The endoscopic step-up approach was not superior to the surgical step-up approach for reducing long-term mortality or major complications in patients with infected necrotizing pancreatitis, according to study findings published in Gastroenterology.
For the current analysis, researchers performed a long-term follow-up study (ExTENSION) of the TENSION trial. TENSION was a randomized, multicenter, superiority study conducted at 19 hospitals in the Netherlands between 2011 and 2015. Patients (N=98) with infected necrotizing pancreatitis were randomly assigned to receive endoscopic (n=51) or surgical (n=47) step-up. For the ExTENSION study, researchers evaluated long-term mortality and major complication rates and QOL among these patients. Endoscopic step-up comprised percutaneous drainage using a transluminal or image guided approach followed by minimally invasive necrosectomy.
The average follow-up time was 82±18 and 84±19 months among the endoscopic and surgical step-up cohorts, respectively.
The composite outcome of mortality and major complications occurred among 53% of the endoscopic and 57% of the surgical step-up groups (relative risk [RR], 0.92; 95% CI, 0.65-1.32; P =.688).
No group differences were observed for mortality, new-onset organ failure, multiple new-onset organ failure, bleeding requiring intervention, perforation of a visceral organ or enterocutaneous fistula requiring intervention, incisional hernia, biliary stricture, wound infection, or pancreatic insufficiency.
The endoscopic step-up approach was associated with fewer pancreatic fistulas (8% vs 34%; RR, 0.23; 95% CI, 0.08-0.64; P =.002). However, when the follow-up data from the first 6 months was removed, no group difference in pancreatic fistula was observed (RR, 0.98; 95% CI, 0.14-6.61; P =1.00).
After the initial 6-month follow up, the endoscopic step-up approach was associated with fewer interventions (RR, 0.29; 95% CI, 0.09-0.99; P =.038) and additional endoscopic transluminal drainage procedures (RR, 0.14; 95% CI, 0.02-1.08; P =.029).
No group differences in QOL measurements were observed at 3 and 6 months or at long-term follow up.
Study limitations included a lack of QOL comparisons between randomization and the end of long-term follow up, and the extended follow-up time, which could have included complications not related to necrotizing pancreatitis. Further, follow-up timing was not standardized between patients, which could have affected clinical outcomes.
“In conclusion, we found no differences in mortality and major complications between the endoscopic and surgical step-up approach in patients with infected necrotizing pancreatitis in this long-term follow-up study,” the researchers noted. “However, the endoscopic approach led to overall fewer pancreaticocutaneous fistulas and resulted in fewer reinterventions after the initial 6-months’ follow-up. These results confirm that if feasible, the endoscopic approach should be preferred.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Onnekink AM, Boxhoorn L, Timmerhuis HC, et al. Endoscopic versus surgical step-up approach for infected necrotizing pancreatitis (ExTENSION): long-term follow-up of a randomized trial. Gastroenterology. Published online May 13, 2022. doi:10.1053/j.gastro.2022.05.015