Comparison of Biportal Versus Multiportal Robotic Approaches for Pulmonary Resection in NSCLC (EC-UMUR)
Clinical Trial in Patients With Non-Small Cell Lung Cancer Undergoing Biportal Versus Multiportal Robotic Thoracic Surgery: Comparison of Two Innovative Techniques
調査の概要
状態
条件
詳細な説明
Robotic-assisted thoracic surgery is widely used for pulmonary resection in patients with resectable non-small cell lung cancer. Multiportal RATS uses several access ports. Biportal RATS uses two access incisions and aims to preserve minimally invasive benefits while improving ergonomic access and instrument maneuverability.
This single-center, prospective, randomized, partially blinded clinical trial will compare biRATS with multiRATS in adults undergoing pulmonary resection with curative intent at Hospital Universitari de Bellvitge. Eligible participants who provide written informed consent will be randomly assigned using the study REDCap randomization system. A standardized dressing will be maintained for 48 hours after surgery to support partial blinding.
The main analysis will compare intraoperative and immediate postoperative complications between groups. Additional assessments include intraoperative blood loss, conversion, chest-drain duration, hospital length of stay, postoperative pain, readmission, mortality, and health-related quality of life. Quality of life will be assessed using EQ-5D-5L, EORTC QLQ-C30, and EORTC QLQ-LC13; pain will be measured with a visual analogue scale and DN4 questionnaire. Follow-up occurs during hospitalization and at 1, 6, and 12 months after surgery.
The planned sample is 70 to 80 participants (approximately 35 per group). The study is investigator initiated and has CEIm approval (PR208/24; protocol version 3.0 dated June 18, 2025).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Carlos Déniz Armengol, MD, PhD
- 電話番号：2744 +34 932607500
- メール：cjdeniz@bellvitgehospital.cat
研究場所
-
-
Barcelona
-
L'Hospitalet de Llobregat、Barcelona、スペイン、08907
- 募集
- Hospital Universitari de Bellvitge
-
コンタクト：
- Carlos Déniz Armengol, MD, PhD
- 電話番号：2744 +34 932607500
- メール：cjdeniz@bellvitgehospital.cat
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged 18 years or older, of any sex.
- Non-small cell lung cancer considered clinically resectable, confirmed preoperatively or during surgery.
- Candidate for pulmonary resection by robotic thoracic surgery.
- Written informed consent.
Exclusion Criteria:
- Declines participation or cannot provide written informed consent.
- Thoracic anatomical abnormalities that preclude or materially affect robotic surgery.
- Active thoracic infection.
- Surgery not performed by a participating surgeon with comparable experience in biRATS and multiRATS.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：biRATS
Biportal robotic-assisted thoracic surgery for pulmonary resection using two access incisions.
|
Pulmonary resection performed with a biportal robotic-assisted thoracic surgery approach using two access incisions.
|
|
アクティブコンパレータ：multiRATS
Multiportal robotic-assisted thoracic surgery for pulmonary resection using multiple access ports.
|
Pulmonary resection performed with a multiportal robotic-assisted thoracic surgery approach using multiple access ports.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Intraoperative and Immediate Postoperative Complications
時間枠：From surgery through hospital discharge, up to 30 days
|
Proportion of participants with intraoperative or immediate postoperative complications, classified by Clavien-Dindo grade.
Events include, among others, prolonged air leak, pleuropulmonary infection, pneumothorax, postoperative hemorrhage, chylothorax, respiratory failure, wound infection, readmission, and perioperative death.
|
From surgery through hospital discharge, up to 30 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intraoperative Blood Loss
時間枠：During surgery
|
Estimated intraoperative blood loss in milliliters.
|
During surgery
|
|
Length of Hospital Stay
時間枠：From surgery through hospital discharge, up to 30 days
|
Number of days from surgery to medical discharge.
|
From surgery through hospital discharge, up to 30 days
|
|
Postoperative Pain Intensity (Visual Analog Scale)
時間枠：From baseline through 12 months after surgery
|
Pain intensity measured using the Visual Analog Scale (VAS), a 0 to 10 scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain.
|
From baseline through 12 months after surgery
|
|
Neuropathic Pain (Douleur Neuropathique 4 Questionnaire)
時間枠：From baseline through 12 months after surgery
|
Neuropathic pain assessed using the Douleur Neuropathique 4 (DN4) questionnaire, scored from 0 to 10. Scores of 4 or higher are consistent with neuropathic pain; higher scores indicate a greater likelihood of neuropathic pain.
|
From baseline through 12 months after surgery
|
|
Health Status (EuroQol 5-Dimension 5-Level Questionnaire)
時間枠：From baseline through 12 months after surgery
|
Health status assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) descriptive system.
Five dimensions are each rated from 1 (no problems) to 5 (extreme problems); lower levels indicate better health status.
|
From baseline through 12 months after surgery
|
|
Global Health Status/Quality of Life (EORTC QLQ-C30)
時間枠：From baseline through 12 months after surgery
|
Global health status/quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) global health status/QoL scale, transformed to a 0 to 100 score; higher scores indicate better global health status/quality of life.
|
From baseline through 12 months after surgery
|
|
Patient-Reported Lung Cancer Symptoms (EORTC QLQ-LC13)
時間枠：From baseline through 12 months after surgery
|
Lung cancer-related symptoms assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13).
Symptom scores are transformed to 0 to 100; higher scores indicate greater symptom burden.
|
From baseline through 12 months after surgery
|
|
Postoperative Healthcare Procedures
時間枠：From surgery through hospital discharge, up to 30 days
|
Number of additional medical procedures required during the index hospitalization, including chest-drain management interventions.
|
From surgery through hospital discharge, up to 30 days
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Carlos Déniz Armengol, MD, PhD、Hospital Universitari de Bellvitge
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- HUB-CTO-2024-01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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