Introduction
Endoscopic step-up approach comprising EUS-guided (endoscopic ultrasound) transmural drainage with or without direct endoscopic necrosectomy (DEN) is the standard of care for centrally placed necrotic collections in patients with ANP (acute necrotising pancreatitis). However, after initial EUS-guided drainage, the timing and frequency of endoscopic necrosectomy are still evolving.
Aims & Methods
To compare the outcomes of a top-down vs. step-up approach after EUS-guided drainage of the infected pancreatic necrotic collection.
We performed a single-centre, open-label, randomised trial. We included patients with ANP who had a proven or clinically suspected infected WON (walled--off necrosis) greater than 10 cm in size and more than 30% solid debris, which should be suitable for EUS-guided drainage. In the top-down arm, the patient received an up-front DEN in the same session of initial EUS-guided drainage. The necrosectomy was performed using conventional accessories in both arms. The DEN was continued till complete removal of all debris or 60 minutes of the procedure, whichever is earlier. In case of incomplete clearance, the patient was again taken up for the endoscopic necrosectomy after 24 hours of the initial procedure. This process continued until complete clearance of the necrotic debris, along with visualization of the healthy granulation tissue in most of the cavity. In the step-up approach, after initial EUS-guided drainage, necrosectomy was performed only in the presence of pre-defined clinical criteria (non-response or worsening of SIRS and/or organ failure at 72 hours). The primary endpoint was the number of re-interventions per patient required after the index drainage procedure to achieve clinical success till 3 months of follow-up. Secondary endpoints were the time for resolution of SIRS, new onset organ failure, procedure-related complications, the requirement of re-hospitalisation, total hospitalisation days and all-cause mortality. An intention-to-treat analysis on all randomly assigned patients was performed for the primary and secondary endpoints.
Results
Out of 208 patients screened during the study period, 54 were enrolled (27 in each group). The mean age was 38.70 ± 12.58, and gallstone pancreatitis was the most common aetiology (48.1%). Half the patients had severe disease with a median APACHE II Score of 8 (IQR 7-10). 42 patients (77.8%) had culture-positive infected necrotic collections, and 12 patients (22.2%) had clinically suspected infection. All enrolled patients achieved technical success. The median number of re-interventions required in the top-down arm was lower (1 (0-2) vs 2 (1-3); p=0.02). All patients in the top-down arm underwent DEN, and 77.8% of patients (n=21) in the step-up arm required DEN for clinical success. Patients in the step-up arm had higher re-admissions (44.4% vs 18.5%; p=0.04) and prolonged hospitalization (12 (8.5-20.5) vs 4 (2-10.5) ; p<0.01) compared to the other arm. Time for resolution SIRS (2 (1-8.25) vs 3.5 (2-18); vs; p=0.051), procedure-related complications (7.4% vs 7.4%; p=1.0), new onset organ failure (11.1 % vs 14.8%; p=0.68), and mortality (11.1% vs 18.5%; p=0.44) were equivalent across both arms.
Conclusion
In patients with large infected WON with significant solid debris (>30%), the top-down approach comprising an upfront and complete necrosectomy reduces the requirement of re-interventions, re-admissions and total hospitalisation days.
Trial Registration: ctri.nic.in (CTRI/2024/01/061515)
References
1.Bang JY, Arnoletti JP, Holt BA, Sutton B, Hasan MK, Navaneethan U, Feranec N, Wilcox CM, Tharian B, Hawes RH, Varadarajulu S. An Endoscopic Transluminal Approach, Compared With Minimally Invasive Surgery, Reduces Complications and Costs for Patients With Necrotizing Pancreatitis. Gastroenterology. 2019 Mar;156(4):1027-1040.e3. doi: 10.1053/j.gastro.2018.11.031.
2. Bang JY, Lakhtakia S, Thakkar S, Buxbaum JL, Waxman I, Sutton B, Memon SF, Singh S, Basha J, Singh A, Navaneethan U, Hawes RH, Wilcox CM, Varadarajulu S; United States Pancreatic Disease Study Group. Upfront endoscopic necrosectomy or step-up endoscopic approach for infected necrotising pancreatitis (DESTIN): a single-blinded, multicentre, randomised trial. Lancet Gastroenterol Hepatol. 2024 Jan;9(1):22-33. doi: 10.1016/S2468-1253(23)00331-X.
3. Yan L, Dargan A, Nieto J, Shariaha RZ, Binmoeller KF, Adler DG, DeSimone M, Berzin T, Swahney M, Draganov PV, Yang DJ, Diehl DL, Wang L, Ghulab A, Butt N, Siddiqui AA. Direct endoscopic necrosectomy at the time of transmural stent placement results in earlier resolution of complex walled-off pancreatic necrosis: Results from a large multicenter United States trial. Endosc Ultrasound. 2019 May-Jun;8(3):172-179.
