Risk Factors for Acute Pancreatitis Following Intragastric Balloon Insertion: A 7-Year Retrospective Cohort Study

Over 7 years, this study identified 25 cases of IGB-related AP, primarily in young females (mean age 24.5 years, BMI 34). This demographic profile aligns with previous IGB-AP reports [13, 16,17,18,19], as young women are more likely to pursue weight management interventions due to societal expectations, self-image concerns, and health considerations [20, 21]. The incidence of AP in our study was 5.56%, which is significantly higher than that reported in a recent meta-analysis (0.006%) [22]. It is important to note that our study was not designed to calculate AP incidence as a primary outcome. This discrepancy with previous studies may be due to underreporting, as AP symptoms often mimic routine post-IGB discomfort, leading to delays in seeking care. As the primary center for post-IGB complications in the country, we may have captured more cases, potentially overestimating the incidence. In contrast, lower AP rates in earlier studies may reflect smaller sample sizes, shorter follow-up periods, or a reliance on voluntary reporting systems. Additionally, ethnic or genetic factors may have contributed to the observed differences.

Cox and logistic regression analyses identified balloon type as a factor associated with AP, with the Orbera balloon showing a lower hazard rate compared to other types. While prior case reports and series indicated more Orbera cases [13, 16], our analysis revealed the opposite, emphasizing the importance of rigorous statistical methods in identifying true risk factors. Furthermore, IGB insertion outside the primary setting was linked to a lower AP risk, potentially due to differences in procedural techniques, follow-up, or patient characteristics. However, unmeasured confounders related to insertion location may also play a role. Although age and higher BMI appeared to have a protective effect against AP, the findings did not reach statistical significance. Age-related pancreatic changes, such as steatosis, fibrosis, and enzyme reduction, may lower inflammation [23]. Additionally, visceral adipose tissue in individuals with higher BMI might provide mechanical protection to the pancreas [24]. While plausible, these hypotheses remain speculative and require further investigation.

The duration from IGB insertion to AP exhibited substantial variability among cases, with a median of 40 days post-insertion. Similar variability has been observed in previous case reports and series [13, 16]. While no definitive explanation exists for this variability, our findings emphasize the necessity of vigilant monitoring of patients following IGB insertion, not only in the initial weeks, as AP can occur at any point throughout the post-insertion period. IGB removal was performed in most cases, aligning with reported IGB-AP management [13, 16]. While no consensus exists for mandatory removal in mild AP, Brazilian and Spanish consensus (based on 20,000–40,000 cases) suggest it may not be necessary, leaving the decision to clinical judgment on a case-by-case basis [25, 26].

To address potential confounders, we investigated other AP causes. Abdominal ultrasonography identified one case of gallbladder stones and two with sludge. However, no recurrent AP episodes occurred over 1 year despite gallbladders remaining in situ. This observation is significant, as patients with gallbladders in situ have been shown to have up to a 45% recurrence rate within 6 months after initial biliary pancreatitis [27, 28], suggesting that biliary etiology is unlikely in our cases. Additionally, only one patient reported occasional alcohol use, with no AP recurrence over 1 year, reducing alcohol as a likely factor. No cases of hypertriglyceridemia were identified.

This study has several strengths. To the best of our knowledge, this is the largest study on IGB-related AP to date. Time-to-event analysis and Cox regression provided key insights into the timing and risk factors for AP, while extended follow-up (up to 1 year) allowed the detection of recurrent episodes and comprehensive patient outcomes. This study offers a robust evaluation of AP risk by examining various confounding factors, including IGB type. Despite its strengths, this study has several limitations. The sample size, although the largest for IGB-related AP, remained relatively small. The predominant use of the Orbera balloon introduces selection bias, limiting its generalizability to other balloon types. As a retrospective study, it is subject to biases (information, selection, and observer bias) that may affect data accuracy. Additionally, missing variables, such as balloon volume, restricted our analysis and may have influenced our findings.

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