Status:
UNKNOWN
Intersphincteric Resection With or Without Intraoperative Radiation in Rectal Cancer
Lead Sponsor:
Second Hospital of Jilin University
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study was to research on the safety and feasibility of ISR combined with low energy X ray intra-operative radiotherapy for the patients with local advanced rectal cancer.
Detailed Description
Inter-sphincteric resection (ISR) has become an increasingly popular optional surgical tool for the treatment of very low rectal cancer. Nowadays, preoperative criteria for Lap ISR were the patients w...
Eligibility Criteria
Inclusion
- those whom were preoperatively assessed to be in clinical stageT3 or has lymphatic metastasis by MRI or ultrasonic endoscopy;
- the lower edge of the tumor is away from the anal edge by less than 5 cm, or away from the dentate line by less than 3cm;
- in intra-operative separation, the lower edge of the tumor is below the plane of the levator ani muscle or the tumor is hard to separate;
- those in T4 stage and could be radically resected by intra-operative surgeon assessment;
- adequate preoperative sphincter function and continence; (vi)local spread restricted to the rectal wall or the IAS.
- absence of distant metastases.
Exclusion
- clinical T4 tumors based on the Union for International Cancer Control UICC TNM classification (7th edition):
- infiltrating gross appearance of the tumors;
- poorly differentiated adenocarcinoma by biopsy specimens;
- a degree of preoperative incontinence.
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03393234
Start Date
June 1 2017
End Date
January 1 2022
Last Update
January 8 2018
Active Locations (1)
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1
The Second Hospital of Jilin University
Changchun, Jilin, China, 130041