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

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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

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.


Condition or disease Intervention/treatment
Adenocarcinoma of the Colon Procedure: Laparoscopic modified complete mesocolic excision

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : October 2024

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 Name: Laparoscopic right hemicolectomy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 3 year overall survival (OS) [ Time Frame: Three years after surgery ]
    The time from surgery until documented death from any cause

  2. Incidence of surgical complications [ Time Frame: Until four weeks after surgery ]
  3. 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

  4. Distribution of metastatic LNs [ Time Frame: Two weeks after surgery ]
    Lymph nodes retrieved from resected surgical specimens to categorise



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992599


Locations
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Korea, Republic of
Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03992599     History of Changes
Other Study ID Numbers: 4-2018-1162
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Adenocarcinoma in right colon
mCME
oncologic outcomes
right-sided colon cancer
Additional relevant MeSH terms:
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Colonic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Adenocarcinoma
Carcinoma