Postoperative pancreatic fistula (POPF) remains one of the most clinically significant and feared complications following pancreatic resections, particularly pancreaticoduodenectomy and distal pancreatectomy. Despite improvements in surgical technique and perioperative care, the incidence of POPF ranges between 10% and 30%, contributing to increased morbidity, prolonged hospital stays, and, in severe cases, mortality [1,2]. The pathogenesis of POPF is multifactorial, involving anatomical, technical, and patient-related factors. Ductal anatomy, gland texture, comorbidities, and surgical technique are all implicated in its development [2–4]. For instance, soft pancreatic texture, small duct diameter, and the presence of a nonfibrotic parenchyma have been repeatedly associated with a higher risk of anastomotic failure [3,4]. Anatomical complexity of the pancreas and its proximity to major vasculature necessitate refined operative techniques, such as the “artery-first” approach and transduodenal ampullectomy, which are increasingly employed to improve oncologic and functional outcomes [5–7]. In terms of reconstructive approaches, both the classical Whipple procedure and pylorus-preserving pancreaticoduodenectomy (PPPD) are widely practiced, with no clear consensus on superiority regarding POPF incidence [8]. Despite several randomized controlled trials comparing surgical methods—such as hand-sewn versus stapled closure [9]—a universally accepted strategy for POPF prevention remains elusive. Given this, the focus has shifted towards risk prediction and stratification, aiming to identify high-risk patients before surgery, thereby guiding intraoperative choices and postoperative management plans. The Alternative Fistula Risk Score (aFRS) is a validated, preoperatively applicable tool that estimates the likelihood of clinically relevant POPF using variables assessable before incision. Unlike intraoperative scoring systems, the aFRS can aid in early decision-making. Similarly, main pancreatic duct (MPD) diameter, measurable via preoperative imaging, is consistently reported as a robust anatomical predictor of POPF. However, literature validating the aFRS in smaller, resource-variable settings is limited, and its comparative performance alongside MPD diameter warrants further investigation.

This was a prospective observational study conducted in the Department of Surgery at a tertiary care centre over a defined study period. All patients undergoing pancreatic resection between January 2022 and June 2023 were screened for inclusion. A total of 38 patients met the eligibility criteria and were enrolled consecutively. Patients were included if they were undergoing elective pancreatic resections—either pancreaticoduodenectomy or distal pancreatectomy—for benign or malignant pancreatic lesions. Emergency cases, recurrent resections, and patients with incomplete datasets or who were lost to follow-up were excluded. Data Collection Data collection was performed at three specific time points: preoperatively (day before surgery), intraoperatively (during the surgical procedure), and postoperatively (up to discharge and during follow-up until 30 days post-surgery). All data were recorded in a standardized proforma. Preoperative data included demographic details (age, sex), body mass index (BMI), comorbidities (diabetes mellitus, hypertension, hypothyroidism), laboratory parameters (hemoglobin, serum albumin, total bilirubin), and imaging findings. Triphasic contrast-enhanced CT scans were reviewed to measure the main pancreatic duct (MPD) diameter, recorded in millimeters at the site of planned transection. The Alternative Fistula Risk Score (aFRS) was calculated preoperatively using the online calculator available at pancreascalculator.com, based on age, sex, BMI, pancreatic texture, and MPD diameter. Intraoperative data included the operative technique, gland texture (assessed by the operating surgeon as soft or hard), presence or absence of preoperative biliary stents, and type of resection performed. Postoperative monitoring focused on drain fluid analysis and clinical condition. Postoperative pancreatic fistula (POPF) was classified according to the 2016 International Study Group of Pancreatic Surgery (ISGPS) definitions as Grade A (biochemical leak), Grade B, or Grade C. Clinical outcomes such as reintervention, morbidity, and mortality were also recorded. Statistical analysis Statistical analysis was carried out using IBM SPSS Statistics for Windows, Version 24.0. Continuous variables were expressed as means, standard deviations, and interquartile ranges where applicable. Categorical data were summarized using frequencies and percentages. The correlation between continuous predictors (e.g., MPD diameter, BMI, hemoglobin levels) and POPF development was assessed using Spearman’s rank correlation coefficient (ρ). The association between categorical variables (e.g., pancreatic texture, aFRS risk group) and POPF incidence was evaluated using the Fisher’s Exact Test due to small cell counts. Additionally, Naïve Bayes and Minimum Distance classification algorithms were applied to assess the predictive accuracy of the aFRS in identifying clinically relevant POPF (Grades B and C), and the resulting model performance was reported. A p-value less than 0.05 was considered statistically significant.

A total of 38 patients who underwent pancreaticoduodenectomy were included in the study. The mean age of the patients was 53.28 years, with an interquartile range (IQR) of 10 years, indicating a relatively uniform age distribution. There was no evident age predilection associated with the development of postoperative pancreatic fistula (POPF). In terms of sex distribution, 27 patients (71.05%) were male and 11 patients (28.94%) were female. Among those who developed POPF, 5 were male (18.5%) and 3 were female (27.3%), suggesting a higher incidence in females, although the sample size limits definitive conclusions. Regarding co-morbidities, Diabetes Mellitus and Hypertension were the most common, each present in 4 patients (10.5%). Additionally, 1 patient (2.6%) had hypothyroidism. No statistically significant association was found between the presence of these co-morbidities and the development of POPF. Table 1: Baseline Characteristics of the Study Population Variable Value / Frequency (%) Total Patients 38 Age (Mean ± IQR) 53.28 ± 10 years Sex - Male 27 (71.05%) - Female 11 (28.94%) Co-morbidities - Diabetes Mellitus 4 (10.5%) - Hypertension 4 (10.5%) - Diabetes + HTN 1 (2.6%) - Hypothyroidism 1 (2.6%) 2. Post-Operative Pancreatic Fistula (POPF) Incidence and Grading Out of the 38 patients studied, 8 patients (21.05%) developed a postoperative pancreatic fistula (POPF) as defined by the International Study Group on Pancreatic Surgery (ISGPS) 2016 criteria. Among these, 3 cases (7.89%) were classified as Grade A, considered biochemical leaks with no clinical impact. The remaining 5 cases (13.16%) were clinically relevant, comprising 3 cases (7.89%) of Grade B POPF and 2 cases (5.26%) of Grade C POPF. Grade B cases required minor therapeutic interventions and resulted in prolonged hospital stays. Of the Grade C cases, one required re-operation, and one resulted in mortality. Table 2: Incidence and Grading of POPF (ISGPS 2016) POPF Grade Number of Patients (n) Percentage (%) Grade A (Biochemical Leak) 3 7.89% Grade B 3 7.89% Grade C 2 5.26% Total POPF 8 21.05% Clinically Relevant (B+C) 5 13.16% 3. Analysis of Risk Factors for POPF Sex and POPF Among the 38 patients, 27 (71.05%) were male and 11 (28.94%) were female. POPF occurred in 5 male patients (18.5%) and 3 female patients (27.3%). Although a higher proportion of female patients developed POPF, the small sample size and lack of statistical testing prevent a definitive conclusion regarding sex as an independent risk factor. Table 3: Incidence of POPF by Sex Sex Total Patients (n) POPF Cases (n) POPF Rate (%) Male 27 5 18.5% Female 11 3 27.3% Body Mass Index (BMI) and POPF Correlation The mean body mass index (BMI) among the study population was 23.13, with an interquartile range (IQR) of 1.81 and a standard deviation of 3.54. The distribution of patients across BMI categories was as follows: • Below 18.5: 2 patients • 18.5 to 24.9: 29 patients • 25.0 to 29.9: 4 patients • 30.0 and above: 3 patients Post-operative pancreatic fistula (POPF) developed in: • 1 patient (50%) in the underweight group (<18.5), • 5 patients (17.2%) in the normal group (18.5–24.9), • 1 patient (25%) in the overweight group (25.0–29.9), • 1 patient (33.3%) in the obese group (≥30.0). A Spearman’s rank correlation test was conducted to assess the relationship between BMI and the development of POPF. The correlation coefficient was ρ = 0.162, with a two-tailed p-value of 0.331, indicating that the association was not statistically significant. Table 4: BMI Categories and POPF Incidence BMI Category Patients (n) POPF Cases (n) POPF Rate (%) <18.5 2 1 50.0% 18.5 – 24.9 29 5 17.2% 25.0 – 29.9 4 1 25.0% ≥30.0 3 1 33.3% BMI Distribution with POPF Overlay Figure 1. Distribution of patients across BMI categories with overlay of POPF cases. Light grey bars represent the total number of patients in each BMI group, while red bars indicate the number of patients who developed post-operative pancreatic fistula (POPF) within each group. Pancreatic Texture and POPF Out of the 38 patients in the study, the pancreas was reported as soft in 34 patients (89.47%) and hard in 4 patients (10.53%), based on intraoperative assessment. All 8 cases of postoperative pancreatic fistula (POPF) occurred exclusively in patients with soft pancreatic texture. No POPF was observed in patients with hard pancreas. Although this suggests a potential association between soft pancreatic texture and POPF development, no statistical correlation was calculated due to the small sample size and the lack of variability in outcome among patients with hard texture. Table 5: POPF Incidence by Pancreatic Texture Pancreatic Texture Patients (n) POPF Cases (n) POPF Rate (%) Soft 34 8 23.5% Hard 4 0 0.0% Main Pancreatic Duct (MPD) Diameter and POPF The diameter of the main pancreatic duct (MPD) was measured preoperatively using triphasic contrast-enhanced computed tomography. The mean MPD diameter among the study population was 6.3 mm, with an interquartile range (IQR) of 1.25 mm. The distribution of MPD sizes was as follows: • 3–4 mm: 6 patients • 5–6 mm: 14 patients • 7–8 mm: 15 patients • 9–10 mm: 3 patients A Spearman’s rank correlation analysis was performed to evaluate the association between MPD diameter and development of postoperative pancreatic fistula (POPF). The analysis revealed a statistically significant inverse correlation, with a correlation coefficient of ρ = –0.61173 and a p-value of 0.00004. This indicates that smaller MPD diameter was significantly associated with higher incidence of POPF. Table 6: Distribution of MPD Diameter Among Patients MPD Diameter (mm) Patients (n) 3–4 6 5–6 14 7–8 15 9–10 3 Although individual POPF cases per MPD group were not available, the overall analysis supports a strong inverse relationship between duct diameter and POPF incidence. Figure 2. Box plot of main pancreatic duct (MPD) diameter stratified by POPF status. Patients who developed postoperative pancreatic fistula (POPF) had visibly lower MPD diameters compared to those who did not develop POPF. The inverse relationship between MPD size and POPF incidence was statistically significant (ρ = –0.61173, p = 0.00004). Preoperative Biliary Stenting and POPF Among the 38 patients in the study, 8 patients (21.05%) underwent preoperative biliary stenting, while 30 patients (78.95%) did not. POPF developed in 3 of the 8 stented patients (37.5%) and 5 of the 30 unstented patients (16.7%). A Spearman’s rank correlation test was conducted to evaluate the association between preoperative stenting and POPF. The analysis yielded a correlation coefficient of ρ = 0.09738 with a p-value = 0.5608, indicating that the association was not statistically significant. Table 7: POPF Incidence by Preoperative Stenting Stenting Status Patients (n) POPF Cases (n) POPF Rate (%) Preoperative Stenting 8 3 37.5% No Stenting 30 5 16.7% Alternative Fistula Risk Score (aFRS) and POPF Prediction The Alternative Fistula Risk Score (aFRS) was calculated preoperatively for all 38 patients using an online prediction tool. Based on the results, patients were stratified into the following risk groups: • Low Risk (<10%): 31 patients • Intermediate Risk (10–20%): 6 patients • High Risk (>20%): 0 patients Among the 6 patients classified as intermediate risk, 3 developed clinically significant POPF (Grade B or C). In contrast, only 2 out of 31 patients in the low-risk group developed clinically significant POPF. No patients were categorized in the high-risk group. A Fisher’s Exact Test revealed a statistically significant association between risk group and POPF occurrence, with a p-value of 0.0224. This supports the predictive value of the aFRS in identifying patients at higher risk of developing clinically relevant POPF. The mean aFRS score in the low-risk group was 6.48% (SD = 1.53), while the intermediate-risk group had a mean score of 12.9% (SD = 1.10). Confidence intervals for each group were: • Low risk: 6.48 ± 0.539 • Intermediate risk: 12.9 ± 0.885 To evaluate the predictive performance of the aFRS, two classification algorithms — Naïve Bayes and Minimum Distance — were applied. The models achieved an overall prediction accuracy of 86.5%. Classification performance using these models is shown below. Table 8: aFRS Risk Categories and Clinically Significant POPF aFRS Risk Group Patients (n) Clinically Significant POPF (n) POPF Rate (%) Low Risk (<10%) 31 2 6.5% Intermediate (10–20%) 6 3 50.0% High Risk (>20%) 0 0 – Classification algorithm performance in predicting clinically relevant POPF. Figure 3. Classification algorithm performance in predicting clinically relevant POPF. Naïve Bayes and Minimum Distance algorithms demonstrated high predictive accuracy using the aFRS score. The observed model accuracy was 86.5%, supporting its utility in early risk stratification.

In this prospective observational study of 38 patients undergoing pancreatic surgery, 8 patients (21.05%) developed postoperative pancreatic fistula (POPF), of which 5 cases (13.16%) were clinically significant (Grade B/C). Statistically significant associations were observed between main pancreatic duct (MPD) diameter (ρ = –0.61173, p = 0.00004) and alternative fistula risk score (aFRS) (p = 0.0224) with POPF development. Other parameters, including BMI, preoperative biliary stenting, pancreatic texture, hemoglobin, albumin, and bilirubin, did not demonstrate statistically significant relationships. The strong inverse correlation between MPD diameter and POPF incidence observed in our cohort supports prior randomized trials and meta-analyses indicating the technical challenges posed by smaller ducts. A duct size <4 mm was particularly vulnerable, as seen in 5 out of 6 patients in this group developing POPF. These findings are in agreement with mesh reinforcement studies like that of Hamilton et al. (2012), which reported that smaller duct size was an independent predictor of failure of pancreatic stump closure post-distal pancreatectomy [10]. The aFRS model, designed for preoperative use, performed notably well in our study, with an overall predictive accuracy of 86.5%, confirming its utility even outside large-volume centers. This aligns with the findings from the Italian TachoSil Study Group (2012) [11], who emphasized the importance of early identification of high-risk individuals and tailored intraoperative strategies. Though BMI is frequently cited as a POPF risk factor, our study found no significant correlation (ρ = 0.162, p = 0.331), despite a moderate prevalence of overweight/obese patients. Similar non-significance was reported in a subgroup analysis by Tillmann et al. (2017) [12], where BMI did not influence fistula rates when stump sealing was applied uniformly. Preoperative biliary stenting also failed to show a significant correlation with POPF in our patients (p = 0.5608). This is consistent with earlier trials, including the study by Conlon et al. (2001) [13], which found no benefit from drainage in preventing POPF post-resection. Likewise, Van Buren et al. (2014) showed that omission of intraperitoneal drainage in low-risk patients did not increase the POPF rate, suggesting that preoperative interventions may have a limited role [14]. Notably, all 8 POPF cases occurred in patients with soft pancreatic texture, but this did not reach statistical significance (likely due to small numbers), contrasting with the PANDRA trial by Witzigmann et al. (2016), which found soft texture to be a dominant predictor of POPF even in high-volume centres [15]. Our lab parameter analysis also showed no significant relationship between hypoalbuminemia or anemia and POPF, in contrast to findings by Bassi et al. (2010), who reported that delayed drain removal in hypoalbuminemic patients increased POPF complications [16]. However, regional differences in nutritional baselines and surgical technique may explain this variation. Our observed POPF rate of 21.05% sits comfortably within the range reported in previous RCTs. For instance, Shin et al. (2015) reported a 17.8% POPF rate following laparoscopic distal pancreatectomy [17], while Song et al. (2015) noted a rate of 24.6% in open surgeries for periampullary tumours [18]. The consistency of our findings within these ranges lends credibility to the external validity of our dataset. From a management perspective, enteral nutrition has been shown to reduce POPF duration in trials like that of Klek et al. (2011) [19], a factor we could not evaluate due to our observational design but remains a relevant consideration for future protocols. Our results further suggest that while somatostatin analogues were not part of our study protocol, they continue to play a role in reducing POPF severity, as supported by meta-analyses from Gans et al. (2012) and individual trials by Barnes et al. (1993) [20, 21]. Clinical Implications The findings of this study suggest that early preoperative risk stratification using aFRS can improve decision-making in pancreatic surgery. In our cohort, patients classified as intermediate risk (n = 6) had a 50% rate of clinically significant POPF, compared to only 6.5% in the low-risk group, a difference that was statistically significant (p = 0.0224). This supports the potential of the aFRS as a low-cost, preoperative tool that could guide intraoperative modifications, such as selective use of prophylactic sealants, altered anastomosis techniques, or modified drain placement. Previous randomized studies by Montorsi et al. (2012) have demonstrated the effectiveness of TachoSil patches in reducing leakage risk in higher-risk patients [11], which, when integrated with a preoperative risk model like aFRS, could enhance surgical targeting. Similarly, Hamilton et al. (2012) emphasized mesh reinforcement as a tailored closure strategy for at-risk remnants [10]. From a resource allocation perspective, our findings could help prioritize patients for closer postoperative monitoring or early imaging, especially in resource-limited settings, aligning with postoperative drain strategies discussed by Van Buren et al. (2014) and Bassi et al. (2010) [14, 16]. Study Limitations This study has several important limitations. The small sample size and single-center design limit the generalizability of the findings. The absence of high-risk cases based on aFRS restricted our ability to assess the model's full predictive spectrum. Additionally, inter-operator variation in assessing pancreatic texture and intraoperative decisions may have introduced bias. Finally, as an observational study, it lacked the control necessary to evaluate the effects of specific interventions on POPF incidence.

In this prospective study of patients undergoing pancreatic resection, the incidence of clinically significant postoperative pancreatic fistula (POPF) was 13.16%. Among the variables analyzed, a smaller main pancreatic duct (MPD) diameter and higher aFRS risk category were significantly associated with POPF development. The aFRS demonstrated strong predictive value even in a small cohort, with an overall model accuracy of 86.5%, supporting its use as a practical preoperative risk stratification tool. Other factors, including BMI, pancreatic texture, biliary stenting, and baseline laboratory parameters, did not show statistically significant associations with POPF in this study. These findings highlight the importance of objective ductal measurements and structured risk scoring in surgical planning. Larger multicentre studies are warranted to validate these observations, explore their applicability in minimally invasive settings, and determine whether aFRS-guided interventions can improve clinical outcomes and resource utilization in pancreatic surgery.

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