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NCT Number: NCT03168230

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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 criteria

s:

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

Treatment and study plan

Portal vein embolization (PVE)

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

Primary outcomes

  1. Overall survival

    Time frame: 5 years

  2. Disease-free survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2016
Study completion
2016
First posted
May 30, 2017
Registry last updated
May 30, 2017

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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