Local Cecal Cancer - Optimization of Surgical Treatment

Study Overview
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Brief Summary
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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
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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). All patients will be randomly divided into two groups in a 1:1 ratio. Research group (ICR) - Laparoscopy ileocecal resection with extended D3 lymphadenectomy (including 201, 202, 203 and 213 groups of lymph nodes). The minimum distance from the tumor is 10 cm, along the line of adequate blood supply. Next step - formation of a manual double-row ileo-ascendo-anastomosis. Control group (RHC) - Laparoscopy right hemicolectomy with D3 lymphadenectomy (including 211, 212, 221, 222-rt groups of lymph nodes). Next step - formation of a manual double-row ileo-transverse-anastomosis. Expected Results. The ICR will improve the short-term results of treatment of patients with cecal cancer compared with the standard RHC technique without affecting long-term results.

Official Title
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Study of the Oncological Outcomes of Ileocecal Resection With D3 for Cecal Cancer

Conditions
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Colonic Neoplasms Malignant, Cecal Neoplasms

Intervention / Treatment
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* Procedure: ileocecal resection with extended D3 lymphadenectomy.
* Procedure: Right hemicolectomy with D3 lymphadenectomy.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age. ECOG status 0-2. Histologically confirmed adenocarcinoma of the colon. Clinical stage T1-3; N+; M0. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patients will be randomly divided into two groups in a 1:1 ratio. Research group (ICR) - Laparoscopy ileocecal resection with extended D3 lymphadenectomy (including 201, 202, 203 and 213 groups of lymph nodes). The minimum distance from the tumor is 10 cm, along the line of adequate blood supply. Next step - formation of a manual double-row ileo-ascendo-anastomosis. Control group (RHC) - Laparoscopy right hemicolectomy with D3 lymphadenectomy (including 211, 212, 221, 222-rt groups of lymph nodes). Next step - formation of a manual double-row ileo-transverse-anastomosis.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopy ileocecal resection with extended D3 lymphadenectomy.<br>Ileocecal resection with extended D3 lymphadenectomy. | Procedure: ileocecal resection with extended D3 lymphadenectomy.<br>* Laparoscopy ileocecal resectionith extended D3 lymphadenectomy including 201, 202, 203 and 213 groups of lymph nodes. Manual double-row ileo-ascendo-anastomosis.<br>|
| Experimental: Laparoscopy right hemicolectomy with D3 lymphadenectomy.<br>Right hemicolectomy with D3 lymphadenectomy | Procedure: Right hemicolectomy with D3 lymphadenectomy.<br>* Laparoscopy right hemicolectomy with D3 lymphadenectomy including 201, 202, 203, 213, 211, 212, 221, 222-rt groups of lymph nodes. Manual double-row ileo-transverse-anastomosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival. | Overall survival of patients. | 5 years after the last patient. | 
| Disease-free survival. | Survival without local or distant recurrence. | 3 years after the last patient. | 
| Disease-free survival. | Survival without local or distant recurrence. | 5 years after the last patient. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity. | Complications after surgery. | The first 30 days after surgery. | 
| Postoperative mortality. | Death after surgery. | The first 30 days after surgery. | 
| Total number of lymph nodes removed. | Number of removed lymph nodes according to pathomorphological evaluation. | Post-intervention at week 3. | 
| Total number of metastatic lymph nodes and correlation by group. | The ratio of affected lymph nodes into groups (201, 202, 203, 213, 211, 212, 221 or 222-rt) depending on the type of surgical treatment. Based on pathological assessment. | Post-intervention at week 3. | 
| Total length of removed bowel. | Average length of removed bowel in both groups according to pathomorphological evaluation (millimeters). | Post-intervention at week 3. | 
| Area of mesentery removed. | Average area of the removed mesentery in each groups according to pathomorphological evaluation (square centimetre - sq.cm). | Post-intervention at week 3. | 
| Description of blood loss during the intraoperative period. | Average blood loss during surgery in each group (ml). | During the surgery. | 
| Operation time. | Average operation time for each group (minutes - min). | Immediately after the surgery. | 
| Conversion. | The total number of conversions for each group. | During the surgery. | 
| Number of days of inpatient treatment. | Average number of days of inpatient treatment. | During hospitalization up to 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal cancer, Segmental colonic resection, Ileocecal resection, Cecal cancer, Right hemicolectomy