Prospective Study of Oncologic Outcomes After Laparoscopic Modified Complete Mesocolic Excision for Non-metastatic Right Colon Cancer [PIONEER Study]

• Conditions: Adenocarcinoma of the Colon
• Interventions: Procedure: Laparoscopic modified complete mesocolic excision

• Registration Number: NCT03992599
• Lead Sponsor: Yonsei University

Brief Summary

This study is a multi-institutional, prospective, observational study evaluation oncologic outcomes of laparoscopic modified complete mesocolic excision (mCME) on right-sided colon cancer.

The primary outcome of this study is 3 year disease-free survival. Secondary outcome measures include 3 year overall survival, incidence of surgical complications, completeness of mCME, and distribution of metastatic lymph nodes.

Detailed Description

The present study aims to evaluate the oncological outcomes of laparoscopic mCME on right-sided colon cancer. The right side of the colon was defined as the colon from cecum up to the proximal half of the transverse colon. The number of patients needs to get a 90% power is 250. Patients will be enrolled at five leading centers in South Korea. A complete information leaflet will give to the patients during the first consultation, which will correspond to the enrollment day. The preoperative, intraoperative, and postoperative period will be in complete accordance with the usual care of the center. The baseline demographics and conditions, as well as the perioperative items and the postoperative occurrences, will be recorded through a prior designed case report form. The follow-up encompasses 13 postoperative consultations: 1month, 3 months, after that every 3 months until 36 months.

The primary outcome of this study is 3-year disease-free survival. Secondary outcome measures include 3-year overall survival, the incidence of surgical complications, completeness of mCME, and distribution of metastatic lymph nodes. Review of resected surgical specimens and the operative field after completion of lymph node dissection will be done based on photographs to assess the quality if surgery.

Study Timeline

• Study First Submitted: 2019-06-18
• Study First Submitted QC: 2019-06-18
• Study First Posted: 2019-06-20
• Study Start: 2019-08-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-01
• Last Update Posted: 2019-10-04
• Primary Completion: 2024-07
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• 1. Qualitative diagnosis: a pathological diagnosis of adenocarcinoma; the tumor located between the cecum and the right 1/2 of transverse colon
• 2. Patients suitable for curative surgery older than 19 years old
• 3. ASA grade I-III
• 4. Patients without preoperative treatment
• 5. Informed consent

Exclusion Criteria

• 1. Informed consent refusal
• 2. Patients who need emergency operation; such as perforation, malignant colonic obstruction
• 3. Preoperative imaging examination results show: distant metastasis
• 4. Hereditary colon cancer
• 5. History of any other malignant tumor in recent 5 years, except for cervical carcinoma in situ which has been cured, basal cell carcinoma or squamous cell carcinoma of skin;
• 6. Simultaneous or simultaneous multiple primary colorectal cancer
• 7. Women during Pregnancy or breast feeding period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic modified central mesocolic excision	Laparoscopic modified complete mesocolic excision	Patients receiving laparoscopic colectomy with the concept of modified complete mesocolic excision for right-sided colon cancer

Primary Outcome Measures

Name	Time	Method
3 year disease-free survival (DFS)	DFS will be measured up to three years after surgery, and the last visit is 14th visit after index surgery.	The 3 year disease-free survival is defined as the time from surgery until documented recurrence or death from any cause.

Secondary Outcome Measures

Name	Time	Method
3 year overall survival (OS)	Three years after surgery	The time from surgery until documented death from any cause
Incidence of surgical complications	Until four weeks after surgery
Distribution of metastatic LNs	Two weeks after surgery	Lymph nodes retrieved from resected surgical specimens to categorise
Completeness of mCME	Two weeks after surgery	A. By reviewing resected surgical specimens based on photographs B. By reviewing the operative field after lymph node dissection and specimen removal based on photographs

Trial Locations

Locations (1)

Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of