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| Name | Class |
|---|---|
| Göteborg University | OTHER |
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Patients with advanced rectal cancer can sometimes have suspected tumour affected lymph nodes outside the standard operating field. These patients often receive preoperative treatment before surgery. There is a lack of consensus on what to do if there is remaining suspicion of tumour affected lymph nodes after the preoperative treatment. Removal of the lymph nodes using a broader surgical field with dissection of the lateral side-wall is often suggested, but the oncologic outcome is uncertain, and so is the patient reported outcome in terms of side effects.
This study aims to study the surgical treatment of tumour affected lateral lymph nodes to understand what lymph nodes require removal, and what effect that will have on oncologic outcome and the patient's function and QoL.
Patients with advanced rectal cancer will receive standard care, if lateral lymph nodes exist after neoadjuvant treatment they will be operated accordingly. The focus will be to compare two groups (with and without lateral lymph node clearance) regarding function, QoL and oncologic outcome.
We will also aim to identify features on MRI to improve diagnostic ability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectal cancer surgery without lateral lymph node dissection | No Intervention | Rectal cancer surgery without lateral lymph node dissection. Applicable if no lateral lymph nodes on primary MRI or lateral lymph nodes ≤4 mm after neoadjuvant treatment No lateral lymph node dissection | |
| Rectal cancer surgery with lateral lymph node dissection | Experimental | Rectal cancer surgery with lateral lymph node dissection. Applicable if lateral lymph nodes on primary MRI that persist after neoadjuvant treatment (> 4 mm) . Lateral lymph node dissection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lateral lymph node dissection | Procedure | Removal of lateral lymph nodes in the obturator and internal iliac compartment including fatty tissue, but excluding vascular and nervous tissue |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence | A tumour recurrence within the lesser pelvis, below the level of the promontory. (This does not include carcinomatosis if there are other signs of carcinomatosis in the abdominal cavity). Diagnosis made clinically (radiology) or by pathology | Three years |
| Measure | Description | Time Frame |
|---|---|---|
| Complications according to a composite outcome | Composite outcome including:
| 90 days |
| Lateral local recurrence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Angenete, MD PhD | Contact | +46760514441 | eva.angenete@vgregion.se |
| Name | Affiliation | Role |
|---|---|---|
| Eva Angenete, MD PhD | Sahlgrenska Universitetssjukhuset | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Surgery, Sahlgrenska University Hospital/Ostra | Gothenburg | SE 416 85 | Sweden |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Patients will be treated according to their findings on primary MRI. They will initiallly be divided into two groups: No neoadjuvant treatment or neoadjuvant treatment. If no neoadjuvant treatment the patients undergo rectal surgery.
If neoadjuvant treatment and lateral lymph nodes remain after neoadjuvant treatment (size >4 mm) then the patients will undergo lateral lymph node dissection.
If neoadjuvant treatment and lateral lymph nodes are ≤4 mm after neoadjuvant treatment then the patients will undergo rectal surgery.
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A tumour recurrence located in the lateral compartments within the lesser pelvis, below the level of the promontory. (This does not include carcinomatosis if there are other signs of carcinomatosis in the abdominal cavity). Diagnosis made clinically (radiology) or by pathology |
| 3 years |
| Lateral local recurrence | A tumour recurrence located in the lateral compartments within the lesser pelvis, below the level of the promontory. (This does not include carcinomatosis if there are other signs of carcinomatosis in the abdominal cavity). Diagnosis made clinically (radiology) or by pathology | 5 years |
| Surgical morbidity (including reoperations) (Clavien Dindo score I-V) | Clavien-Dindo IIIb and more measured as proportion | 90 days |
| Surgical morbidity measured as Comprehensive Complications index (lower score = less complications) | All complications registered according to Clavien-Dindo using a calculator to identify a combination of the number and the severity of complications. | 90 days |
| Perioperative blood loss | Blood loss during the surgical procedure: Registration in operative CRF (ml in suction + estimation by anaesthesiologist) | 0-24 hours |
| Total operating time | Registration in operative CRF (op start and op end) | 0-24 hours |
| Length of hospital stay | Total days in hospital including referral to other hospital | during the first hospitalization until discharge after first surgery, measured within 3 months of the first surgical proceu |
| Total length of hospital stay | Total number of days including readmissions | 365 days = 1 year |
| Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis) | Clinical or radiological or patient reported thromobsis | 1 year |
| Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis) | Clinical or radiological or patient reported thromobsis | 2 years |
| Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis) | Clinical or radiological or patient reported thromobsis | 3 years |
| Health related Quality of life | Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL. | 1 month postop |
| Health related Quality of life | Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL. | 1 year |
| Health related Quality of life | Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL. | 2 years |
| Health related Quality of life | Health related QoL, Measured in QoL questionnaire, a likert scale question 1-7 where 7 is the best possible QoL. | 3 years |
| Urinary function | Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach. | 1 month |
| Urinary function | Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach. | 1 year |
| Urinary function | Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach. | 2 years |
| Urinary function | Measured in QoL questionnaire focus on incontinence, emptying difficulties and urgency using direct questions, not a score. Clinimetric approach. | 3 years |
| Sexual function | Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach. | 1 year |
| Sexual function | Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach. | 2 years |
| Sexual function | Measured in QoL questionnaire, focus on both function and quality using direct questions, not a score. Clinimetric approach. | 3 years |
| Bowel and stoma function | Measured in QoL questionnaire, major LARS (21-42 points) | 1 year |
| Bowel and stoma function | Measured in QoL questionnaire, major LARS (21-42 points) | 2 years |
| Bowel and stoma function | Measured in QoL questionnaire, major LARS (21-42 points) | 3 years |
| Health economic analysis | A total health economic analysis including societal costs | 1 year |
| Mortality | Dead by any cause | 1 year |
| Mortality | Dead by any cause | 2 years |
| Mortality | Dead by any cause | 3 years |
| 5- year overall survival | Survival at 5 years | 5 years |
| Pain according to brief pain inventory | Measured in QoL questionnaire brief pain inventory with four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics | 1 month |
| Pain according to brief pain inventory | Measured in QoL questionnaire brief pain inventory with four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics | 1 year |
| Pain according to brief pain inventory | Measured in QoL questionnaire brief pain inventory with four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics | 2 years |
| Pain according to brief pain inventory | Measured in QoL questionnaire brief pain inventory with four pain severity items and seven pain interference items rated on 0-10 scales, and the question about percentage of pain relief by analgesics | 3 years |
| MRI interobserver variability | Comparing MRI assessment at baseline between different centers to determine specificity and sensitivity of MRI assessment | First month |
| MRI interobserver variability | Comparing MRI assessment at baseline between different centers to determine specificity and sensitivity of MRI assessment | First 6 months |
| MRI vs pathology | Comparing MRI assessment with pathology report, diagnostic (pretreatment) and post treatment MRI compared with pathology report | First 6 months |
| ctDNA at diagnosis | Value of ctDNA at diagnosis, the possible correlation with malignant lymph nodes | Values at diagnosis, perioperatively and post treatment in relation to cancer recurrence |
| Value of immunoscore to predict response, and presence of lateral lymph nodes | Is high Immunoscore related to malignant lymph nodes? Diagnostic biopsies will be sectioned, stained with immunohistochemistry will be correlated to lymph nodes on MRI | 1 month |
| Value of immunoscore to predict response, and presence of lateral lymph nodes | Is high Immunoscore related to malignant lymph nodes? Diagnostic biopsies will be sectioned, stained with immunohistochemistry will be correlated to lymph nodes on pathology | Perioperative biopsies (within 6 weeks from inclusion) |
| Evaluation dose/fraction in relation to response to treatment | Details from CRF during treatment planning as well as prospectively collected treatment plans | Within the first 6 months. |
| Evaluation of number of fractions n relation to response to treatment | Details from CRF during treatment planning as well as prospectively collected treatment plans | Within the first 6 months |
| Evaluation of final dose to tumor and elective LN volume | Details from CRF during treatment planning as well as prospectively collected treatment plans | Within the first 6 months |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |