Sponsor study identifier
observational
150
1 country
1
Study Start
April 1, 2026
Actual (reported)Primary Completion
April 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The primary aim of the study is to identify clinical, laboratory, imaging, and pathohistological risk factors for the development of pancreatogenic diabetes after partial resection of the pancreas (PRP) and, based on these, to build a predictive model that would enable reliable and accurate identification of patients who will develop pancreatogenic diabetes. A review of the literature shows that there is currently no validated tool available in clinical practice for identifying patients at risk of this type of diabetes after PRP. Etiological differences between type 2 diabetes and pancreatogenic diabetes often lead to late diagnosis, limiting opportunities for timely intervention. The development of a comprehensive predictive model would contribute to a better understanding of the pathophysiology of pancreatogenic diabetes, enable the identification of patients at risk, facilitate tailored clinical monitoring, and allow the implementation of targeted preventive or therapeutic measures in the perioperative period. Based on a review of the literature and clinical observations, the investigators formulated the following hypotheses: H1: Clinical, laboratory, imaging, and pathohistological variables are independently associated with the development of pancreatogenic diabetes after partial pancreatic resection. H2: A predictive model that allows reliable and accurate identification of patients who will develop pancreatogenic diabetes can be build based on the identified variables (H1). H3: A comprehensive predictive model in the perioperative period allows more precise identification of patients who will develop pancreatogenic diabetes, and thus more effective risk stratification compared to the use of individual risk factors (variables). Based on the reviewed literature and our own clinical observations, this constitutes an original contribution to science. The investigators expect that the research will identify key clinical, laboratory, imaging, and pathohistological factors associated with the development of pancreatogenic diabetes after partial pancreatic resection. The development of a clinically useful predictive model that will allow individual risk assessment for the development of pancreatogenic diabetes in patients after partial pancreatic resection is anticipated. A similar comprehensive model has not yet been described in the accessible literature. The research will contribute to a better understanding of metabolic changes and will enable the identification of patients who will develop pancreatogenic diabetes after partial pancreatic resection. The results of the study could provide a basis for improved perioperative monitoring of these patients in the field of pancreatogenic diabetes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2026
Actual (reported)June 9, 2026
Actual (reported)June 24, 2026
Actual (reported)April 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Development of pancreatogenic diabetes
Pancreatogenic diabetes will be assessed based on standard diagnostic criteria using oral glucose tolerance test.
3 months after surgery
Insulin Resistance
Baseline to 3 months after surgery
Beta Cell Function
Baseline to 3 months after surgery
Prediction Model Performance
At 3 months after surgery
Patohistology of the Pancreas
immediately after the resection of the pancreas
CT of the abdomen
before the resection of the pancreas and 3 months after the resection
This cohort includes adult patients undergoing partial pancreatectomy for various pancreatic diseases. Inclusion criteria: age ≥ 18 years, planned partial resection of the pancreas, absence of known diabetes mellitus, borderline basal glycemia, or impaired glucose tolerance before the procedure, signed written informed consent. Criteria for non-inclusion: known diabetes, borderline basal glycemia or impaired glucose tolerance before surgery (even if confirmed by OGTT before the procedure), inability to provide informed consent. Participants are prospectively followed to assess metabolic changes and the development of pancreatogenic diabetes. No experimental interventions are administered as part of the study; all patients receive standard clinical care. Data collection includes clinical, biochemical, imaging, and histopathological parameters.
Adult patients undergoing partial pancreatectomy for pancreatic diseases at a tertiary care center, which correspond to inclusion and exclusion criteria.
University Medical Centre Ljubljana
Ljubljana, 1000, Slovenia
Lundberg S, Lee SI. A Unified Approach to Interpreting Model Predictions [Internet]. arXiv; 2017 [citirano 8. marec 2026]. Dostopno na: https://arxiv.org/abs/1705.07874 doi:10.48550/ARXIV.1705.07874
Collins GS, Moons KGM, Dhiman P, Riley RD, Beam AL, Van Calster B, Ghassemi M, Liu X, Reitsma JB, van Smeden M, Boulesteix AL, Camaradou JC, Celi LA, Denaxas S, Denniston AK, Glocker B, Golub RM, Harvey H, Heinze G, Hoffman MM, Kengne AP, Lam E, Lee N, Loder EW, Maier-Hein L, Mateen BA, McCradden MD, Oakden-Rayner L, Ordish J, Parnell R, Rose S, Singh K, Wynants L, Logullo P. TRIPOD+AI statement: updated guidance for reporting clinical prediction models that use regression or machine learning methods. BMJ. 2024 Apr 16;385:e078378. doi: 10.1136/bmj-2023-078378.
Imamura S, Niwano F, Babaya N, Hiromine Y, Matsumoto I, Kamei K, Yoshida Y, Taketomo Y, Yoshida S, Takeyama Y, Noso S, Maeda N, Ikegami H. High Incidence of Diabetes Mellitus After Distal Pancreatectomy and Its Predictors: A Long-term Follow-up Study. J Clin Endocrinol Metab. 2024 Feb 20;109(3):619-630. doi: 10.1210/clinem/dgad634.
Jasna Klen, MD, PhD, Prof.
Ljubljana University Medical Centre, Zaloška cesta 7, Ljubljana
First Submitted
June 9, 2026
First Posted
June 24, 2026
Study Start
April 1, 2026
Actual (reported)Primary Completion
April 1, 2029
EstimatedContact the study team to confirm eligibility.
Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract available.
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Jones AG, Hattersley AT. The clinical utility of C-peptide measurement in the care of patients with diabetes. Diabet Med. 2013 Jul;30(7):803-17. doi: 10.1111/dme.12159.
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Shirakawa S, Matsumoto I, Toyama H, Shinzeki M, Ajiki T, Fukumoto T, Ku Y. Pancreatic volumetric assessment as a predictor of new-onset diabetes following distal pancreatectomy. J Gastrointest Surg. 2012 Dec;16(12):2212-9. doi: 10.1007/s11605-012-2039-7. Epub 2012 Sep 28.
Wu L, Nahm CB, Jamieson NB, Samra J, Clifton-Bligh R, Mittal A, Tsang V. Risk factors for development of diabetes mellitus (Type 3c) after partial pancreatectomy: A systematic review. Clin Endocrinol (Oxf). 2020 May;92(5):396-406. doi: 10.1111/cen.14168. Epub 2020 Feb 18.
Almeida RR, Lo GC, Patino M, Bizzo B, Canellas R, Sahani DV. Advances in Pancreatic CT Imaging. AJR Am J Roentgenol. 2018 Jul;211(1):52-66. doi: 10.2214/AJR.17.18665. Epub 2018 Apr 9.
Sofue K, Ueshima E, Masuda A, Shirakawa S, Zen Y, Ueno Y, Tsujita Y, Yamaguchi T, Yabe S, Tanaka T, Inomata N, Toyama H, Fukumoto T, Kodama Y, Murakami T. Estimation of pancreatic fibrosis and prediction of postoperative pancreatic fistula using extracellular volume fraction in multiphasic contrast-enhanced CT. Eur Radiol. 2022 Mar;32(3):1770-1780. doi: 10.1007/s00330-021-08255-4. Epub 2021 Oct 12.
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Strobel O, Buchler MW, Werner J. Surgical therapy of chronic pancreatitis: indications, techniques and results. Int J Surg. 2009 Aug;7(4):305-12. doi: 10.1016/j.ijsu.2009.05.011. Epub 2009 Jun 6.
Petrov MS, Taylor R. Intra-pancreatic fat deposition: bringing hidden fat to the fore. Nat Rev Gastroenterol Hepatol. 2022 Mar;19(3):153-168. doi: 10.1038/s41575-021-00551-0. Epub 2021 Dec 8.
Fukui H, Onishi H, Ota T, Nakamoto A, Tsuboyama T, Enchi Y, Yamada D, Takeda Y, Kobayashi S, Fukuda Y, Eguchi H, Matsui T, Tatsumi M, Tomiyama N. Pancreatic fibrosis assessment and association with pancreatic cancer: comparison with the extracellular volume fraction. Clin Radiol. 2024 Nov;79(11):e1356-e1365. doi: 10.1016/j.crad.2024.08.007. Epub 2024 Aug 12.
Kattner N, Bashir A, Shaw JAM. The emerging role of pancreatic exocrine fibrosis as a common aetiological driver of islet dysfunction and diabetes: opportunities for novel disease-modifying interventions. Diabetologia. 2026 May;69(5):1118-1132. doi: 10.1007/s00125-026-06678-6. Epub 2026 Feb 10.
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ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S19-S40. doi: 10.2337/dc23-S002.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 16, 2026
Record last verified: 2026-07
De-identified IPD will include demographic and clinical baseline data, perioperative surgical variables, metabolic and laboratory parameters (including glucose, HbA1c, insulin, C-peptide, OGTT-derived indices such as HOMA-IR), selected imaging-derived variables, histopathological findings of pancreatic tissue, and 3-month postoperative outcomes including diagnosis of pancreatogenic diabetes.
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Source: ClinicalTrials.gov.
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