Back to resultsStandardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)
Primary Purpose
Overall Survival, Postoperative Complications, Metastasis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CME
D3
Sponsored by
About this trial
This is an interventional treatment trial for Overall Survival focused on measuring CME, Right hemi Colon cancer, D3, laparoscopy
Eligibility Criteria
Inclusion Criteria:
- Patients suitable for curative surgery 18-75years old
- Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
- Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon;
- Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T stage 1-4 and N stage 0-2; there is no distant metastasis.
- Informed consent
Exclusion Criteria:
- Simultaneous or simultaneous multiple primary colorectal cancer;
- Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection;
- History of any other malignant tumor in recent 5 years;
- Patients need emergency operation;
- Not suitable for laparoscopic surgery;
- Women during Pregnancy or breast feeding period;
- Informed consent refusal
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Complete Mesocolic Excision
D3 lymph node dissection
Arm Description
the group underwent laparoscopic right hemicolectomy with CME. In complete mesocolic excision group (CME), the dissecting extent includes the lymphatic and fat tissues surrounding the root of ascending mesocolon, which situated on the surface of superior mesenteric vein, and the root of right half of transverse mesocolon, which situated on the surface of pancreas neck.
the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 lymph node dissection group(D3), the lymph node dissection is based on ligating the supplying vessels close to the right-side of superior mesenteric vein and clean up the surrounding lymph node and adipose tissue. No.6 lymph node should be dissected in this group.
Outcomes
Primary Outcome Measures
Disease-free survival
Secondary Outcome Measures
The rate of postoperative complications and mortality
3 years overall survival
The rate of local and distant recurrence
The accuracy of preoperative staging with CT
Full Information
NCT ID
NCT02942238
First Posted
October 20, 2016
Last Updated
December 20, 2016
Sponsor
Ruijin Hospital
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT02942238
Brief Title
Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)
Official Title
Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, RenJi Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether extended lymphadenectomy (CME) could improve disease-free survival in patients with right colon cancer, compared with D3 radical operation in laparoscopic colectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overall Survival, Postoperative Complications, Metastasis, Stage, Colon Cancer
Keywords
CME, Right hemi Colon cancer, D3, laparoscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
582 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Complete Mesocolic Excision
Arm Type
Experimental
Arm Description
the group underwent laparoscopic right hemicolectomy with CME. In complete mesocolic excision group (CME), the dissecting extent includes the lymphatic and fat tissues surrounding the root of ascending mesocolon, which situated on the surface of superior mesenteric vein, and the root of right half of transverse mesocolon, which situated on the surface of pancreas neck.
Arm Title
D3 lymph node dissection
Arm Type
Active Comparator
Arm Description
the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 lymph node dissection group(D3), the lymph node dissection is based on ligating the supplying vessels close to the right-side of superior mesenteric vein and clean up the surrounding lymph node and adipose tissue. No.6 lymph node should be dissected in this group.
Intervention Type
Procedure
Intervention Name(s)
CME
Intervention Description
the group underwent laparoscopic right hemicolectomy with CME. In CME group, in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodes should be entirely removed.
Intervention: Procedure: Complete mesocolic excision (CME)
Intervention Type
Procedure
Intervention Name(s)
D3
Intervention Description
the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 group, the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes,including No.6 lymph node, which along the feeding vessels.
Intervention: Procedure: D3 radical operation
Primary Outcome Measure Information:
Title
Disease-free survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
The rate of postoperative complications and mortality
Time Frame
30 days
Title
3 years overall survival
Time Frame
3 years
Title
The rate of local and distant recurrence
Time Frame
3 years
Title
The accuracy of preoperative staging with CT
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients suitable for curative surgery 18-75years old
Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon;
Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T stage 1-4 and N stage 0-2; there is no distant metastasis.
Informed consent
Exclusion Criteria:
Simultaneous or simultaneous multiple primary colorectal cancer;
Preoperative imaging examination results show: (1) Tumor involves the surrounding organs and combined organ resection need to be done; (2)distant metastasis; (3)unable to perform R0 resection;
History of any other malignant tumor in recent 5 years;
Patients need emergency operation;
Not suitable for laparoscopic surgery;
Women during Pregnancy or breast feeding period;
Informed consent refusal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minhua Zheng, PhD
Phone
+86-13564119545
Email
zmhtiger@yeah.net
First Name & Middle Initial & Last Name or Official Title & Degree
Hiju Hong, PhD Student
Phone
+86-13564119545
Email
jing12722@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minhua Zheng, PhD
Organizational Affiliation
Ruijin Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21814467
Citation
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Results Reference
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PubMed Identifier
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Citation
Laparoscopically assisted colectomy is as safe and effective as open colectomy in people with colon cancer Abstracted from: Nelson H, Sargent D, Wieand HS, et al; for the Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med 2004; 350: 2050-2059. Cancer Treat Rev. 2004 Dec;30(8):707-9. doi: 10.1016/j.ctrv.2004.09.001. No abstract available.
Results Reference
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PubMed Identifier
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Citation
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Citation
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Results Reference
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PubMed Identifier
19755046
Citation
Engstrom PF, Arnoletti JP, Benson AB 3rd, Chen YJ, Choti MA, Cooper HS, Covey A, Dilawari RA, Early DS, Enzinger PC, Fakih MG, Fleshman J Jr, Fuchs C, Grem JL, Kiel K, Knol JA, Leong LA, Lin E, Mulcahy MF, Rao S, Ryan DP, Saltz L, Shibata D, Skibber JM, Sofocleous C, Thomas J, Venook AP, Willett C; National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: colon cancer. J Natl Compr Canc Netw. 2009 Sep;7(8):778-831. doi: 10.6004/jnccn.2009.0056. No abstract available.
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PubMed Identifier
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Citation
West NP, Kobayashi H, Takahashi K, Perrakis A, Weber K, Hohenberger W, Sugihara K, Quirke P. Understanding optimal colonic cancer surgery: comparison of Japanese D3 resection and European complete mesocolic excision with central vascular ligation. J Clin Oncol. 2012 May 20;30(15):1763-9. doi: 10.1200/JCO.2011.38.3992. Epub 2012 Apr 2.
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Citation
Kobayashi H, West NP, Takahashi K, Perrakis A, Weber K, Hohenberger W, Quirke P, Sugihara K. Quality of surgery for stage III colon cancer: comparison between England, Germany, and Japan. Ann Surg Oncol. 2014 Jun;21 Suppl 3:S398-404. doi: 10.1245/s10434-014-3578-9. Epub 2014 Feb 25.
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Citation
Bertelsen CA, Neuenschwander AU, Jansen JE, Wilhelmsen M, Kirkegaard-Klitbo A, Tenma JR, Bols B, Ingeholm P, Rasmussen LA, Jepsen LV, Iversen ER, Kristensen B, Gogenur I; Danish Colorectal Cancer Group. Disease-free survival after complete mesocolic excision compared with conventional colon cancer surgery: a retrospective, population-based study. Lancet Oncol. 2015 Feb;16(2):161-8. doi: 10.1016/S1470-2045(14)71168-4. Epub 2014 Dec 31.
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Citation
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Results Reference
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Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)
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