- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02584985
Evaluate Efficacy, Morbidity and Functional Outcome of Endoscopic TranAnal Proctectomy vs Standard Transabdominal Laparoscopic Proctectomy for Rectal Cancer (ETAP)
A Multicentric Randomised Trial to Evaluate Efficacy, Morbidity and Functional Outcome of Endoscopic TranAnal Proctectomy Versus Standard Transabdominal Laparoscopic Proctectomy for Low Lying Rectal Cancer (ETAP-GRECCAR 11)
Standard surgical treatment of mid and low rectal cancer is total mesorectal excision (TME). Originally performed by open surgery, TME demonstrated improved local control and reduced urogenital morbidity. Laparoscopic approach has been validated by several randomised controlled trials: laparoscopic approach offers to the patient a better post-operative recovery, a lower risk of wound hernia and comparable oncological results. However, the risk of conversion to open procedure remains significant.
Endoscopic Transanal Proctectomy allows retrograd mesorectal excision, performing the whole pelvic dissection via a specific-moderate cost device. The procedure is then completed by a briefer transabdominal laparoscopic step to mobilise the colon and perform inferior mesenteric vessels ligation, prior to low coloanal anastomosis. The originality of this approach is to perform a surgical dissection via an extra peritoneal route, without peritoneal and abdominal wound trauma. This focuses on new technical improvement in the area of mini-invasive pelviabdominal surgery using natural orifice as surgical access. This approach offer closer and better exposure of pelvic dissection plane and could improve oncological quality and pelvic nerve preservation. It could be profitable to postoperative patient outcome. However rates and type of cancer-recurrences as well as functional results have to be assessed in a controlled study. This technique has shown to be feasible and reproducible through early clinical series. Conversion rates appear to be lower than published rates of laparoscopic approach, markedly inferior to 10%. Compiled rates of morbidity (27.8%), R1 resection* (6%), mesorectum macroscopic integrity (100%) appear to be comparable to laparoscopic approach results. However functional results as well as urologic morbidity have to be evaluated in comparative studies. In a preliminary retrospective comparative (n=72) we founded comparable oncological quality criteria (R1 resection 5.9% vs 10.5% p 0.74, Grade 3 mesorectal integrity 57.5 vs 56.2 p 0.99), lower conversion rate to open procedure (2.9% vs 23.6% p 0.011), shorter in-hospital stay (8 vs 9 days p 0.038). Comparable morbidity rates (Dindo 1-4 27% vs 34% p 0.52) and functional results (Kirwan 1/2 80.3% vs 80.6% p 0.94) were also founded. These data need to be confirmed. To this date, Endoscopic Transanal Proctectomy has been evaluated through preliminary studies including several short series demonstrating the feasibility of the technique and showing low morbidity. For some authors the benefit of transanal approach is significant in difficult cases such as male patient and narrow pelvis. Very recently, two non randomised comparative studies were published with conclusions close to those in our study.
Investigators propose, with the support of the GRECCAR group, to conduct a national, multicenter, open-label randomized study based on oncological non-inferiority (R1 resection rate) for the main objective, comparing Endoscopic Transanal Proctectomy to Standard Transabdominal Laparoscopic Proctectomy, for low lying rectal cancer requiring manual colo-anal anastomosis. There is a clear expected benefit expected for the patients through the ETAP procedure in term of post operative short term outcome, risk of conversion to open procedure, risk of wound hernia.This trial could also show significant advantages in terms of quality of dissection, quality of the specimen, quality of nerve preservation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Cournier Sandra
- Phone Number: 33 (0)4 91 22 37 78
- Email: drci.up@ipc.unicancer.fr
Study Locations
-
-
-
Marseille, France, 13009
- Recruiting
- Institut Paoli-Calmettes
-
Contact:
- COURNIER Sandra
- Phone Number: 33(0) 4 91 22 37 78
- Email: drci.up@ipc.unicancer.fr
-
Principal Investigator:
- LELONG Bernard, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non metastatic stadified T3 rectal adenocarcinoma allowing sphincter-sparing procedure
- Tumor location or local condition justifying manual coloanal anastomosis
- Age >18 years
- Patient eligible for surgery
- Written informed consent
- Affiliation to Social Security System
Exclusion Criteria:
- Tumor stadified T4 with en-bloc resection
- Possible mechanical trans-sutural anastomosis
- Distant metastasis at diagnosis
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
- Patients deprived of liberty or placed under the authority of a tutor
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ETAP : Endoscopic Transanal Proctectomy
Type of laparoscopic approach multiport or singleport. Level of arterial section, extension of colonic mobilization, site for specimen extraction (transanal / transabdominal), type of colonic reconstruction. |
Primary transanal endoscopic approach, secondary transabdominal laparoscopic approach
|
Other: Standard Transabdominal Laparoscopic proctectomy
Primary transanal conventional dissection (sphincter preservation assessment) or not, type of laparoscopic approach multiport or singleport, level of arterial section, extension of colonic mobilization, conditions of mesorectal excision and nerve preservation, site for specimen extraction (transanal / transabdominal) and type of colonic reconstruction.
|
Primary transabdominal laparoscopic approach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
R1 resection rate
Time Frame: from surgery up to 3 years
|
R1 resection rate defined as circumferential resection margin (CRM) ≤ 1 mm, distal or positive margin (and the complete rectal resection meso levels (grade III) as classified by Quirke).
|
from surgery up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Failure rate (conversion to open)
Time Frame: During surgery
|
During surgery
|
Disease-free survival at 3 years
Time Frame: 3 years from surgery
|
3 years from surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: LELONG Bernard, MD, Institut Paoli-Calmettes
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETAP-GRECCAR 11-IPC 2015-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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