A Prospective Randomized Trial of Efficacy of Stump Closure for Distal Pancreatectomy
調査の概要
詳細な説明
Pancreatic surgery has been called formidable operation not only the technical challenge to surgeons but also demanding for patients. It evolved into a safe procedure with mortality rates of <5% recently, cutting down gradually from 25% in the 1960s. However, overall morbidity rate remained high ranging from 30% to 60%.
Distal pancreatectomy (DP) has been believed a safer and minor procedure compared with pancreatic head resection including standard pancreaticoduodenectomy (PD), pylorus-preserving pancreaticoduodenectomy (PPPD), or duodenum-preserving pancreatic head resection (DPPHR). Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the most common complications after DP. Büchler et al observed that the POPF rate was in fact significantly higher after DP when compared to pancreatic head resections. The variable documented incidence of POPF following DP ranges from 12% to 40%. POPF after DP is also associated with major complications such as bleeding or septic shock and remains an equivocal problem.
Although the majority of complications are not life-threatening, POPF could prolong hospitalization, expend expenditure for healthcare, abrade the quality of life; moreover, delay in further management for a fraction of patients with malignancy. Over the past two decades, various risk factors and multitudinous operative procedures have been held for reduction POPD following DP. These include underlying disease process, method of stump closure, and concomitant splenectomy However, all these reports were retrospective review, non-randomized study, or individual experience. As always, this issue remains in obscurity and seek for a more concrete evidence to solve.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Taipei city、台湾、10002
- 募集
- National Taiwan University Hospital
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コンタクト:
- Ting-Chun Kuo, MD
- 電話番号:63746 +886-2-23123456
- メール:tina@ntuh.gov.tw
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コンタクト:
- Yu-Wen Tien, PhD
- 電話番号:65083 +886-2-23123456
- メール:ywtien5106@ntu.edu.tw
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- age>= 20 years
- scheduled distal pancreatectomy at NTUH
- unable to realize this trial and willing to sign the informed consent form
Exclusion Criteria:
- age< 20 years, pregnent women, breast-feeding women, or mentally illed
- active malignancy within 2 years
- received other upper abdomen major surgery
- scheduled spleen preservation or associated major organ 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
- 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:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ:Conventional
Stump closure as our institute routine, using interrupted silk mattress suture and continuous prolene sutures.
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We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.
他の名前:
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実験的:Surgicel
Stump closure modified from our institute routine, using interrupted silk mattress suture and continuous prolene sutures with NU-KNIT SURGICEL overlying for reinforcement.
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We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.
他の名前:
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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 |
|---|---|---|
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POPF rate
時間枠:through study completion, an average of 16 days
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The percentage of overall (grade A, B, C) POPF.
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through study completion, an average of 16 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Duration of drainage replacement
時間枠:through study completion, an average of 16 days
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Duration of drainage replacement after DP
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through study completion, an average of 16 days
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Hospitalization
時間枠:through study completion, an average of 16 days
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Duration of hospital stay after DP
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through study completion, an average of 16 days
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Hospitalization cost
時間枠:through study completion, an average of 16 days
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Total hospital cost of for DP
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through study completion, an average of 16 days
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Mortality
時間枠:90 days
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Procedure-related mortality after DP
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90 days
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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 (予想される)
一次修了 (予想される)
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
- 201507019RIND
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
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膵瘻の臨床試験
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Washington University School of MedicineUniversity of Oklahoma Medical Center; Northwestern University Chicago Illinois; Saint Luke's...完了
Stump closure using NU-KNIT SURGICELの臨床試験
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Hamad Medical Corporation完了