Clinical trial NCT02942238: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Overall Survival
Postoperative Complications
Metastasis
Stage, Colon Cancer
Keywords: CME
Right hemi Colon cancer
D3
laparoscopy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: RenJi Hospital
name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Fudan University
First posted: 2016-10-24
Enrollment: 582
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival
timeFrame: 3 years
Secondary outcomes:
measure: The rate of postoperative complications and mortality
timeFrame: 30 days
measure: 3 years overall survival
timeFrame: 3 years
measure: The rate of local and distant recurrence
timeFrame: 3 years
measure: The accuracy of preoperative staging with CT
timeFrame: 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Ruijin Hospital
name: Minhua Zheng, PhD
role: STUDY_DIRECTOR
References:
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