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
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|
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]|
|Estimated Enrollment :||250 participants|
|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|
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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992599
|Korea, Republic of|
|Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine|
|Seoul, Korea, Republic of|