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OpenTrials
Completed

NCT Number: NCT05462470

Impact of Surgical Management for Relapse After Conversion Hepatectomy for Initially Unresectable Colorectal Liver Metastasis

For patients with initially unresectable colorectal liver metastasis (IU-CRLM) receiving effective conversion therapy, disease relapse after conversion hepatectomy is common due to the extensive tumor load. Yet, few studies have focused on the assessment and management of relapse after conversion hepatectomy for IU-CRLM. This study aimed to investigate the impact of surgical management for relapse after conversion hepatectomy in IU-CRLM.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • initially unresectable colorectal liver metastasis (IU-CRLM)
  • received conversion therapy
  • underwent conversion hepatectomy

Exclusion criteria

  • the histologic type of CRLM was not called adenocarcinoma
  • uncontrollable extrahepatic metastases, such as peritoneal, bone, brain metastasis
  • history of previous hepatectomy
  • the primary tumor was not resected or palliative resection
  • R1 or R2 liver resection

Treatment and study plan

Repeat Liver Surgery

Procedure

repeat liver surgery included not only hepatectomy, but also ablative treatment, including radiofrequency ablation (RFA) and microwave ablation (MWA)

Non-Repeat Liver Surgery

Procedure

Systemic palliative chemotherapy

Primary outcomes

  1. overall survival

    Time frame: 5 years

    Overall survival after the first resection of liver metastatic lesions

Secondary outcomes

  1. first relapse free survival

    Time frame: 5 years

    relapse free survival after the first resection of liver metastatic lesions

  2. second relapse free survival

    Time frame: 5 years

    relapse free survival after the repeat liver surgery of liver metastatic lesions

  3. Severe complication rate after resection of primary and metastatic lesions

    Time frame: 30 days after surgery

    Grade of III-V complication rate according to Clavien-Dindo

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Important dates

Study start
2008
Primary completion
2022
Study completion
2022
First posted
Jul 18, 2022
Registry last updated
Jul 19, 2022

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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