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MALE SEX IS ASSOCIATED WITH WORSE OUTCOMES IN ACUTE PANCREATITIS: POST-HOC ANALYSIS OF THE WATERLAND RANDOMIZED TRIAL

Lucía Guilabert 1, Lorena Bernal 1, Alejandra Sánchez-Peydró 1, Karina Cárdenas-Jaén 1, Alicia Vaillo-Rocamora 1, Enrique de-Madaria 1,2,3

Affiliations

1 Dr. Balmis General University Hospital, ISABIAL, Alicante, Alicante, Spain

2 Miguel Hernández University, Elche, Spain

3 Centro de Investigación Biomédica en red en Enfermedades Hepáticas y Digestivas(CIBERehd), Madrid, Spain

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Abstract

Introduction

Acute pancreatitis (AP) has a wide clinical spectrum, from mild, self-limited disease to severe illness with organ failure and death. Biological sex may influence body composition, inflammatory responses, and clinical outcomes, but data in AP are limited. We aimed to assess the association between sex and outcomes in patients enrolled in the WATERLAND randomized trial of moderate fluid therapy.

Aims & Methods

We conducted a post hoc analysis of WATERLAND, an international randomized trial comparing moderate fluid therapy with lactated Ringer’s (LR) versus normal saline (NS) in AP. The primary aim was to evaluate the association between sex and moderately severe or severe AP (Revised Atlanta classification). Secondary aims included the association between sex and hypovolemia at 48 hours, systemic inflammatory response syndrome (SIRS), organ failure, local complications, and mortality. We used multivariable logistic regression adjusted for etiology, body mass index (BMI), age and comorbidity (Charlson score), baseline severity (BISAP), and treatment arm (LR vs NS).

Results

We analyzed 788 patients, 380 (48.2%) men and 408 (51.8%) women. Moderately severe or severe AP occurred in 74/408 (18.1%) women and 110/380 (28.9%) men. At enrollment, men less often had gallstone etiology and more frequently had alcohol-related AP, and showed higher urea, hematocrit, and creatinine levels, as well as more hypovolemia and SIRS. In adjusted analyses, male sex was independently associated with an increased risk of moderately severe or severe AP (adjusted odds ratio [aOR] 1.72, 95% confidence interval [CI] 1.22–2.42). Male sex was also associated with a higher risk of hypovolemia and SIRS at 48 hours, kidney, cardiovascular, and respiratory failure, persistent organ failure, and local complications, including infected pancreatic necrosis. Despite this, women had greater symptom intensity than men, as measured by the PAN-PROMISE score a validated patiente reported outcome measurement. Associations with fluid overload, necrotizing pancreatitis and mortality were not statistically significant.

Table 1. Outcomes distinguished by sex

Outcome	Women (n = 408)	Men (n = 380)	Adjusted OR (95% CI)
Hypovolemia at 48h	62 (15.2%)	102 (26.8%)	2.04 (1.42-2.92)
SIRS at 48h	43 (10.7%)	71 (18.8%)	1.78 (1.16-2.71)
Kidney failure	6 (1.5%)	24 (6.3%)	4.02 (1.66-10.63)
Cardiovascular failure	6 (1.5%)	19 (5%)	3.23 (1.25-8.32)
Respiratory failure	22 (5.4%)	39 (10.3%)	1.92 (1.10-3.35)
Persistent organ failure	13 (3.2%)	31 (8.2%)	2.58 (1.31-5.10)
Moderately severe or severe disease	74 (18.1%)	110 (28.9%)	1.72 (1.22-2.42)
Any local complication	59 (14.5%)	81 (21.3%)	1.49 (1.02-2.17)
Infection of pancreatic necrosis	1 (0.2%)	12 (3.2%)	11.92 (1.51-93.83)

CI: confidence interval. OR: odds ratio. Adjusted odds ratio: adjusted by etiology, body mass index (BMI), age + comorbidity (Charlson score), baseline severity prediction (BISAP), and treatment arm (LR vs. NS).

Conclusion

In this post hoc analysis of the WATERLAND randomized trial, male sex was independently associated with more severe disease and a higher burden of organ failure and local complications in AP although they were less symptomatic than women according to PANPROMISE score. Sex should be considered an important prognostic factor and a variable to be adjusted for in future clinical trials and observational studies of acute pancreatitis.

Disclosure

I have no conflicts of interest to declare

Conference

UEG Week Barcelona 2026

Topics

Pancreas

Submission format

Abstract

Session

Acute pancreatitis: Causes, risks, and clinical outcomes (Posters)

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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