Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)
NCT ID: NCT02942238
Last Updated: 2016-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
582 participants
INTERVENTIONAL
2017-01-31
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Complete Mesocolic Excision
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.
CME
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)
D3 lymph node dissection
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.
D3
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
Interventions
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CME
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)
D3
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
Eligibility Criteria
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Inclusion Criteria
2. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
3. Localization diagnosis: the tumor located between the cecum and the right 1/3 of transverse colon;
4. 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.
5. Informed consent
Exclusion Criteria
2. 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;
3. History of any other malignant tumor in recent 5 years;
4. Patients need emergency operation;
5. Not suitable for laparoscopic surgery;
6. Women during Pregnancy or breast feeding period;
7. Informed consent refusal
18 Years
75 Years
ALL
No
Sponsors
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
RenJi Hospital
OTHER
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Fudan University
OTHER
Ruijin Hospital
OTHER
Responsible Party
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Minhua Zheng
professor
Principal Investigators
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Minhua Zheng, PhD
Role: STUDY_DIRECTOR
Ruijin Hospital
Central Contacts
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References
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Ostenfeld EB, Erichsen R, Iversen LH, Gandrup P, Norgaard M, Jacobsen J. Survival of patients with colon and rectal cancer in central and northern Denmark, 1998-2009. Clin Epidemiol. 2011;3 Suppl 1(Suppl 1):27-34. doi: 10.2147/CLEP.S20617. Epub 2011 Jul 21.
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.
Kitano S, Inomata M, Sato A, Yoshimura K, Moriya Y; Japan Clinical Oncology Group Study. Randomized controlled trial to evaluate laparoscopic surgery for colorectal cancer: Japan Clinical Oncology Group Study JCOG 0404. Jpn J Clin Oncol. 2005 Aug;35(8):475-7. doi: 10.1093/jjco/hyi124. Epub 2005 Jul 8.
Guillou PJ, Quirke P, Thorpe H, Walker J, Jayne DG, Smith AM, Heath RM, Brown JM; MRC CLASICC trial group. Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet. 2005 May 14-20;365(9472):1718-26. doi: 10.1016/S0140-6736(05)66545-2.
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.
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.
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.
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.
Eiholm S, Ovesen H. Total mesocolic excision versus traditional resection in right-sided colon cancer - method and increased lymph node harvest. Dan Med Bull. 2010 Dec;57(12):A4224.
Other Identifiers
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Ruijin-0002
Identifier Type: -
Identifier Source: org_study_id