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

NCT ID: NCT03992599

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2024-10-31

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.

Conditions

Adenocarcinoma of the Colon

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Laparoscopic modified central mesocolic excision

Patients receiving laparoscopic colectomy with the concept of modified complete mesocolic excision for right-sided colon cancer

Laparoscopic modified complete mesocolic excision

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Laparoscopic right hemicolectomy

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

References

Yang SY, Kim MJ, Kye BH, Han YD, Cho MS, Jeong SY, Cho HM, Kim H, Kang GH, Song SH, Park JS, Kim JS, Park SY, Kim J, Min BS. Prospective study of oncologic outcomes after laparoscopic modified complete mesocolic excision for non-metastatic right colon cancer (PIONEER study): study protocol of a multicentre single-arm trial. BMC Cancer. 2020 Jul 14;20(1):657. doi: 10.1186/s12885-020-07151-2.

Reference Type: DERIVED

PMID: 32664881 (View on PubMed)

Other Identifiers

4-2018-1162

Identifier Type: -

Identifier Source: org_study_id