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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Postoperative Complications; Stage, Colon Cancer; Metastasis; Overall Survival

Treatments: Procedure: CME; Procedure: D3

Study type: Interventional

Funder types: Other

Identifiers

NCT02942238

Ruijin-0002

Details and patient eligibility

About

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.

Enrollment: 582 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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582 participants in 2 patient groups

Complete Mesocolic Excision

Experimental group

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.

Treatment:

Procedure: CME

D3 lymph node dissection

Active Comparator group

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.

Treatment:

Procedure: D3