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

NCT ID: NCT03168230

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-02-27
• Study Completion Date: 2016-05-21

Brief 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.

Conditions

Liver Cancer; Liver Metastases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PVE

Patients who required PVE prior to the attempt of liver resection.

Portal vein embolization (PVE)

Intervention Type: PROCEDURE

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

No-PVE

Patients who received upfront surgery (no PVE prior to the intervention)

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• Individuals requiring a two-stage hepatectomy.
• Patient who had previous hepatectomy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yves Collin, MD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

References

Collin Y, Pare A, Belblidia A, Letourneau R, Plasse M, Dagenais M, Turcotte S, Martel G, Roy A, Lapointe R, Vandenbroucke-Menu F. Portal vein embolization does not affect the long-term survival and risk of cancer recurrence among colorectal liver metastases patients: A prospective cohort study. Int J Surg. 2019 Jan;61:42-47. doi: 10.1016/j.ijsu.2018.11.029. Epub 2018 Dec 8.

Reference Type: DERIVED

PMID: 30537548 (View on PubMed)

Other Identifiers

12.106

Identifier Type: -

Identifier Source: org_study_id