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

Not Applicable

• Conditions: Postoperative Complications; Stage, Colon Cancer; Overall Survival; Metastasis
• Interventions: Procedure: D3; Procedure: CME

• Registration Number: NCT02942238
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-20
• Study First Posted: 2016-10-24
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-21
• Study Start: 2017-01
• Primary Completion: 2020-01
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 582

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D3 lymph node dissection	D3	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.
Complete Mesocolic Excision	CME	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.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
3 years overall survival	3 years
The rate of local and distant recurrence	3 years
The accuracy of preoperative staging with CT	14 days
The rate of postoperative complications and mortality	30 days