Status:

COMPLETED

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

Lead Sponsor:

Fudan University

Conditions:

Rectal Neoplasm With Metastasis to the Liver

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

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 an...

Detailed Description

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) sh...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2022

Estimated Enrollment :

180 Patients enrolled

Trial Details

Trial ID

NCT00677586

Start Date

July 1 2010

End Date

July 1 2022

Last Update

July 7 2022

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