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Not yet recruiting NCT06896578

Latitude - Lateral Lymph Node Attitude Study

No phase Interventional Rectal Neoplasm Malignant

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: Lateral lymph node dissection.
Who it may be relevant to
Registry conditions: Rectal Neoplasm Malignant. 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
Sweden
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

Lateral Lymph Nodes in Rectal Cancer Attitude Study

Overview

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.

Detailed description

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.

Interventions

  • Procedure Lateral lymph node dissection
    Removal of lateral lymph nodes in the obturator and internal iliac compartment including fatty tissue, but excluding vascular and nervous tissue

Primary outcome measures

  • Local recurrence [Time frame: Three years]
Secondary outcome measures (12)
  • Complications according to a composite outcome [Time frame: 90 days]
  • Lateral local recurrence [Time frame: 3 years]
  • Lateral local recurrence [Time frame: 5 years]
  • Surgical morbidity (including reoperations) (Clavien Dindo score I-V) [Time frame: 90 days]
  • Surgical morbidity measured as Comprehensive Complications index (lower score = less complications) [Time frame: 90 days]
  • Perioperative blood loss [Time frame: 0-24 hours]
  • Total operating time [Time frame: 0-24 hours]
  • Length of hospital stay [Time frame: during the first hospitalization until discharge after first surgery, measured within 3 months of the first surgical proceu]
  • Total length of hospital stay [Time frame: 365 days = 1 year]
  • Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis) [Time frame: 1 year]
  • Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis) [Time frame: 2 years]
  • Number of patients with postoperative thrombosis (deep venous thrombosis and/or pulmonary thrombosis) [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • 18 years or older
  • written informed consent
  • adenocarcinoma verified tumour below ≤ 8 cm from anal verge measured by rectoscopy and/or MRI
  • clinical tumor (cT) stage cT3, cT4a or cT4b on MRI or
  • adenocarcinoma verified tumour at any height ≤ 15 cm from anal verge measured by rectoscopy and/or MRI regardless of T/N stage with visible lateral lymph node (according to definition 2.4.2) on pre-therapeutic MRI or PET-CT

Exclusion criteria

  • Not biopsy confirmed rectal cancer (adenocarcinoma)
  • Recurrent rectal cancer
  • Age below 18
  • Participation in other trials in conflict with the protocol and end-points of the Latitude study
  • No informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 1 center
  • Dept. of Surgery, Sahlgrenska University Hospital/Ostra — Gothenburg

Identifiers

NCT: NCT06896578 · Latitude

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗