International, multicenter retrospective trial comparing the efficacy and safety of bi-flanged versus lumen-apposing metal stents for endoscopic drainage of walled-off pancreatic necrosis.
To compare fully covered bi-flanged metal stents (BFMS) and lumen-apposing metal stents (LAMS) for endoscopic ultrasound (EUS)-guided drainage/debridement of pancreatic walled-off necrosis (WON).
Patients with WON managed by EUS-guided therapy were divided into those who underwent: 1) drainage using BFMS; and 2) drainage using LAMS and scheduled direct endoscopic necrosectomy (DEN). Clinical success (resolution of the WON), technical success (successful stent placement), and adverse events (AEs) were evaluated.
387 patients underwent WON endoscopic drainage, 205 using BFMS and 182 using LAMS. The clinical success in the BFMS or LAMS groups were similar (197 [96.1%] vs. 174 [95.6%]; P=0.81). Median number of procedures required for WON resolution was significantly lower in BFMS compared to LAMS (2 vs. 3, P<0.001). Technical success for stent placement was similar in BFMS and LAMS groups (203 [99%] vs. 180 [99%], P=0.90). Procedure-related AEs were similar in the BFMS and LAMS groups (19 [9.3%] vs. 20 [10.9%], P=0.61). Stent dysfunction with occluding debris was higher in the BFMS group compared to LAMS group (21 [10.2 %] vs. 11 [5.9%], P=0.04). The migration rate was higher in the BFMS group than in the LAMS group (15 [7.3%] vs. 3 [1.6%]; P<0.001). DEN was required in 23 [11.2%] patients in the BFMS group after lack of WON resolution by conservative means.
BFMS with a "step-up approach" and LAMS with scheduled DEN are both safe and effective for EUS-guided drainage/debridement of WON.
Siddiqui A
，Naveed M
，Basha J
，Lakhtakia S
，Nieto J
，Shah J
，Binmoeller K
，Murphy M
，Talukdar R
，Ramchandani MK
，Nabi Z
，Gupta R
，Kowalski TE
，Loren DE
，Sharaiha RZ
，Kahaleh M
，Eyck PT
，Noor A
，Mumtaz T
，Kalalala R
，Reddy ND
，Adler DG
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Endoscopic ultrasonography-guided transmural drainage of walled-off pancreatic necrosis: Comparison between a specially designed fully covered bi-flanged metal stent and multiple plastic stents.
Endoscopic ultrasonography (EUS)-guided drainage of walled-off necrosis (WON) may be carried out by placement of multiple plastic stents (MPS) or specially designed fully covered bi-flanged metal stents (BFMS). Comparative data on efficacy of these two stent types for WON drainage are limited. This retrospective study compares outcomes of WON drainage using BFMS and MPS.
During a 10-year period, 133 patients underwent EUS-guided WON drainage. MPS or BFMS were placed in a WON cavity through a single puncture, and direct endoscopic necrosectomy (DEN) was carried out whenever clinically necessary. Data in the two cohorts were retrospectively compared for primary outcomes - clinical success, adverse events and mortality; and secondary outcomes - DEN requirement, mean DEN sessions, need for salvage surgery and hospital stay.
MPS were placed in 61 and BFMS in 72 patients. Patients undergoing BFMS drainage required fewer DEN sessions (mean 1.46 vs 2.74, P < 0.05), had fewer adverse events (5.6% vs 36.1%, P < 0.05), needed salvage surgery less often (2.7% vs 26.2%, P < 0.05), and had significantly shorter hospital stay (4.1 vs 8 days, P < 0.05) compared to those undergoing MPS drainage. There was no difference in DEN requirement (P = 0.217) and mortality (P = 0.5) in both groups. Overall clinical success with BFMS was superior to MPS (94% vs 73.7%, P < 0.05).
BFMS appear to be superior to MPS for EUS-guided WON drainage in terms of clinical success, number of DEN sessions, adverse events, need for salvage surgery and hospital stay.
Bapaye A
，Dubale NA
，Sheth KA
，Bapaye J
，Ramesh J
，Gadhikar H
，Mahajani S
，Date S
，Pujari R
，Gaadhe R
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Fully covered self-expanding metal stents versus lumen-apposing fully covered self-expanding metal stent versus plastic stents for endoscopic drainage of pancreatic walled-off necrosis: clinical outcomes and success.
Endoscopic transmural drainage/debridement of pancreatic walled-off necrosis (WON) has been performed using double-pigtail plastic (DP), fully covered self-expanding metal stents (FCSEMSs), or the novel lumen-apposing fully covered self-expanding metal stent (LAMS). Our aim was to perform a retrospective cohort study to compare the clinical outcomes and adverse events of EUS-guided drainage/debridement of WON with DP stents, FCSEMSs, and LAMSs.
Consecutive patients in 2 centers with WON managed by EUS-guided debridement were divided into 3 groups: (1) those who underwent debridement using DP stents, (2) debridement using FCSEMSs, (3) debridement using LAMSs. Technical success (ability to access and drain a WON by placement of transmural stents), early adverse events, number of procedures performed per patient to achieve WON resolution, and long-term success (complete resolution of the WON without need for further reintervention at 6 months after treatment) were evaluated.
From 2010 to 2015, 313 patients (23.3% female; mean age, 53 years) underwent WON debridement, including 106 who were drained using DP stents, 121 using FCSEMSs, and 86 using LAMSs. The 3 groups were matched for age, cause of the pancreatitis, WON size, and location. The cause of the patients' pancreatitis was gallstones (40.6%), alcohol (30.7%), idiopathic (13.1%), and other causes (15.6%). The mean cyst size was 102 mm (range, 20-510 mm). The mean number of endoscopy sessions was 2.5 (range, 1-13). The technical success rate of stent placement was 99%. Early adverse events were noted in 27 of 313 (8.6%) patients (perforation in 6, bleeding in 8, suprainfection in 9, other in 7). Successful endoscopic therapy was noted in 277 of 313 (89.6%) patients. When comparing the 3 groups, there was no difference in the technical success (P = .37). Early adverse events were significantly lower in the FCSEMS group compared with the DP and LAMS groups (1.6%, 7.5%, and 9.3%; P < .01). At 6-month follow-up, the rate of complete resolution of WON was lower with DP stents compared with FCSEMSs and LAMSs (81% vs 95% vs 90%; P = .001). The mean number of procedures required for WON resolution was significantly lower in the LAMS group compared with the FCSEMS and DP groups (2.2 vs 3 vs 3.6, respectively; P = .04). On multivariable analysis, DP stents remain the sole negative predictor for successful resolution of WON (odds ratio [OR], 0.18; 95% confidence interval, 0.06-0.53; P = .002) after adjusting for age, sex, and WON size. Although there was no significant difference between FCSEMSs and LAMSs for WON resolution, the LAMS was more likely to have early adverse events (OR, 6.6; P = .02).
EUS-guided drainage/debridement of WON using FCSEMSs and LAMSs is superior to DP stents in terms of overall treatment efficacy. The number of procedures required for WON resolution was significantly lower with LAMSs compared with FCSEMSs and DP stents.
Siddiqui AA
，Kowalski TE
，Loren DE
，Khalid A
，Soomro A
，Mazhar SM
，Isby L
，Kahaleh M
，Karia K
，Yoo J
，Ofosu A
，Ng B
，Sharaiha RZ
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