World Congress at ACG2017

Simultaneous Plenary Session 1D: Late-Breaking Abstracts

21 - Minimally Invasive Surgery versus Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis

Monday, October 16
4:40 PM - 4:50 PM
Location: W414 (Level 4)

Category: General Endoscopy       

Ji Young Bang, MD, MPH, Pablo Arnoletti, MD, Muhammad Hasan, MD, Udayakumar Navaneethan, MD, Bryce Sutton, PhD, Robert H. Hawes, MD, FACG, Shyam Varadarajulu, MD
Center for Interventional Endoscopy, Florida Hospital, Orlando, FL
Introduction: Necrotizing pancreatitis is a highly morbid disease with poor clinical outcomes. Treatment strategy has evolved over time from open necrosectomy to other minimally invasive techniques. Aim is to compare the clinical outcomes between minimally invasive surgery (MIS) and endoscopic approaches for treatment of necrotizing pancreatitis.

Methods: Consecutive patients with necrotizing pancreatitis were randomized to MIS or endoscopic interventions. MIS involved laparoscopic cystogastrostomy with internal debridement or video-assisted retroperitoneal debridement. Endoscopic interventions involved initial EUS-guided drainage by single-gate, multi-gate or dual (endoscopic and percutaneous drainage) modality techniques followed by necrosectomy if required. Patients who underwent only percutaneous drainage and did not require surgical or endoscopic interventions were excluded. Primary end point was to compare composite of major complications (new onset multi-organ failure, new onset multiple systemic complications, perforation of visceral organ, entero/pancreaticocutaneous fistula, bleeding) or death until 3 months. Secondary outcome measures were to compare treatment success (intention-to-treat), treatment failure, adverse events, reinterventions, length of stay (LOS), quality of life (QOL) and costs.

Results: 66 patients were randomized to endoscopic (n=34) or MIS (n=32). Primary outcome occurred in 5.9% of endoscopic and 34.4% of MIS cohorts (risk ratio 0.17; 95% CI, 0.04-0.71, p=0.004). While there was no significant difference in late-term treatment success (96.2 vs. 84.0%, p=0.19), endoscopy was associated with higher early (97.1 vs. 53.1%, p<0.001) and mid-term (100 vs. 81.3%, p=0.01) treatment success. Treatment failure was significantly higher for MIS (18.8% vs. 0, p=0.01). There was no significant difference in mortality (2.9 vs. 6.3%, p=0.61), adverse events (41.2 vs. 53.1%, p=0.33), reinterventions (44.1 vs. 28.1%, p=0.18) and LOS (median 14 days [IQR 6-22] vs. 18.5 days [IQR 11.5-29.5], p=0.057) between endoscopy and MIS cohorts, respectively. While there was no overall difference in QOL, physical component scores were better for endoscopy at 6-weeks (p=0.039). Mean total cost was lower for endoscopy ($75,830 vs $117,492, p=0.039).

Discussion: Endoscopy-based interventions, as compared to minimally invasive surgery, was associated with a lower rate of composite end point of major complications or death among patients with necrotizing pancreatitis.

Disclosures: Does Disclose

Robert H. Hawes: Consultant - Boston Scientific Corp., Olympus America Inc.
Shyam S. Varadarajulu: Consultant - Boston Scientific Corp., Olympus America, Inc.
All other authors have indicated no relevant financial relationships.

Citation: . MINIMALLY INVASIVE SURGERY VERSUS ENDOSCOPY RANDOMIZED (MISER) TRIAL FOR NECROTIZING PANCREATITIS. Program No. 21. World Congress of Gastroenterology at ACG2017 Meeting Abstracts. Orlando, FL: American College of Gastroenterology.

Ji Young Bang

Birmingham, AL


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21 - Minimally Invasive Surgery versus Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis

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