Clinical trial NCT03992599: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adenocarcinoma of the Colon
Keywords: Adenocarcinoma in right colon
mCME
oncologic outcomes
right-sided colon cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 250
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: 3 year disease-free survival (DFS)
timeFrame: DFS will be measured up to three years after surgery, and the last visit is 14th visit after index surgery.
Secondary outcomes:
measure: 3 year overall survival (OS)
timeFrame: Three years after surgery
measure: Incidence of surgical complications
timeFrame: Until four weeks after surgery
measure: Completeness of mCME
timeFrame: Two weeks after surgery
measure: Distribution of metastatic LNs
timeFrame: Two weeks after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine
Study officials:
References:
citation: 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.