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

NCT03992599 | Unknown DMC

• 1 other identifier: 4-2018-1162
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Colon

Keywords

Adenocarcinoma in right colon; mCME; oncologic outcomes; right-sided colon cancer

Outcome Measures

Primary Outcomes (1)

• 3 year disease-free survival (DFS)

  The 3 year disease-free survival is defined as the time from surgery until documented recurrence or death from any cause.

  DFS will be measured up to three years after surgery, and the last visit is 14th visit after index surgery.

Secondary Outcomes (4)

• 3 year overall survival (OS)

  Three years after surgery

• Incidence of surgical complications

  Until four weeks after surgery

• Completeness of mCME

  Two weeks after surgery

• Distribution of metastatic LNs

  Two weeks after surgery

Study Arms (1)

Laparoscopic modified central mesocolic excision

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

Procedure: Laparoscopic modified complete mesocolic excision

Interventions

Laparoscopic modified complete mesocolic excision 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.

Also known as: Laparoscopic right hemicolectomy

Laparoscopic modified central mesocolic excision

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with adenocarcinoma arising from the right side of the colon who received laparoscopic mCME. The right side of the colon was defined as the colon from cecum up to the proximal half of transverse colon

You may qualify if:

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

You may not qualify if:

• \. Informed consent refusal
• \. Patients who need emergency operation; such as perforation, malignant colonic obstruction
• \. Preoperative imaging examination results show: distant metastasis
• \. Hereditary colon cancer
• \. 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;
• \. Simultaneous or simultaneous multiple primary colorectal cancer
• \. Women during Pregnancy or breast feeding period

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32664881 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: August 1, 2019
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)