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

October 1, 2019 updated by: Yonsei University

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Laparoscopic right hemicolectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 year disease-free survival (DFS)
Time Frame: 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.
DFS will be measured up to three years after surgery, and the last visit is 14th visit after index surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3 year overall survival (OS)
Time Frame: Three years after surgery
The time from surgery until documented death from any cause
Three years after surgery
Incidence of surgical complications
Time Frame: Until four weeks after surgery
Until four weeks after surgery
Completeness of mCME
Time Frame: 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
Two weeks after surgery
Distribution of metastatic LNs
Time Frame: Two weeks after surgery
Lymph nodes retrieved from resected surgical specimens to categorise
Two weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2019

Primary Completion (ANTICIPATED)

July 1, 2024

Study Completion (ANTICIPATED)

October 1, 2024

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

June 18, 2019

First Posted (ACTUAL)

June 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2019

Last Update Submitted That Met QC Criteria

October 1, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2018-1162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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