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NCT Number: NCT00677586

Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis

The purpose of this study is to investigate the safety and efficacy of simultaneous liver resections compared to staged hepatectomies of rectal cancer with liver metastasis and to compare the short and long-term survival between the two groups.

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Key information

Conditions

Rectal Neoplasm With Metastasis to the Liver Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The optimal surgical strategy for treatment of patients with resectable synchronous rectal liver metastases remains controversial. To answer whether synchronous rectal cancer liver metastases (SLM) should be resected simultaneously with primary cancer or should be delayed, We conducted a randomized, controlled trial to compare the safety and efficacy of simultaneous versus delayed resection of the rectum and liver. Patients with rectal cancer and resectable SLM were randomly assigned to either simultaneous or delayed resection of the metastases. The primary outcome was the rate of major complications (Clavien-Dindo grade≥III) within 30 days following surgery. Secondary outcomes included disease-free and overall survival. A consecutive patients of rectal cancer with liver metastasis from ZhongShan hospital, Fudan university were enrolled and randomly assigned to simultaneous liver resections and staged hepatectomies. Post-operative complications, peri-operative mortality, long-term survival were compared.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age>=18 and <= 75 years
  • resectable primary rectal tumor
  • remnant liver volume >= 60%
  • without other organ metastasis or peritoneum metastasis
  • without contradiction of cardiac and pulmonary diseases
  • American Society of Anesthesiologists (ASA) class I - II
  • Histologically proved rectal adenocarcinoma

Exclusion criteria

  • age > 75 years
  • unresectable primary rectal tumor
  • remnant liver volume < 60%
  • with other organ metastasis or peritoneum metastasis
  • with contradiction of cardiac and pulmonary diseases
  • Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy
  • Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
  • Multiple colorectal tumors or other schedules needing for synchronous colon surgery
  • Co-existent inflammatory bowel disease
  • Pregnancy or lactation
  • Patients received treatment other than preoperative radio- or chemoradiotherapy

Treatment and study plan

simultaneous resection of liver metastasis and the rectal primary tumor

Procedure

simultaneous resection of liver metastasis and the rectal primary tumor

staged resection of liver metastasis and the rectal primary tumor

Procedure

Patients received resection of the rectal tumor. 1 months later received resection of liver metastasis

Primary outcomes

  1. 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

Secondary outcomes

  1. Disease free survival

    Time frame: 3 years

    Disease free survival after the last resection of primary and metastatic lesions

  2. Overall survival

    Time frame: 3 years

    Overall survival after the last resection of primary and metastatic lesions

  3. Post-operative mortality

    Time frame: 90 days after surgery

    any death occured within 90 days after the last resection of primary and metastatic lesions

  4. Cost of hospitalization

    Time frame: 2 months

    any cost during the resection of primary and metastatic lesions

  5. Complication rate after resection of primary and metastatic lesions

    Time frame: 30 days after surgery

    All grade of complication rate according to Clavien-Dindo

  6. Postoperative hospital stay

    Time frame: 30 days after surgery

    The postoperative hospital stay is defined as the number of date from the first day after operation to discharge

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis: A Randomized Controlled Trial

Important dates

Study start
2010
Primary completion
2020
Study completion
2022
First posted
May 14, 2008
Registry last updated
Jul 7, 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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