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
研究概览
详细说明
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
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Hisham Ali Riad Shaban Ali Riad Hisham Ali Riad Shaban, Professor of General Surgery
- 电话号码:01005015757
- 邮箱:heshamreyad@aun.edu.eg
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients undergoing elective pancreaticoduodenctomy
描述
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.
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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 |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of clinically relevant postoperative pancreatic fistula
大体时间: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
|
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Discrimination of the preoperative prediction model
大体时间: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
|
合作者和调查者
出版物和有用的链接
一般刊物
- 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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