Early selective enteral feeding in combination with active decompression of duodenum in treatment of moderate and severe acute pancreatitis - A proof-of-concept clinical study.

Background: Acute pancreatitis (AP) is a significant clinical challenge with rising global incidence and substantial mortality rates, necessitating effective treatment strategies. Current guidelines recommend pain and fluid management and early enteral feeding to mitigate complications, yet optimal feeding route remains debated.

Methods: We conducted a prospective, randomized, controlled trial at nine centers from October 2020 to May 2023, enrolling 154 patients with moderate to severe AP. Patients were stratified into biliary and non-biliary categories and randomized 1:1 to receive either standard of care (SoC) or SoC plus PandiCath®, a novel catheter enabling selective enteral feeding and duodenal decompression. The primary clinical endpoint (PCE) was a composite of de novo multiple organ dysfunction syndrome (MODS), infectious complications, pancreatic and intestinal fistula formation, bleeding, abdominal compartment syndrome, obstructive jaundice, and AP-related mortality.

Results: In the primary modified intention-to-treat analysis, PandiCath® significantly reduced the PCE compared to SoC alone (P = 0.032). The Relative Risk (RR = 0.469, 95 % CI 0.228-0.964) and Number Needed to Treat (NNT = 6.384, 95 % CI 3.349-68.167) indicated its substantial clinical benefit, primarily driven by reduced rates of de novo MODS and infectious complications. These findings were further supported by the evaluation of other populations, including the standard intention-to-treat analysis.

Conclusion: PandiCath®, facilitating targeted enteral feeding while isolating and decompressing the duodenum, demonstrates promise in improving outcomes for AP patients at risk of severe complications. Further studies are warranted to validate these findings and explore optimal timing and patient selection for this intervention.