and finally the date of discharge. The participants were tracked for over a year and any cases of re-admission were noted from the charts and the causes of re-admission were noted for further analysis.
Data was collected in a de-identified fashion. Comparisons were done via Student T-tests when applicable. Logistic regression was done to identify factors associated with a given outcome including morbidity and mortality with a limit of 3 factors chosen in a univariable model and multivariable model given the low number of cases. Kaplan Meier curves were done to analyze the time to transplant after elective surgery to analyze whether elective surgery may increase the life span of cirrhotics who undergo surgery and stratifying by different risk factors to predict who may need a transplant sooner after elective surgery. Data were analyzed via SPSS 26.0.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis | – | Procedure: Elective surgeryPatients with cirrhosis undergoing urgent and elective surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years or over who presented to Westchester Medical Center, a quaternary hospital system in the Hudson Valley
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Asymptomatic or incidentally discovered cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective surgeryPatient undergoing elective or urgent surgery | Procedure or surgery | Cirrhosis |
Primary outcome
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
2 secondary outcomes
Number of patients that have a complication at 30, 90 and 365 days after index surgery
Time frame: 1 year
Number of patients that receive a liver transplant after their index surgery
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
- Background: PubMed 22298959Neff GW, Duncan CW, Schiff ER. The current economic burden of cirrhosis. Gastroenterol Hepatol (N Y). 2011 Oct;7(10):661-71.
- Background: PubMed 6732310Garrison 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.
- Background: PubMed 9347849Mansour 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.
- Background: PubMed 21621237Eker 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.
- Background: PubMed 22987183Cho 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.
- Data regarding incidence/ prevalence of cirrhosis in the USLink provided by the sponsor.
- Individual participant dataSharing planned: No. Given the low number of patients and risk of identification, decision has been made not to share this data.
Related trials for Cirrhosis, Liver
Enrolling by invitationPhase 2/3
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
Primary Biliary Cholangitis (PBC)
Not yet recruiting
Prickly Pear Pulp Powder Along With an Anti-inflammatory Diet in Patients Having Liver Fibrosis
Lipid Profile, Blood Glucose
Active, not recruitingPhase 2/3
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis
Primary Biliary Cholangitis
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Veillette, MD principal investigator
Westchester Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver, run by Danny Lascano at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that die at 30, 90 and 365 days after index surgery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05202457, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2022.