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Prospective, Multicenter RCT for Management of High-Grade Pediatric Pancreatic Trauma

Background: There is controversy regarding the benefits of non-operative vs. operative management for high-grade pancreatic injuries in children. Practice patterns vary among institutions and providers (equipoise). Literature thus far based on low levels of evidence.

Hypothesis: Operative management of children with high-grade, blunt pancreatic injury (compared to non-operative management) leads to shorter hospital length of stay (primary outcome) and less short and long-term complications (secondary outcome).

Study Design: Prospective, multicenter, randomized study.

Primary Outcome: Hospital length of stay (best variable to power study based on current data)

Secondary Outcomes: Total number of missed school days, formation of persistent pseudocyst (> 4 weeks), total number of procedures within 30 days, short-term complications within 30 days (fistula, infection, bowel obstruction), long-term complications within 3 and 6 months (pancreatic insufficiency and others above).

Sample Size: 124 (62 in each arm) based on average hospital LOS. Assuming 10% drop-out rate, 136 (68 in each arm).

Methods:

  1. Population:
    • Inclusion criteria: Children < age 18 who with isolated, blunt pancreatic trauma who have evidence of duct injury (AAST grade III proven by MRCP) and no evidence of bleeding or bowel injury necessitating operation
    • Exclusion criteria: Serious co-morbidities, immunosuppressed state, injury occurred > 24 hours before arrival, AIS > 2 in any other system
  2. Procedure for randomization to Operative vs. Non-operative group: pre-planned, centralized
  3. Interventions per group:
    • Operative - distal pancreatectomy within 48 hours of presentation
    • Non-Operative - consensus on management to be determined by study group
  4. Follow-up for both groups:
    • 2 and 4 week routine clinic follow up
    • Ultrasound at 4 weeks to document persistent pseudocyst
    • Telephone/in person interview at 3 and 6 months

Analysis Plan: Statistical comparison of outcomes among groups based on centralized data collection results.

For more information, please contact Dr. Bindi Naik-Mathuria.