Impact of PVE on Patient's Long-term Survival, Complications and Cancer Recurrence.

Liver Cancer Clinical Trial

Official title:

Impact of Portal Vein Embolization on Patient's Long-term Survival, Complications and Cancer Recurrence.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03168230
• Other study ID #: 12.106
• Status: Completed
• Phase: N/A
• First received: May 24, 2017
• Last updated: May 24, 2017
• Start date: February 27, 2004
• Est. completion date: May 21, 2016

Study information

• Verified date: May 2017
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

For patients with colorectal liver metastasis (CLM), the prospect of long-term survival relies on liver resection. Wistfully, more than 75 % of patients with CLM are initially unresectable, due to an insufficient future liver remnant (FLR) volume

In order to increase FLR volume, most patients will first receive chemotherapy to reduce the tumor load (downsizing).

When chemotherapy is insufficient to provide an adequate postoperative FLR, portal vein embolization (PVE) can be performed. About 50-70 % of patients undergoing PVE obtain a sufficient liver hypertrophy to allow liver resection.

While PVE is recognised for its efficacy to induce liver hypertrophy, some studies expressed substantial concerns regarding the potential adverse effect of this intervention on pre-resection tumor progression, increased risk of cancer recurrence following resection and reduced overall survival following resection

Those studies suggested that the need to perform PVE should be assessed thoroughly for each patient and that chemotherapy should be maintained during the whole hypertrophy process in order to contain the potential adverse effect of PVE on tumor progression.

Other studies found no significant association between PVE and negative oncological outcomes.

As mentioned in almost every study cited above, more data is needed to provide a clearer vision regarding the impact of PVE on tumor progression and cancer recurrence following liver resection.

The aim of this study is to compare the overall and disease-free survival of PVE-requiring patients to the ones who underwent upfront surgery (NoPVE).

As a secondary objective, the impact of several covariates (related to surgery, patient's condition and disease stage) on survival and cancer recurrence will be tested.

Our hypothesis are that 1) PVE might be associated with a lower overall survival and a higher risk of cancer recurrence in univariate analysis but 2) this association will not remain significant when other covariates are included in the proportional COX hazard models.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 21, 2016
• Est. primary completion date: May 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Patients with the following inclusion criterias were approached:

• Diagnosis of colorectal liver metastasis (CLM).

• Scheduled for a one-stage right/extended right hepatectomy in Centre Hospitalier Universitaire de Montréal (CHUS) - Hospital Saint-Luc.

Exclusion Criterias:

• Individuals requiring a two-stage hepatectomy.

• Patient who had previous hepatectomy.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Metastases
• Liver Neoplasms
• Recurrence

Intervention

Procedure:
• Portal vein embolization (PVE)
Portal vein embolization (PVE) is a procedure that induces regrowth on one side of the liver in advance of a planned hepatic resection on the other side. The procedure is frequently used in primary liver cancer (hepatocellular carcinoma) and colorectal liver metastases. An interventional radiologist will place a needle percutaneously (through the skin) into the liver and identify the blood vessel on the side where the largest part of the tumor is being supplied. Tiny microspheres are then infused into the portal vein which supplies blood to the area, embolizing it by cutting off its blood supply. This blockade of the blood supply induces the other side of the liver to regrow. After several weeks, the non-embolized side has grown enough so that surgery is now a viable option. Source of this information : http://general.surgery.ucsf.edu/conditions--procedures/portal-vein-embolization-(pve).aspx

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		5 years
Primary	Disease-free survival		5 years