Liver Resection and Simultaneous Sleeve Gastrectomy for MS-HCC (LIRESS)

NCT06060847 | Not Yet Recruiting

• 1 other identifier: 3/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma (HCC) related to metabolic syndrome (MS) as unique risk factor is gradually overpassing the more common viral and alcohol etiology, becoming a global health issue. Liver surgery for metabolic syndrome-related HCC in this frail subset of patients constitute a challenge, due to high morbidity and mortality rate reported in literature, and contrasting results in term of oncologic outcome. The present multicentric prospective study aims to ascertain if the combination of sleeve gastrectomy and liver surgery in the same surgical procedure may have benefit in terms of reduced perioperative morbidity and prolonged Overall Survival and Recurrence Free Survival. Secondary outcome will be the evaluation of the consequences induced by sleeve gastrectomy on liver disease, in particular liver fibrosis evaluated in term of NFS score (Non-Alcoholic Fatty Liver Disease Fibrosis score), FIB-4 (Fibrosis-4 Index for Liver Fibrosis) score and Fibroscan transient elastography.

Conditions

Carcinoma, Hepatocellular; Metabolic Syndrome

Keywords

hepatocellular carcinoma; sleeve gastrectomy; morbid obesity

Outcome Measures

Primary Outcomes (4)

• Overall Survival

  Calculated from the date of diagnosis to the date of death from any cause

  1 year, 3 years, 5 years

• Recurrence-free Survival

  Calculated from the date of surgery to the date of recurrence

  1 year, 3 years, 5 years

• 90-day mortality

  Mortality from any cause

  90 post-operative days

• Comprehensive Complication Index

  Any deviation from the normal postoperative course measured on a scale from 0 (no complication) to 100 (death)

  90 post-operative days

Secondary Outcomes (8)

• Fibrosis-4 Index for Liver Fibrosis score

  After 6 months, up to 5 years

• Non-Alcoholic Fatty Liver Disease Fibrosis Score

  After 6 months, up to 5 years

• Fibroscan stiffness

  After 6 months, up to 5 years

• Body Mass Index

  After 3 months, up to 5 years

• Weight loss

  After 3 months, up to 5 years

Study Arms (2)

Patients affected by HCC induced by metabolic syndrome as unique risk factor

EXPERIMENTAL

Patients aged 18 years old and older, affected by HCC with MS (metabolic syndrome) as unique risk factor who comply with the criteria for bariatric surgery, will undergo liver resection and sleeve gastrectomy with minimally-invasive technique in the same surgical procedure

Procedure: Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome

Patients with HCC related to metabolic syndrome as unique risk factor

ACTIVE COMPARATOR

Patients aged 18 years old and older, affected by HCC (hepatocellular carcinoma) with MS (metabolic syndrome) as unique risk factor who will undergo liver resection only

Procedure: Liver resection for HCC induced by metabolic syndrome

Interventions

Liver resection and simultaneous sleeve gastrectomy for HCC induced by metabolic syndrome PROCEDURE

Patients in the experimental arm will undergo liver resection for HCC and sleeve gastrectomy for MS during the same surgical procedure.

Patients affected by HCC induced by metabolic syndrome as unique risk factor

Liver resection for HCC induced by metabolic syndrome PROCEDURE

Patients in the active comparator arm will undergo liver resection for HCC

Patients with HCC related to metabolic syndrome as unique risk factor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be willing and able to provide written informed consent/assent for the trial
• Be ≥ 18 years of age on day of signing informed consent.
• Have hepatocellular carcinoma with metabolic syndrome as unique risk factor
• Have an overall Child-Pugh score = A
• Be eligible for liver resection with laparoscopic or robotic technique
• Be eligible for bariatric surgery as defined below
• BMI ≥ 40 kg/m2
• BMI ≥ 35-40 kg/m2 with associated comorbidities
• BMI 30-35 kg/m2 and type 2 diabetes
• BMI 30-35 kg/m2 and arterial hypertension with poor control despite optimal medical therapy.

You may not qualify if:

• Have hepatocellular carcinoma related to other etiology, even in case of coexisting metabolic syndrome
• Denial of the patient to undergo bariatric procedure
• Have BMI \< 30
• Have negative opinion of psychologic consultant
• Have an overall Child-Pugh score \> 7
• Evidence of clinical significant portal hypertension as followed:
• esophageal varices
• gastric varices
• portal hypertensive gastropathy
• gastric vascular ectasia

Sponsors & Collaborators

• Ospedale V. Fazzi: lead

Study Sites (1)

Ospedale Vito Fazzi

Lecce, 73100, Italy

Location

Related Publications (4)

• Yang T, Hu LY, Li ZL, Liu K, Wu H, Xing H, Lau WY, Pawlik TM, Zeng YY, Zhou YH, Gu WM, Wang H, Chen TH, Han J, Li C, Wang MD, Wu MC, Shen F. Liver Resection for Hepatocellular Carcinoma in Non-alcoholic Fatty Liver Disease: a Multicenter Propensity Matching Analysis with HBV-HCC. J Gastrointest Surg. 2020 Feb;24(2):320-329. doi: 10.1007/s11605-018-04071-2. Epub 2019 Jan 7.

  PMID: 30617773 BACKGROUND

• Cauchy F, Zalinski S, Dokmak S, Fuks D, Farges O, Castera L, Paradis V, Belghiti J. Surgical treatment of hepatocellular carcinoma associated with the metabolic syndrome. Br J Surg. 2013 Jan;100(1):113-21. doi: 10.1002/bjs.8963. Epub 2012 Nov 12.

  PMID: 23147992 BACKGROUND

• de Barros F, Cardoso Faleiro Uba PH. Liver transplantation and bariatric surgery: a new surgical reality: a systematic review of the best time for bariatric surgery. Updates Surg. 2021 Oct;73(5):1615-1622. doi: 10.1007/s13304-021-01106-3. Epub 2021 Jun 12.

  PMID: 34118015 BACKGROUND

• Hobeika C, Ronot M, Beaufrere A, Paradis V, Soubrane O, Cauchy F. Metabolic syndrome and hepatic surgery. J Visc Surg. 2020 Jun;157(3):231-238. doi: 10.1016/j.jviscsurg.2019.11.004. Epub 2019 Dec 19.

  PMID: 31866269 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Metabolic Syndrome; Obesity, Morbid

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Annarita Libia

  Ospedale Vito Fazzi, Lecce

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annarita Libia

CONTACT

0039 0833335284; libiamd@me.com

Annarita Libia

CONTACT

0039 0833335285; libiamd@me.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Patients 18 years old and older, affected by hepatocellular carcinoma (HCC) with metabolic syndrome (MS) as unique risk factor, with compensated liver function (Child A) who are deemed suitable for liver resection and comply with the criteria for bariatric surgery, will undergo liver resection of HCC and simultaneous sleeve gastrectomy for morbid obesity during the same surgical procedure. Patients affected by HCC related to metabolic syndrome who fall within exclusion criteria, will undergo liver resection for HCC without sleeve gastrectomy.

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 29, 2023
• Study Start: March 6, 2024
• Primary Completion (Estimated): March 6, 2029
• Study Completion (Estimated): March 6, 2032
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

IT (1)