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

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

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.

Study Overview

• Status: Completed
• Conditions: Rectal Neoplasm With Metastasis to the Liver
• Intervention / Treatment: Procedure: simultaneous resection of liver metastasis and the rectal primary tumor; Procedure: staged resection of liver metastasis and the rectal primary tumor

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) 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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; simultaneous resection of liver metastasis and the rectal primary tumor	Procedure: simultaneous resection of liver metastasis and the rectal primary tumor; simultaneous resection of liver metastasis and the rectal primary tumor
Active Comparator: 2; staged resection of the liver metastasis and the rectal primary tumor	Procedure: staged resection of liver metastasis and the rectal primary tumor; Patients received resection of the rectal tumor. 1 months later received resection of liver metastasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe complication rate after resection of primary and metastatic lesions	Grade of III-V complication rate according to Clavien-Dindo	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	Disease free survival after the last resection of primary and metastatic lesions	3 years
Overall survival	Overall survival after the last resection of primary and metastatic lesions	3 years
Post-operative mortality	any death occured within 90 days after the last resection of primary and metastatic lesions	90 days after surgery
Cost of hospitalization	any cost during the resection of primary and metastatic lesions	2 months
Complication rate after resection of primary and metastatic lesions	All grade of complication rate according to Clavien-Dindo	30 days after surgery
Postoperative hospital stay	The postoperative hospital stay is defined as the number of date from the first day after operation to discharge	30 days after surgery

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2010
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: May 12, 2008
• First Submitted That Met QC Criteria: May 13, 2008
• First Posted (Estimate): May 14, 2008

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 2, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: surgery; liver metastasis; simultaneous resection; rectal neoplasms; staged resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Rectal Neoplasms; Hematinics; Liver Extracts
• Other Study ID Numbers: RESONANCE