Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)

Postoperative Complications Clinical Trial

Official title:

Standardization of Laparoscopic Surgery for Right Hemi Colon Cancer (SLRC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02942238
• Other study ID #: Ruijin-0002
• Status: Not yet recruiting
• Phase: N/A
• First received: October 20, 2016
• Last updated: December 20, 2016
• Start date: January 2017
• Est. completion date: December 2022

Study information

• Verified date: December 2016
• Source: Ruijin Hospital
• Contact: Minhua Zheng, PhD
• Phone: +86-13564119545
• Email: zmhtiger[@]yeah.net
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 582
• Est. completion date: December 2022
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients suitable for curative surgery 18-75years old

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:

1. Simultaneous or simultaneous multiple primary colorectal cancer;

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms
• Metastasis
• Overall Survival
• Postoperative Complications
• Stage, Colon Cancer

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Ruijin Hospital	Fudan University, RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

References & Publications (9)

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, Gögenur I; Danish Colorectal Cancer Group.. Disease-free survival after complete mesocolic exci — View Citation

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. — View 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, S — View Citation

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, rand — View Citation

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):4 — View 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/s10434-0 — View 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 — View Citation

Ostenfeld EB, Erichsen R, Iversen LH, Gandrup P, Nørgaard M, Jacobsen J. Survival of patients with colon and rectal cancer in central and northern Denmark, 1998-2009. Clin Epidemiol. 2011;3 Suppl 1:27-34. doi: 10.2147/CLEP.S20617. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival		3 years	No
Secondary	The rate of postoperative complications and mortality		30 days	No
Secondary	3 years overall survival		3 years	No
Secondary	The rate of local and distant recurrence		3 years	No
Secondary	The accuracy of preoperative staging with CT		14 days	No