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Идёт набор NCT07731958

Unilateral vs. Bilateral Lung Volume Reduction Surgery

Без фазы С лечением Emphysema, Pulmonary

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Unilateral LVRS, Bilateral LVRS.
Кому может быть актуально
Состояния в реестре: Emphysema, Pulmonary. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
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Официальное название

Unilateral Versus Bilateral Lung Volume Reduction Surgery for Patients With Severe COPD

Обзор

This study compares two surgical approaches for patients with severe Chronic Obstructive Pulmonary Disease (COPD) and severe emphysema: unilateral (operating on one lung) versus bilateral (operating on both lungs) lung volume reduction surgery (LVRS).

Подробное описание

Lung volume reduction surgery removes damaged lung tissue to help patients breathe better, improve life quality, and increase exercise capacity. Historically, the hospital has performed this surgery unilaterally, while global standards often favor bilateral surgery to maximize lung function benefits.Existing data suggesting bilateral surgery is better is more than 20 years old, lacks randomization, and was gathered before modern surgical advances like keyhole surgery (VATS) and Enhanced Recovery After Surgery (ERAS) protocols. Additionally, bilateral surgery may carry higher risks of postoperative complications, longer hospital stays, and prolonged air leaks. This study aims to provide modern, unbiased evidence to determine which approach is superior.

Вмешательства

  • Процедура Unilateral LVRS
    Both unilateral and bilateral LVRS are done with a standardized 3 port VATS access. Lower ligament is freed, no graspers on the parenchyma and stapling of the selected areas with a Signia™ powered stapler with Tri-Staple™ technology (Medtronic). The reloads will not be butressed and it will be vascular or parenchymal reloads. Two drains will be placed on the operated side and the same pain management will be applied including perioperative blocs and a pain catheter. The unilateral procedures wil
  • Процедура Bilateral LVRS
    Both unilateral and bilateral LVRS are done with a standardized 3 port VATS access. Lower ligament is freed, no graspers on the parenchyma and stapling of the selected areas with a Signia™ powered stapler with Tri-Staple™ technology (Medtronic). The reloads will not be butressed and it will be vascular or parenchymal reloads. Two drains will be placed on the operated side and the same pain management will be applied including perioperative blocs and a pain catheter. In the bilateral procedures t

Первичные конечные точки

  • Lung function [Срок оценки: 3 months and 12 months after surgery]
Вторичные конечные точки (1)
  • Mortality [Срок оценки: Thirty days from surgery]

Критерии участия

Критерии включения

  • Suitable target areas in both lungs
  • Age ≥ 18 years.
  • Speaks and understands Danish or English
  • Informed consent obtained
  • Usual inclusion criteria in LVRS:

Moderate to severe COPD with MRC score > 2 < 75 years old 17 < BMI > 30 FEV1 > 20% and < 45% of predicted RV > 200% of predicted as a sign of relevant hyperinflation DLCO > 20% of predicted The patient should be in ideal medical treatment and have completed rehabilitation A high-resolution CT < 3 months old should follow the referral to MDT Absence of nodules suspicious of malignancy on CT scan Absence of significant comorbidity including severe cardiovascular disease LVEF normal Absence of pulmonary hypertension, TI-gradient < 40 mmHg Absence of chronic or frequent lung infections Smoking abstinence six months prior to surgery Assessed as sufficiently physically fit to undergo surgery and rehabilitation

Критерии исключения

  • Dependent on wheelchair
  • Living in nursery home
  • Dependent on walker device
  • Psychiatric disorder (anxiety, depression, schizophrenia)
  • Simultaneous lung cancer surgery
  • Massive adhesions during surgery assessed by the surgeon indicating problems postoperatively
  • Increased risk of post-operative bleeding assessed perioperatively by the surgeon.
  • Perioperative decision on not doing operation on the other side (medical, surgical or anaesthesiologic problems that favours a fast termination of the surgery, decided by the team in OR).
  • Previous cardiothoracic surgery
  • Increased bleeding risk (e.g., preoperative INR >2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy).

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Дания · 1 центр
  • Rigshospitalet — Copenhagen

Идентификаторы

NCT: NCT07731958 · H-23033301

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗