Local Cecal Cancer - Optimization of Surgical Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ileocecal resection with extended D3 lymphadenectomy., Right hemicolectomy with D3 lymphadenectomy..
- Who it may be relevant to
- Registry conditions: Colonic Neoplasms Malignant, Cecal Neoplasms. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study of the Oncological Outcomes of Ileocecal Resection With D3 for Cecal Cancer
Overview
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).
All patients will be randomly divided into two groups in a 1:1 ratio.
1. 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. 2. 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.
Interventions
- Procedure ileocecal resection with extended D3 lymphadenectomy.
Laparoscopy ileocecal resectionith extended D3 lymphadenectomy including 201, 202, 203 and 213 groups of lymph nodes. Manual double-row ileo-ascendo-anastomosis. - Procedure Right hemicolectomy with D3 lymphadenectomy.
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.
Primary outcome measures
- Overall survival. [Time frame: 5 years after the last patient.]
- Disease-free survival. [Time frame: 3 years after the last patient.]
- Disease-free survival. [Time frame: 5 years after the last patient.]
Secondary outcome measures (10)
- Postoperative morbidity. [Time frame: The first 30 days after surgery.]
- Postoperative mortality. [Time frame: The first 30 days after surgery.]
- Total number of lymph nodes removed. [Time frame: Post-intervention at week 3.]
- Total number of metastatic lymph nodes and correlation by group. [Time frame: Post-intervention at week 3.]
- Total length of removed bowel. [Time frame: Post-intervention at week 3.]
- Area of mesentery removed. [Time frame: Post-intervention at week 3.]
- Description of blood loss during the intraoperative period. [Time frame: During the surgery.]
- Operation time. [Time frame: Immediately after the surgery.]
- Conversion. [Time frame: During the surgery.]
- Number of days of inpatient treatment. [Time frame: During hospitalization up to 4 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Moscow Clinical Scientific Center — Moscow
Identifiers
NCT: NCT06121089 · 10/2022