Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03992599
Recruitment Status : Enrolling by invitation
First Posted : June 20, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date June 18, 2019
First Posted Date June 20, 2019
Last Update Posted Date October 4, 2019
Actual Study Start Date August 1, 2019
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2019)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03992599 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 18, 2019)
  • 3 year overall survival (OS) [ Time Frame: Three years after surgery ]
    The time from surgery until documented death from any cause
  • Incidence of surgical complications [ Time Frame: 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
  • Distribution of metastatic LNs [ Time Frame: Two weeks after surgery ]
    Lymph nodes retrieved from resected surgical specimens to categorise
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Study of Oncologic Outcomes After Laparoscopic Modified Complete Mesocolic Excision for Non-metastatic Right Colon Cancer [PIONEER Study]
Official Title Prospective Study of Oncologic Outcomes After Laparoscopic Modified Complete Mesocolic Excision for Non-metastatic Right Colon Cancer [PIONEER Study]: Multicenter, Single-Arm Study
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
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
Condition Adenocarcinoma of the Colon
Intervention 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 Name: Laparoscopic right hemicolectomy
Study Groups/Cohorts Laparoscopic modified central mesocolic excision
Patients receiving laparoscopic colectomy with the concept of modified complete mesocolic excision for right-sided colon cancer
Intervention: Procedure: Laparoscopic modified complete mesocolic excision
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 18, 2019)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03992599
Other Study ID Numbers 4-2018-1162
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor Yonsei University
Collaborators Not Provided
Investigators Not Provided
PRS Account Yonsei University
Verification Date October 2019