Comparing two surgery methods for right-sided colon cancer

Trial details

Who runs it

Odense University Hospital

Trial code

NCT05230329

Record updated

8 February 2022

Original description

Our aim of this study is to compare the difference in lymph node yield in CME specimens versus those patients having a standard right hemicolectomy for right sided cancer .The secondary aim of this study was to investigate whether there is an interaction between greater lymph node harvest towards increased survival. Another subgroup analysis of this study is to compare the complications and oncological outcome between laparoscopic versus Robotic CME.Read full original descriptionShow less

CME Versus Standard Right Hemicolectomy for Right Sided Cancers

Our aim of this study is to compare the difference in lymph node yield in CME specimens versus those patients having a standard right hemicolectomy for right sided cancer .The secondary aim of this study was to investigate whether there is an interaction between greater lymph node harvest towards increased survival. Another subgroup analysis of this study is to compare the complications and oncological outcome between laparoscopic versus Robotic CME.

Trial Title CME versus standard right hemicolectomy for right sided cancers Internal ref. no. Clinical Phase Trial Design Observational, prospective, international, multi-center study Trial sites 10 sites over 5 different countries Planned Sample Size At least 330 subjects will be enrolled in this study per cohort, including 10% of lost to follow-up patients).

All patients during the enrolment period shall be screened and recorded at sites in order to identify any selection bias Treatment duration 3 years Follow up duration 5 years Planned Trial Period 10 years Objectives Outcome Measures Primary To compare the lymph node yield between complete mesocolic excision versus standard right hemicolectomy for patients with right sided cancer Number of harvested lymph nodes Secondary Incidence of local recurrence after surgery at 2 and 5 years

Disease free survival (2 and 5 years)

5-year overall survival

30-day and 90-day mortality,

60-day postoperative major complications (As measured by the Comprehensive Complication Index (CCI®).)

Pathological quality assessment. Completeness of mesocolon excision (CME) will be assessed by the pathologist

Operative length of time (total OR utilisation time and operative time skin to skin, minutes)

Assessment of intraoperative adverse events within advanced minimally-invasive surgery in order to report "near misses" and associated impact upon clinical outcomes

Conversion to open surgery

For Minimally invasive CME or standard right hemicolectomy - to compare the types of anastomosis (intra-corporeal versus Extra-coporeal ) on anastomosis leak rate 4. 5. 6. 7. Recurrence picked up on intensive follow up schedules with yearly CT scan for 5 years

Definitions:

Distal resected margin ≥ 5cm Lymph node yield Mesocolic plane of surgery Central vascular ligation (within 1cm of ileocolic vessels origins) R0 resection (all margins clear)

Investigational Medicinal Product(s) n/a Formulation, Dose, Route of Administration n/a

Inclusion: Participant is willing and able to give informed consent for participation in the trial; Male or Female, aged 18 years or above; Undergoing CME or standard right hemicolectomy surgery for right-sided cancer after MDT discussion; Cancer must be confirmed by histological, radiological, endoscopic diagnosis; In the Investigator's opinion, is able and willing to comply with all trial requirements.

Exclusion: Synchronous surgical procedure planned with CME or right hemicolectomy; Urgent, unplanned or emergency surgery; Neoadjuvant chemotherapy administered to treat this cancer prior to resection; Concurrent or previous abdominal or pelvic malignancy within five years prior to registration irrespective of treatment modality; Evidence of T4 disease invading adjacent organs; Known Crohn's disease with active terminal ileal disease; Evidence of systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude surgery, or other severe incapacitating disease, i.e. ASA IV (a patient with severe systemic disease that is a constant threat to life) or ASA V (a moribund patient who is not expected to survive without the operation); Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial; Female participant who is pregnant, lactating or planning pregnancy during the course of the trial; Participant with life expectancy of less than 6 months; Distal Transverse colon and splenic flexure tumors.

ClinicalTrials.gov NCT05230329