Rectal Neoplasm With Metastasis to the Liver
Conditions
Keywords
rectal neoplasms, liver metastasis, surgery, simultaneous resection, staged resection
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 and long-term survival between the two groups.
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.
Interventions
PROCEDUREsimultaneous resection of liver metastasis and the rectal primary tumor
simultaneous resection of liver metastasis and the rectal primary tumor
PROCEDUREstaged resection of liver metastasis and the rectal primary tumor
Patients received resection of the rectal tumor. 1 months later received resection of liver metastasis
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Rectal cancer patients with synchronous resectable liver metastasis were randomized to simultaneous resection of primary and metastatic lesions or staged resection
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe complication rate after resection of primary and metastatic lesions | 30 days after surgery | Grade of III-V complication rate according to Clavien-Dindo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 years | Overall survival after the last resection of primary and metastatic lesions |
| Post-operative mortality | 90 days after surgery | any death occured within 90 days after the last resection of primary and metastatic lesions |
| Disease free survival | 3 years | Disease free survival after the last resection of primary and metastatic lesions |
| Complication rate after resection of primary and metastatic lesions | 30 days after surgery | All grade of complication rate according to Clavien-Dindo |
| Postoperative hospital stay | 30 days after surgery | The postoperative hospital stay is defined as the number of date from the first day after operation to discharge |
| Cost of hospitalization | 2 months | any cost during the resection of primary and metastatic lesions |
Outcome results
None listed