Alternative to Two-Stage Hepatectomy

Two-stage hepatectomy with or without portal vein embolization allows to treat multiple bilobar metastases expanding surgical indications for these patients. However, it has some related drawbacks: two operations are needed, and some patients do not complete the treatment strategy for disease progression. Using experience gained from our ultrasound guided resection policy we explored the safety and effectiveness of one-stage surgical procedures in patients otherwise recommended for the two-stage approach.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Metastases Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Clinico Humanitas - Irccs

Rozzano - Milano, 20089, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients presenting with resectable colorectal cancer liver metastases (CLM)
4 or more lesions
Bilobar involvement of the liver
Contact or close adjacency (less than 0.5 cm) of at least one CLM with major intrahepatic vascular structures (1st or 2nd order portal branches and/or hepatic vein at caval confluence).

Exclusion criteria

Patients with 3 or less resectable CLM
Patients with 4 or more resectable CLM but nor bilobar
Patients with 4 or more bilobar resectable CLM without any lesion presenting condition of point 4 of the inclusion criteria

Treatment and study plan

One-stage ultrasound guided hepatectomy

Procedure

Surgical strategy was based on tumor-vessel relationship at intraoperative ultrasonography (IOUS)and on findings at color-Doppler IOUS.

Primary outcomes

The primary outcome was the safety of the procedure. To this purpose we studied morbidity, mortality, amount of blood loss, rate of blood transfusions, and postoperative trend of liver function tests.

Time frame: 30-day and 90-day postoperatively

Secondary outcomes

The secondary outcome measure was the reliability of the procedure from an oncological standpoint. For this purpose we studied the rate of true local recurrence (cut-edge) after a minimum follow-up of 6 months.

Time frame: Minimum Follow-up of 6 months

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Collaborators

Fondazione Humanitas per la Ricerca

Registry information

Official study title

One-Stage Ultrasound-Guided Hepatectomy for Multiple Bilobar Colorectal Metastases: a Feasible and Effective Alternative to Two-Stage Hepatectomy

Important dates

Study start: 2001
Primary completion: 2007
Study completion: 2007
First posted: Jan 7, 2008
Registry last updated: Jan 8, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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