Latitude - Lateral Lymph Node Attitude Study

Официальное название

Lateral Lymph Nodes in Rectal Cancer Attitude Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Local recurrence [Срок оценки: Three years]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Dept. of Surgery, Sahlgrenska University Hospital/Ostra — Gothenburg

Идентификаторы

NCT: NCT06896578 · Latitude

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗