European Journal of Cardiovascular Medicine

Pancreaticoduodenectomy (PD), encompassing Whipple and pylorus-preserving procedures, is a cornerstone treatment for pancreatic and periampullary malignancies but carries significant morbidity, with complication rates of 30–50% in high-volume centers [1,2]. Post-pancreatectomy hemorrhage (PPH), surgical site infections (SSI), postoperative pancreatic fistula (POPF), and delayed gastric emptying (DGE) contribute to prolonged hospital stays and adverse outcomes [3,4]. In newly established Hepato-Pancreato-Biliary and Liver Transplant (HPB & LT) units, outcomes may reflect initial learning curves, limited case volumes, and evolving protocols [5].

This study evaluates PD outcomes in a newly established HPB & LT Surgery department, focusing on complications, hospital stay, and their associations with diagnosis and intraoperative factors. SSI was graded using the validated Southampton Wound Scoring System [6]. We aim to identify key morbidity drivers to guide quality improvement in nascent HPB units.

Study Design: A retrospective cohort study of 59 consecutive patients undergoing PD at the Department of HPB & LT Surgery, SMS Hospital and Medical college, Jaipur, from

Data Collection: Data were extracted from a prospectively maintained database. Variables included:

• Demographics: Sex (Male, Female), age (years).
• Surgical Details: Diagnosis (Periampullary carcinoma, Distal cholangiocarcinoma, Head of pancreas mass, IPMN, Duodenal adenocarcinoma, PNET), type of PD (Whipple, Pylorus- preserving), intraoperative blood loss (mL).

Statistical Analysis: Descriptive statistics included mean ± SD, median (IQR), and frequencies. Non-parametric tests (Mann-Whitney U, Kruskal-Wallis, Fisher’s Exact) were used for skewed data or small samples. Correlations used Pearson (continuous variables) or Spearman (ordinal variables). Significance was set at p < 0.05. Analyses were performed using R v4.3.2. Due to the single PPH case (n=1), some statistical tests (e.g., Fisher’s Exact for PPH vs. CDC class) were infeasible; descriptive comparisons were used. Outliers (e.g., blood loss 900 mL, hospital stay 25 days) were verified for clinical plausibility.

Data Integrity: All variables were verified:

• PPH: 1 case (patient 5).
• POPF: 4 cases (patients 5, 14, 40, 8).
• DGE: 22 cases (grade A: 10, 14, 17, 18, 22, 23, 26, 32, 33, 49, 50, 53, 56, 58; grade B: 19, 27, 28, 39, 40; grade C: 3, 4, 7).
• SSI grades (0–5, including 2D, 3D) conformed to the Southampton system. No missing data were identified.

Ethical Approval: Approved by [Institution IRB], reference number [XXX], with a waiver for informed consent due to retrospective design.

Patient Characteristics

Table 1A: Demographics

Table 1B: Surgical Characteristics

Postoperative Outcomes

Table 2A: Hospital Stay

Table 2B: General Complications

Table 2C: Pancreatic-Specific Complications

Table 2D: Other Complications

Table 2E: Surgical Site Infection (Southampton System)

Statistical Analysis

• PPH and Outcomes (n=1):
• Hospital Stay: PPH = Yes had a hospital stay of 25 days vs. 7.8 ± 3.3 days for PPH
• = No (n=58; Mann-Whitney U test, p = 0.017, Cohen’s d ≈ 4.7).
• Complications (CDC Class): PPH = Yes had CDC 3; PPH = No had 24.1% CDC 0, 34.5% CDC 1, 31.0% CDC 2, 10.3% CDC 3. Fisher’s Exact Test (CDC 0–1 vs. 2–3)
• was infeasible (n=1); descriptively, PPH was associated with severe complications.
• SSI: PPH = Yes had SSI grade 5; 69.0% of PPH = No had SSI (Fisher’s Exact Test, p = 1.00).
• Blood Loss: PPH = Yes had 300 mL vs. 287.1 ± 151.4 mL for PPH = No (Mann- Whitney U test, p = 0.93).
• Interpretation: PPH’s impact is significant for hospital stay but limited by n=1.
• POPF and Outcomes (n=4):
• Hospital Stay: POPF = Yes had a mean hospital stay of 11.8 ± 6.7 days (25, 8, 7, 7 days) vs. 7.8 ± 3.4 days for no POPF (n=55; Mann-Whitney U test, p = 0.045, Cohen’s d ≈ 1.0).
• Complications (CDC Class): POPF = Yes had 25% CDC 1, 25% CDC 2, 50% CDC
• 3; POPF = No had 25.5% CDC 0, 34.5% CDC 1, 30.9% CDC 2, 9.1% CDC 3
• (Fisher’s Exact Test, CDC 0–1 vs. 2–3, p = 0.12).
• DGE and Outcomes (n=22):
• Hospital Stay: DGE = Yes had a mean hospital stay of 9.8 ± 4.7 days vs. 7.1 ± 2.6 days for no DGE (n=37; Mann-Whitney U test, p = 0.001, Cohen’s d ≈ 0.7).
• Complications (CDC Class): DGE = Yes had 13.6% CDC 0, 27.3% CDC 1, 36.4%
• CDC 2, 22.7% CDC 3; DGE = No had 29.7% CDC 0, 37.8% CDC 1, 27.0% CDC 2,
• 4% CDC 3 (Fisher’s Exact Test, CDC 0–1 vs. 2–3, p = 0.04).
• Diagnosis and Outcomes:
• Hospital Stay: IPMN (10.2 ± 3.3 days) and head of pancreas mass (9.5 ± 4.8 days) trended toward longer stays vs. periampullary carcinoma (7.8 ± 4.3 days), distal cholangiocarcinoma (7.6 ± 1.7 days), duodenal adenocarcinoma (6.0 ± 0.0 days), and PNET (7.8 ± 1.2 days; Kruskal-Wallis test, p = 0.34).
• Complications (CDC Class): Head of pancreas mass (37.5% CDC 3) and IPMN (20.0% CDC 3) had higher severe complication rates vs. periampullary carcinoma (12.1% CDC 3; Chi-square test, CDC 0–1 vs. 2–3, p = 0.08).
• PPH: Exclusive to periampullary carcinoma (1/33, 3.0%; Fisher’s Exact Test, p = 1.00).
• POPF: 2/33 periampullary carcinoma (6.1%), 1/8 head of pancreas mass (12.5%), 1/5 IPMN (20.0%) (Fisher’s Exact Test, p = 0.71).
• DGE: 13/33 periampullary carcinoma (39.4%), 3/8 head of pancreas mass (37.5%), 2/5 IPMN (40.0%), 1/5 distal cholangiocarcinoma (20.0%), 1/2 duodenal adenocarcinoma (50.0%), 2/6 PNET (33.3%) (Fisher’s Exact Test, p = 0.97).

SSI and Outcomes:

• Presence: SSI present (n=42) had a mean hospital stay of 9.0 ± 4.1 days vs. 6.1 ± 1.9 days for SSI absent (n=17; Mann-Whitney U test, p = 0.002, Cohen’s d ≈ 0.9).
• Severity: Ordinalized SSI grades (0 = 0, 1A–1C = 1, 2A–2D = 2, 3A–3D = 3, 4A– 4B = 4, 5 = 5) correlated with hospital stay (Spearman ρ = 0.60, p < 0.001) and CDC class (ρ = 0.68, p < 0.001).
• Other Relationships:
• Blood Loss: Correlated with hospital stay (Pearson r = 0.35, p = 0.007).
• Age: Weakly correlated with hospital stay (r = 0.28, p = 0.03) but not CDC class (ρ = 0.22, p = 0.09).

Figures

Figure 1: Hospital Stay by SSI and DGE Status

Caption: Figure 1. Mean hospital stay for patients with surgical site infection (SSI, n=42) vs. without (n=17), and with delayed gastric emptying (DGE, n=22) vs. without (n=37). SSI (p = 0.002) and DGE (p = 0.001) significantly prolong hospital stay (Mann-Whitney U test).

Figure 2: SSI Grade Distribution by Clavien-Dindo Class

Caption: Figure 2. Distribution of surgical site infection (SSI) grades (Southampton system) across Clavien-Dindo classes. Major SSI grades (3A–5) are strongly associated with higher Clavien-Dindo classes (ρ = 0.68, p < 0.001, Spearman correlation).

Figure 3: Hospital Stay by Diagnosis

Caption: Figure 3. Mean hospital stay by diagnosis. IPMN and head of pancreas mass trend toward longer stays, though differences are not significant (p = 0.34, Kruskal-Wallis test).

This study provides a comprehensive evaluation of PD outcomes in a newly established HPB & LT Surgery unit. The PPH rate (1.7%, n=1) is lower than meta-analyses reporting 5–10% [1,3], but its significant impact on hospital stay (25 days vs. 7.8 days, p = 0.017) underscores its clinical importance. The single PPH case (patient 5) had high-grade SSI (grade 5), POPF (grade C), DGE (grade C), and CDC class 3, suggesting a synergy among severe complications, though the small sample limits statistical power [4].

The DGE rate (37.3%, n=22) is higher than typical ranges (10–20%) [9], likely reflecting the sensitivity of ISGPS grading in capturing mild cases (23.7% grade A). DGE significantly prolonged hospital stay (p = 0.001) and was associated with severe complications (p = 0.04), highlighting its role as a major morbidity driver. The SSI rate (71.2%) exceeds reported ranges (20–40%) [2,10], likely due to the Southampton system’s sensitivity in capturing minor wound changes (e.g., 1A–1C) [6]. SSI severity strongly correlated with hospital stay (ρ = 0.60, p < 0.001) and CDC class (ρ = 0.68, p < 0.001). POPF (6.8%) also prolonged hospital stay (p = 0.045), consistent with ISGPS definitions [8].

Head of pancreas mass and IPMN trended toward higher CDC class 3 rates (p = 0.08), likely due to complex resections [11]. PPH and POPF were most prevalent in periampullary carcinoma and IPMN, possibly reflecting anatomical challenges [3]. DGE was distributed across diagnoses without significant differences (p = 0.97). Blood loss correlated with hospital stay (r = 0.35, p = 0.007), emphasizing meticulous hemostasis [12].

In a new HPB unit, the overall complication rate (76.3%) is within expected ranges, but high SSI and DGE rates suggest opportunities for enhanced infection control and perioperative optimization [2]. Strategies such as standardized antibiotic prophylaxis, advanced wound care, and vigilant monitoring for DGE, POPF, and PPH are critical. Tailored approaches for high-risk diagnoses (e.g., IPMN) may reduce morbidity.

Limitations: The single PPH case (n=1) and small POPF sample (n=4) limited statistical power. Single-center data may not generalize, and the retrospective design risks selection bias. The high SSI and DGE rates may partly reflect the sensitivity of the Southampton and ISGPS grading systems.

Future Directions: Multicenter studies and prospective data collection could validate these findings. Enhanced recovery protocols, nutritional optimization for DGE, and advanced hemostatic techniques may improve outcomes.

In a newly established HPB & LT Surgery unit in a public sector hospital, SSI and DGE are primary drivers of prolonged hospital stays and severe complications following PD, with POPF and PPH contributing significantly despite lower incidence. Robust infection control, nutritional support for DGE, vigilant monitoring for POPF and PPH, and tailored strategies for high-risk diagnoses are essential to improve outcomes. These findings provide a benchmark for nascent HPB units and highlight critical areas for quality enhancement.

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