Minimally Invasive Simultaneous Colorectal and Liver Surgery
Robot-assisted Resection of Colorectal Cancer and Synchronous Liver Metastases:Preliminary Experience, Technique and Literature Review
Up to 25% of newly diagnosed patients with colorectal cancer (CRC) have liver metastases (LM). Simultaneous colorectal and hepatic resection has been proven to be a safe and effective approach in dealing with metastatic colorectal cancer.
The aim of this paper is to analyse perioperative and oncological outcomes of minimally invasive (laparoscopic and robotic) one-stage simultaneous resection of liver metastases and colorectal tumor in selected patients affected by colorectal cancer and synchronous liver metastases.
調査の概要
詳細な説明
From October 2012 to March 2018 a minimally invasive one-stage resection was offered to selected patients referred to the investigator's institution with a diagnosis of CRC and synchronous LM, irrespective of the size and location of the primary and metastatic disease. When feasible, a fully-robotic colorectal and liver resection was performed. Prior consent was obtained and full treatment options where submitted to all patients treated. Data collected were prospectively analyzed.
Diagnosis and pre-operative staging were achieved with pancolonoscopy with biopsies and, where contraindicated or not feasible, with CT colonography.
Pelvic MRI with rectal cancer protocol was used for local staging of rectal cancer and total-body contrast-enhanced computed tomography (CT) and liver contrast-enhanced magnetic resonance imaging (MRI) for investigation of metastases. In selected cases a CEUS (contrast-enhanced ultrasound) or liver biopsy was performed in order to achieve a diagnostic definition.
All cases were discussed at multidisciplinary team meeting. Criteria for neoadjuvant chemotherapy were liver unresectability with a potential incomplete liver resection with anticipated positive surgical margins and an insufficient liver remnant.
Absolute contraindications for minimally invasive simultaneous surgery were considered unfitness for surgery due to comorbidities not allowing long operative time, the number of lesions in parenchymal sparing surgery (generally >5), the pre-operative prediction of vascular resection.
Relative contraindications were considered the need for major hepatectomy and the finding of new intraoperative lesions, with consequent potential longer operative time.
Demographic, histopathological, surgical morbidity/mortality and short term peri-operative clinical outcome in all patients undergone simultaneous colorectal and liver resections were prospectively evaluated.
Morbidity evaluation included all intra-operative and early post-operative (within 30 days) complications and rated according to Clavien-Dindo classification.
All data are expressed as mean values ± range when appropriate
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Perugia
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Foligno、Perugia、イタリア、06034
- 募集
- Michele De Rosa
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コンタクト:
- Michele De Rosa
- 電話番号:+393397871350
- メール:michele.derosa@nhs.net
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-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- colorectal primary tumor with synchronous liver metastases
- eligibility for minimally-invasive surgery
Exclusion Criteria:
- unfitness for prolonged operative time
- liver lesions >5
- pre-operative prediction of vascular resection
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
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
Synchronous colorectal cancer and liver metastases
Robotic (Da Vinci) one-stage colorectal and liver resection
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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 |
---|---|---|
Short-term perioperative surgical outcomes
時間枠:intra-operative - within 30 post-operative day
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Morbidity
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intra-operative - within 30 post-operative day
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Mortality
時間枠:Intra-operative -within 30 post-operative day
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Intra-operative -within 30 post-operative day
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|
Blood loss
時間枠:Intra-operative
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Measured in mL
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Intra-operative
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Conversion rate
時間枠:Intra-operative
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Intra-operative
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Operative time
時間枠:Intra-operative
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Measured in minutes
|
Intra-operative
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (予想される)
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
その他の研究ID番号
- AOSGB1
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?
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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大腸がんの臨床試験
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