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Идёт набор NCT07479277

Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC

Без фазы С лечением Non-Small Cell Lung Cancer Postoperative Air Leak NSCLC

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: Progel Platinum, Mechanical Stapling.
Кому может быть актуально
Состояния в реестре: Non-Small Cell Lung Cancer, Postoperative Air Leak, NSCLC. Базовые параметры: 18 лет — 99 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
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multicenter, Randomized, Parallel-Group Trial Evaluating Progel Platinum Added to Mechanical Stapling Versus Mechanical Stapling Alone in Patients Undergoing VATS Upper or Lower Lobectomy for Non-Small Cell Lung Cancer

Обзор

This multicenter randomized trial evaluates whether routine use of Progel Platinum surgical sealant on stapled fissure lines during VATS upper or lower lobectomy for NSCLC reduces pleural drainage duration compared with standard stapling alone. Secondary objectives include postoperative length of stay, incidence and duration of postoperative air leaks, residual pleural space, safety outcomes, and hospitalization costs.

Подробное описание

Lobectomy is the standard surgical treatment for many patients with early-stage NSCLC, but postoperative air leak remains a frequent complication associated with prolonged chest tube duration, longer hospitalization, and increased healthcare costs. Preliminary non-randomized evidence suggests that Progel Platinum may improve intraoperative sealing of fissure lines and reduce postoperative air leaks. E-SEAL is a prospective, randomized, controlled, multicenter study in 8 thoracic surgery centers. Eligible adult patients undergoing minimally invasive VATS upper or lower lobectomy for NSCLC are randomized 1:1 to stapling alone or stapling plus Progel Platinum. The primary endpoint is pleural drainage duration in hours. Secondary endpoints include postoperative length of stay, hospitalization costs, postoperative air leak incidence and volume, residual pleural space, complications, re-interventions, and follow-up outcomes up to 60 days after surgery/discharge.

Вмешательства

  • Устройство Progel Platinum
    Progel Platinum surgical sealant applied to the completed fissure line after stapled fissure completion during VATS upper or lower lobectomy
  • Процедура Mechanical Stapling
    Standard mechanical stapling used for fissure completion during VATS upper or lower lobectomy.

Первичные конечные точки

  • Duration of pleural drainage [Срок оценки: From surgery to chest tube removal, assessed up to 30 days after surgery]
Вторичные конечные точки (8)
  • Postoperative hospital length of stay [Срок оценки: From surgery to hospital discharge, assessed up to 30 days after surgery]
  • Incidence and volume of postoperative air leaks [Срок оценки: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery]
  • Incidence of residual pleural space [Срок оценки: During postoperative hospitalization and at follow-up visits at 1 month and 2 months after discharge]
  • Postoperative safety outcomes [Срок оценки: During postoperative hospitalization and up to 30 days after surgery]
  • Duration of postoperative air leak [Срок оценки: From surgery to resolution of postoperative air leak during postoperative hospitalization, assessed up to 30 days after surgery]
  • Duration of surgical procedure [Срок оценки: During the surgical procedure]
  • Mean daily and total postoperative air leak volume [Срок оценки: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery]
  • Air leak indices corrected for length of dissected pulmonary parenchyma [Срок оценки: Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Written informed consent
  • Planned VATS upper or lower lobectomy for NSCLC
  • Minimally invasive thoracoscopic approach
  • Middle lobectomy excluded

Критерии исключения

  • Induction radiochemotherapy or chemo-immunotherapy
  • Severe COPD: GOLD 3 or higher
  • Sleeve resection or extended resection involving other lobes/chest wall/pericardium, etc.
  • Albumin intolerance/allergy
  • Renal insufficiency
  • Redo surgery
  • Use of sealants/adhesives other than the study approach
  • Expected extensive pleural adhesions

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

Италия · 6 центров
  • Unità di Chirurgia Toracica Oncologica — Candiolo
  • Ospedale centrale di Bolzano, Chirurgia Toracica e Vascolare — Bolzano
  • Azienda Ospedaliero-Universitaria Careggi — Florence
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan
  • Irccs Ismett — Palermo
  • Azienda Ospedaliera-Universitaria Pisana — Pisa

Идентификаторы

NCT: NCT07479277 · 001-FPO26

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗