- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03329495
Laparoscopic Right Hemicoloectomy for Right Colon Cancer With a Medial-to-lateral Approach Orientated by SMA or SMV
A Randomized Controlled Clinical Trial to Investigate the Effect of SMA- or SMV- Orientated Laparoscopic Right Hemicoloectomy for Right Colon Cancer With a Medial-to-lateral Approach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In 2008, Germany scholar W. Hohenberger proposed the idea of complete mesocolic excision (CME) and central vascular ligation (CVL) for the standardization of colonic cancer surgery. This concept has been widely recognized and accepted. This radical operation attempts to remove the mesocolon intactly by careful dissection along the embryologic tissue planes and transection of the supplying vessels at their origin. For right-sided colon cancer, this approach involves division of the vessels at their origin from the superior mesenteric artery (SMA) and superior mesenteric vein (SMV). In our opinion, full exposure of the SMA and SMV is necessary to make sure that the origin of the colonic arteries being truly exposed and tied centrally at their origin and a maximal harvest of the regional lymphnodes. For locally advanced colon cancer, SMA- orientated surgery may be more meaningful to recerve a radical lymphadenectomy and bring benefit for their survival. However, in the traditional practise, the lymph node dissection is orientated by SMV and SMA is not exposed, tissue around SMA is left behind.
In this study, eligible patients with right colon cancer will be randomly allocated to receive either SMA- or SMV- orientated laparoscopic right hemicoloectomy. 100 patients will be enrolled in each group. In SMV- orientated surgery group, SMA is not exposed and the left boundary of resection is the left side of SMV. In SMA- orientated surgery group, the left boundary of resection is the left side of SMA and SMA is exposed.Artery sheath is not necessarily to be opened. Postoperative pathology will be analyzed with the number of lymph nodes retrieved. Postoperative recovery process and long term survival will be followed.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Jiangsu
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Nanjing, Jiangsu, China, 210029
- Jiangsu Province Hospital
-
Contact:
- Yueming Sun
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients suitable for curative surgery between 18 - 85 years old;
- American Society of Anesthesiologists(ASA) grade I-III;
- Preoperative pathological diagnosis of adenocarcinoma;
- Tumor located at the right colon;
- Informed consent;
- No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
Exclusion Criteria:
- Pregnant patient;
- History of psychiatric disease;
- Use of systemic steroids;
- Simultaneous multiple primary colorectal cancer;
Preoperative enhanced CT scan of chest, abdominal and pelvic cavity shows:
- Tumor involves the surrounding organs and combined organ resection needed to be done;
- distant metastasis;
- unable to perform R0 resection;
- History of any other malignant tumor in recent 5 years;
- Patients need emergency operation: mechanic ileus, perforation.
- Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
- Conversion from laparoscopic surgery to laparotomy;
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 |
---|---|
ACTIVE_COMPARATOR: SMA-orientated right hemicoloectomy
|
Laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach orientated by SMA.
The left boundary of resection is the left side of SMA, and artery sheath is not necessarily being opened.
|
EXPERIMENTAL: SMV-orientated right hemicoloectomy
|
Laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach orientated by SMV.
The left boundary of resection is the left side of SMV, and SMA is not exposed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of lymph nodes retrieved
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
operative time
Time Frame: 1 day
|
1 day
|
|
overall survival
Time Frame: 3 years
|
3 years
|
|
disease-free survival
Time Frame: 3 years
|
3 years
|
|
recurrence-free survival
Time Frame: 3 years
|
3 years
|
|
early complication rate
Time Frame: 30 days
|
Early complication is defined as a complication that occurred between the finish of the surgery and postoperative day.
Complications includes anastomotic leakage, anastomotic bleeding, chyle leakage, wound infection, pulmonary embolism, myocardial infarction et al.The Clavien-Dindo Classification of Surgical Complications will be applied to access the degree of severity of postoperative complications.
|
30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Fumin Zhang, Professor, Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
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
- CRSYM201710
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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