Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy
Development and Internal Validation of a Preoperative Risk Model for Clinically Relevant Postoperative Pancreatic Fistula Following Pancreaticoduodenectomy
Postoperative pancreatic fistula (POPF) especially clinically relevant POPF (CR-POPF; Grades B and C) is one of the critical and challenging post pancreaticoduodenectomy complications. Despite advances in surgical techniques, perioperative care, and centralization of pancreatic surgery Postoperative pancreatic fistula (POPF) remains an important cause for postoperative morbidity and
調査の概要
詳細な説明
Several risk prediction models have been developed to estimate the likelihood of CR-POPF, including the Fistula Risk Score (FRS), the Alternative Fistula Risk Score (a-FRS) and updated alternative Fistula Risk Score (ua-FRS). However, these models rely predominantly on intraoperative variables, such as pancreatic texture and main pancreatic duct diameter, limiting their value in preoperative risk stratification and patient counselling .
Despite the robustness of these scoring systems, certain aspects require further refinement. In particular, assessment of pancreatic texture remains largely subjective and dependent on intraoperative surgeon palpation, highlighting the need for more objective and quantitative methods. [3,4] Furthermore, elastography has emerged as a promising non-invasive technique for quantitative characterization of pancreatic tissue stiffness and has recently been investigated for preoperative prediction of clinically relevant postoperative pancreatic fistula; however, it has not yet been incorporated into the widely used fistula risk scoring systems.
Onodera's prognostic nutritional index (PNI) is calculated from serum albumin concentration and peripheral blood lymphocyte (PBL) count. It indicates the patient's nutritional and immunological status and is used to predict risk of several kinds of complications after surgery. Moreover, several preoperative nomograms and machine-learning models have demonstrated promising predictive performance for POPF. However, PNI has not been included in any of these scores.
Given the absence of an internally validated preoperative prediction model in the Egyptian population, this study aims to develop and internally validate a preoperative risk model for clinically relevant postoperative pancreatic fistula by incorporation of preoperative PNI and pancreatic texture assessment by elastography with previously emerged scores in patients undergoing pancreaticoduodenectomy. The proposed model may facilitate individualized risk stratification, optimize perioperative planning, improve patient counselling, and support evidence-based surgical decision-making
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Hisham Ali Riad Shaban Ali Riad Hisham Ali Riad Shaban, Professor of General Surgery
- 電話番号:01005015757
- メール:heshamreyad@aun.edu.eg
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
サンプリング方法
調査対象母集団
Patients undergoing elective pancreaticoduodenctomy
説明
Inclusion Criteria:
- Adults (≥18 years).
- Elective pancreaticoduodenectomy.
- Benign or malignant periampullary and pancreatic lesions.
Exclusion Criteria:
- - Total pancreatectomy.
- Distal pancreatectomy.
- Missing essential preoperative data.
- Death within 24 hours after surgery.
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
- 観測モデル:COHORT
- 時間の展望:PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
preoperative risk model for clinically relevant postoperative pancreatic fistula
|
preoperative risk model for clinically relevant postoperative pancreatic fistula by incorporation of preoperative PNI and pancreatic texture assessment by elastography with previously emerged scores in patients undergoing pancreaticoduodenectomy |
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 clinically relevant postoperative pancreatic fistula
時間枠:Within 90 days after surgery
|
Proportion of patients developing clinically relevant postoperative pancreatic fistula (Grade B or C) following pancreaticoduodenectomy, according to the International Study Group of Pancreatic Surgery (ISGPS) definition. |
Within 90 days after surgery
|
|
Discrimination of the preoperative prediction model
時間枠:Within 90 days after surgery
|
Area under the receiver operating characteristic curve (AUROC) for the preoperative prediction model in predicting clinically relevant postoperative pancreatic fistula. |
Within 90 days after surgery
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2.
- Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
- Mungroop TH, Klompmaker S, Wellner UF, Steyerberg EW, Coratti A, D'Hondt M, de Pastena M, Dokmak S, Khatkov I, Saint-Marc O, Wittel U, Abu Hilal M, Fuks D, Poves I, Keck T, Boggi U, Besselink MG; European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS). Updated Alternative Fistula Risk Score (ua-FRS) to Include Minimally Invasive Pancreatoduodenectomy: Pan-European Validation. Ann Surg. 2021 Feb 1;273(2):334-340. doi: 10.1097/SLA.0000000000003234.
- Mungroop TH, van Rijssen LB, van Klaveren D, Smits FJ, van Woerden V, Linnemann RJ, de Pastena M, Klompmaker S, Marchegiani G, Ecker BL, van Dieren S, Bonsing B, Busch OR, van Dam RM, Erdmann J, van Eijck CH, Gerhards MF, van Goor H, van der Harst E, de Hingh IH, de Jong KP, Kazemier G, Luyer M, Shamali A, Barbaro S, Armstrong T, Takhar A, Hamady Z, Klaase J, Lips DJ, Molenaar IQ, Nieuwenhuijs VB, Rupert C, van Santvoort HC, Scheepers JJ, van der Schelling GP, Bassi C, Vollmer CM, Steyerberg EW, Abu Hilal M, Groot Koerkamp B, Besselink MG; Dutch Pancreatic Cancer Group. Alternative Fistula Risk Score for Pancreatoduodenectomy (a-FRS): Design and International External Validation. Ann Surg. 2019 May;269(5):937-943. doi: 10.1097/SLA.0000000000002620.
- D'Onofrio M, Tremolada G, De Robertis R, Crosara S, Ciaravino V, Cardobi N, Marchegiani G, Pulvirenti A, Allegrini V, Salvia R, Bassi C, Pozzi Mucelli R. Prevent Pancreatic Fistula after Pancreatoduodenectomy: Possible Role of Ultrasound Elastography. Dig Surg. 2018;35(2):164-170. doi: 10.1159/000477475. Epub 2017 Jun 1.
- Marchegiani G, Ballarin R, Malleo G, Andrianello S, Allegrini V, Pulvirenti A, Paini M, Secchettin E, Boriero F, Di Benedetto F, Bassi C, Salvia R. Quantitative Assessment of Pancreatic Texture Using a Durometer: A New Tool to Predict the Risk of Developing a Postoperative Fistula. World J Surg. 2017 Nov;41(11):2876-2883. doi: 10.1007/s00268-017-4073-9.
- Wellner UF, Kayser G, Lapshyn H, Sick O, Makowiec F, Hoppner J, Hopt UT, Keck T. A simple scoring system based on clinical factors related to pancreatic texture predicts postoperative pancreatic fistula preoperatively. HPB (Oxford). 2010 Dec;12(10):696-702. doi: 10.1111/j.1477-2574.2010.00239.x.
- Zhong YQ, Zhu XX, Huang XT, Luo YJ, Huang CS, Xu QC, Yin XY. Prediction of clinically relevant postoperative pancreatic fistula after pancreatoduodenectomy based on multifrequency magnetic resonance elastography. J Gastrointest Surg. 2025 Feb;29(2):101886. doi: 10.1016/j.gassur.2024.101886. Epub 2024 Nov 13.
- Sato N, Tamura T, Minagawa N, Hirata K. Preoperative body mass index-to-prognostic nutritional index ratio predicts pancreatic fistula after pancreaticoduodenectomy. Hepatobiliary Surg Nutr. 2016 Jun;5(3):256-62. doi: 10.21037/hbsn.2015.12.08.
- Onodera T, Goseki N, Kosaki G. [Prognostic nutritional index in gastrointestinal surgery of malnourished cancer patients]. Nihon Geka Gakkai Zasshi. 1984 Sep;85(9):1001-5. Japanese.
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研究の完了 (推定)
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本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- Fistula Risk Score
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 共有サポート情報タイプ
- STUDY_PROTOCOL
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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