NCT03992599

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenocarcinoma of the Colon

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic modified complete mesocolic excision	First, complete kocherization may be required to clear possible tumor spread if the tumor is infiltrating or adhering to the duodenum or perinephric fat tissue. Second, if the tumor is locally advanced, the entire prerenal soft tissue behind Gerota's fascia may need to be cleared, especially for tumors growing toward the posterior. The third difference of mCME with the conventional CME involves the tailored resection of the mesocolon and ileal mesentery according to tumor location. After identifying the root of the middle colic artery, the site of the vascular ligation depends on the location of the tumor. When the tumor is located in the cecum and ascending colon, only the right branch of the middle colic artery is ligated. If the tumor was present in these latter sites, the root of the middle colic artery is ligated.

Timeline

• Start date: 2019-08-01
• Primary completion: 2024-07-01
• Completion: 2024-10-01
• First posted: 2019-06-20
• Last updated: 2019-10-04

Locations

1 site across 1 country: South Korea