Study of the Oncological Outcomes of Ileocecal Resection With D3 for Cecal Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Overall survival.
Study Overview
Brief Summary
The purpose of this study is to determine the clinical efficacy, safety, and oncologic outcomes of ileocecal resection (ICR) with D3 lymphadenectomy compared to standard right hemicolectomy(RHC) for cecal cancer.
Detailed Description
The design involves random allocation of eligible patients to ICR or RHC group in 1:1 ratio.
Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience.
Regular quality control includes the requirement to photograph the surgical specimen with a mark to determine the extent of lymphadenectomy performed and the number of the lymph node group.
After surgery patients are treated according to local standards, regardless of whether ICR or RHC was performed. Short-term and long-term outcomes are recorded according to the protocol.
Intervention. In all cases the tumor is localized in the area of the cecum; the border of the transition to the ascending colon is the upper lip of the ileocecal valve. The patient is not included in the study if the preoperative stage of examination reveals: synchronous cancer, distant metastasis (M1), locally advanced nature of the primary tumor (cT > 3).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At least 18 years of age.
- •ECOG status 0-
- •Histologically confirmed adenocarcinoma of the colon.
- •Clinical stage T1-3; N+; M
- •The physical status from ASA classification I, II, III or IV.
- •Written informed consent.
Exclusion Criteria
- •Synchronous or metachronous malignancy.
- •Locally-advanced tumor (T>3).
- •Presence of distant metastases (M1).
- •Complicated tumor: obstruction, perforation.
- •Neoadjuvant chemotherapy.
- •Medical contraindications for surgical treatment.
- •Pregnancy or breast feeding.
- •Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol.
Arms & Interventions
Laparoscopy ileocecal resection with extended D3 lymphadenectomy.
Ileocecal resection with extended D3 lymphadenectomy.
Intervention: ileocecal resection with extended D3 lymphadenectomy. (Procedure)
Laparoscopy right hemicolectomy with D3 lymphadenectomy.
Right hemicolectomy with D3 lymphadenectomy
Intervention: Right hemicolectomy with D3 lymphadenectomy. (Procedure)
Outcomes
Primary Outcomes
Overall survival.
Time Frame: 5 years after the last patient.
Overall survival of patients.
Disease-free survival.
Time Frame: 5 years after the last patient.
Survival without local or distant recurrence.
Disease-free survival.
Time Frame: 3 years after the last patient.
Survival without local or distant recurrence.
Secondary Outcomes
- Operation time.(Immediately after the surgery.)
- Number of days of inpatient treatment.(During hospitalization up to 4 weeks)
- Total number of metastatic lymph nodes and correlation by group.(Post-intervention at week 3.)
- Description of blood loss during the intraoperative period.(During the surgery.)
- Conversion.(During the surgery.)
- Postoperative morbidity.(The first 30 days after surgery.)
- Postoperative mortality.(The first 30 days after surgery.)
- Total number of lymph nodes removed.(Post-intervention at week 3.)
- Total length of removed bowel.(Post-intervention at week 3.)
- Area of mesentery removed.(Post-intervention at week 3.)