TANGO-LIVER Three Arm Nuclear Growth Observation in Liver Surgery

NCT06050200 | Recruiting DMC

• 1 other identifier: ABM24
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Liver resection is the treatment of choice in patients with malignant liver lesions. Unfortunately, the surgery is not always an option, as in same patients the future remnant liver (FRL) is too small to supply all the functions. Therefore, some additional methods have been proposed to increase the size of the FRL. The aim of this study is to compare the efficacy and safety of three methods of increasing the future remnant liver - Portal Vein Embolization (PVE) - embolization of one of the portal branches; Liver Vein Deprivation (LVD) - embolization both of the portal branch as well as the hepatic vein; and partial ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) - ligation of portal vein branch with partial liver transection. The efficacy of those three methods will be assessed both by analyzing the volumetric increase (by computer tomography scans) and by functional increase (by 99mTc-mebrofenin scintigraphy). Functional assessment of the liver hypertrophy seems to be of crucial importance, as some of the previous studies suggest that there might be a significant discrepancy in the increase of size comparing to the increase of function. This is a prospective, interventional randomized study. The study group (154 patients) will consist of patients being considered as candidates for major hepatic resection, after inducing hypertrophy of the future remnant liver. The primary study hypothesis is greater efficacy of ALPPS in preparing patients for large hepatic resection by inducing hypertrophy of the future remnant liver, as compared both to PVE and LVD. In case of unsuccessful induction of hypertrophy by the embolization techniques, patients may be qualified to rescue ALPPS procedure. Primary end-point: Percentage of patients with successful resection (patients, who gained sufficient increase of the FRL to proceed to the liver resection) with no post-surgical 90-day mortality. Secondary end-points:

1. 1.the rate and degree of volume increase in different groups
2. 2.the rate and degree of functional increase in different groups
3. 3.CCI index and complication rate \>=3 degree according to the Clavien-Dindo classification after the first stage of treatment
4. 4.CCI index and complication rate \>=3 degree according to the Clavien-Dindo classification after the second stage of treatment
5. 5.overall duration of hospital stay
6. 6.Embolization of portal vein branch (PVE, portal vein embolization)
7. 7.Embolization of both portal vein branch and hepatic vein (LVD, liver venous deprivation)
8. 8.Partial ALPPS (Associating Liver Partition and Portal vein Ligation for Staged hepatectomy) - ligation of portal vein branch with partial liver transection, preferentially by laparoscopic technique Computed tomography scans and scintigraphy will be repeated at day 7, 14 and 21 after the first stage of treatment. The second stage of treatment, the liver resection, will be performed after achievement of sufficient mebrofenin clearance rate (\>=2,69%/min/m2). In case of failure to reach the desired clearance rate, the measurements will be continued every 7 days up to day 42. In case of uncertainty and discrepancy between the volumetric assessment in the computed tomography scan and the mebrofenin scintigraphy, it will be allowed to proceed to stage two (partial hepatectomy) after joint consultation of at least 3 hepatobiliary surgeons, 1 radiologist and 1 nuclear medicine specialist. Routine blood tests will be performed according to the standard procedure in the Department, depending on the patient clinical status. An additional blood sample will be collected from patients (after receiving and additional informed consent from the patient) and will be stored in the biobank.

Conditions

Liver Metastases; Liver Cancer; Liver Neoplasms; Liver Metastasis Colon Cancer

Keywords

liver metastases; liver cancer; liver neoplasms; portal vein embolisation; liver venous deprivation; PVE; LVD; Associating Liver Partition and Portal vein Ligation for Staged hepatectomy; ALPPS; liver resection; mebrofenin scintigraphy; liver surgery

Outcome Measures

Primary Outcomes (1)

• Successful resection

  Percentage of patients with successful resection (patients, who gained sufficient increase of the FRL to proceed to the liver resection) with no post-surgical 90-day mortality.

  6 months

Secondary Outcomes (9)

• Change in future liver remnant volume over time

  42 days

• Total relative change of future liver remnant volume

  42 days

• Change in future liver remnant functional capacity over time

  42 days

• Total relative change in future liver remnant functional capacity

  42 days

• Severe morbidity after the first stage of treatment

  90 days

Study Arms (3)

PVE

ACTIVE COMPARATOR

Portal Vein Embolisation Patients in this group will undergo embolisation of branch of portal vein (interventional radiological procedure)

Procedure: PVE

LVD

ACTIVE COMPARATOR

Liver Venous Deprivation Patients in this group will undergo simultaneous embolization of branch of the portal vein and one or two hepatic veins (interventional radiological procedure)

Procedure: LVD

ALPPS

EXPERIMENTAL

Associating Liver Partition and Portal vein Ligation for Staged hepatectomy: Patients in this group will undergo surgical ligation of portal vein branch with partial liver transection (surgical procedure)

Procedure: ALPPS

Interventions

PVE PROCEDURE

The procedure is performed under general anesthesia. Ultrasound-guided percutaneous, transhepatic puncture of the branch of the portal vein is performed and a vascular sheath is inserted on the guidewire. A system of catheters and guidewires is inserted through the sheath. Embolization is performed using a homogeneous mixture of Glubran 2 glue and Lipiodol (volume ratio 1:8-1:9). After filling the entire volume of the branch of the portal vein, all catheters, guidewires and the vascular sheaths are removed. A dressing is left over the access site and removed the next day. After treatment the patient is given analgesics and antipyretics if necessary.

Also known as: portal vein embolization

PVE

LVD PROCEDURE

The procedure is performed under general anesthesia. Ultrasound-guided percutaneous, transhepatic puncture of the branch of the portal vein is performed and a vascular sheath is inserted on the guidewire. A system of catheters and guidewires is inserted through the sheath. A similar puncture of the hepatic vein or veins is then performed; sometimes with access via the internal jugular vein. Embolization of the portal branch is performed using a homogeneous mixture of Glubran 2 glue and Lipiodol (volume ratio 1:8-1:9). Embolization of the right hepatic vein or veins begins with the insertion of a vascular plug (Amplatzer) approx. 2 cm from the confluence of the vein(s). The remaining part of the hepatic vein(s) is then filled with a homogeneous mixture of histacryl glue and Lipiodol (volume ratio 1:1). A dressing is left over the access site and removed the next day; patient is given analgesics and antipyretics if necessary.

Also known as: liver venous deprivation

LVD

ALPPS PROCEDURE

The ALPPS procedure will be performed in the operating theatre, under general anesthesia, preferably using a minimally invasive (laparoscopic) technique. The procedure consists of surgical ligation or clipping of the branch of the portal vein with a vascular clip and in partial transection of the parenchyma at the plane of the future resection planned in the second stage (partial transection, approx. 75% of the transection plane).

Also known as: Associating Liver Partition and Portal vein Ligation for Staged hepatectomy

ALPPS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>= 18 years
• patients qualified for liver resection
• future remnant liver \<30% of standard liver volume
• written informed consent

You may not qualify if:

• liver cirrhosis
• pregnancy
• poor general health status or comorbidities excluding general anesthesia or hepatic resection
• contraindications to iodine contrast agents

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Medical Research Agency, Poland: collaborator

Study Sites (1)

Second Department of Clinical Radiology

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Karolina Grąt, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolina Grąt, PhD

CONTACT

+48225992300; karolina.grat@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The Investigator performing statistical analysis will blinded to which study group the patient was assigned to. The patient will not be aware which of the two radiological methods (PVE or LVD) was performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, interventional randomized study. Patients will be randomly assigned to three groups in a 12:71:71 ratio: PVE, LVD and ALPPS groups, respectively. Randomization will be performed directly after recruitment.

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 22, 2023
• Study Start: August 28, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)