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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopy ileocecal resection with extended D3 lymphadenectomy. | Active Comparator | Ileocecal resection with extended D3 lymphadenectomy. |
|
| Laparoscopy right hemicolectomy with D3 lymphadenectomy. | Experimental | Right hemicolectomy with D3 lymphadenectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ileocecal resection with extended D3 lymphadenectomy. | Procedure | Laparoscopy ileocecal resectionith extended D3 lymphadenectomy including 201, 202, 203 and 213 groups of lymph nodes. Manual double-row ileo-ascendo-anastomosis. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morbidity. | Complications after surgery. | The first 30 days after surgery. |
| Postoperative mortality. | Death after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the number and level of lymph node involvement. | X-ray assessment (Node-RADS classification) of clinical stage (N0 or N+) and distribution of suspicious lymph nodes into groups. | Period of examination before surgery. |
| Quality of life in patients after ICR and RHC using questionnaire. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Igor Matveev | Contact | +7(916)182-17-46 | i.matveev@mknc.ru | |
| Mikhail Danilov | Contact | +7(967) 136-76-87 | m.danilov@mknc.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Clinical Scientific Center | Recruiting | Moscow | Russia |
We are not planning to share personal patient data.
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| ID | Term |
|---|---|
| D002430 | Cecal Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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All patients will be randomly divided into two groups in a 1:1 ratio.
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| Right hemicolectomy with D3 lymphadenectomy. | Procedure | 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. |
|
| 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 |
Questionnaires by European Organization for Research and Treatment of Cancer. EORTC QLQ - CR29. |
| 30 days post-surgery. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D003108 | Colonic Diseases |
| D012002 | Rectal Diseases |