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

Adenocarcinoma of the Colon Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03992599
• Other study ID #: 4-2018-1162
• Status: Enrolling by invitation
• Start date: August 1, 2019
• Est. completion date: October 2024

Study information

• Verified date: October 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: October 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Colon
• Colonic Neoplasms

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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Colon and Rectal Surgery, Department of Surgery, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3 year disease-free survival (DFS)	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	3 year overall survival (OS)	The time from surgery until documented death from any cause	Three years after surgery
Secondary	Incidence of surgical complications		Until four weeks after surgery
Secondary	Completeness of mCME	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
Secondary	Distribution of metastatic LNs	Lymph nodes retrieved from resected surgical specimens to categorise	Two weeks after surgery