Non-superiority of lumen-apposing metal stents over plastic stents for drainage of walled-off necrosis in a randomised trial

ObjectiveAlthough lumen-apposing metal stents (LAMS) are increasingly used for drainage of walled-off necrosis (WON), their advantage over plastic stents is unclear. We compared efficacy of LAMS and plastic stents for WON drainage.DesignPatients with WON were randomised to endoscopic ultrasound-guided drainage using LAMS or plastic stents. Primary outcome was comparing total number of procedures to achieve treatment success defined as symptom relief in conjunction with WON resolution on CT at 6 months. Secondary outcomes were treatment success, procedure duration, clinical/stent-related adverse events, readmissions, length of hospital stay (LOS) and costs.Results60 patients underwent LAMS (n=31) or plastic stent (n=29) placement. There was no significant difference in total number of procedures performed (median 2 (range 2–7) LAMS vs 3 (range 2–7) plastic, p=0.192), treatment success, clinical adverse events, readmissions, LOS and overall treatment costs between cohorts. Although procedure duration was shorter (15 vs 40 min, p<0.001), stent-related adverse events (32.3% vs 6.9%, p=0.01) and procedure costs (US$12 155 vs US$6609, p<0.001) were higher with LAMS. Significant stent-related adverse events were observed ≥3 weeks postintervention in LAMS cohort. Interim audit resulted in protocol amendment where CT scan was obtained at 3 weeks postintervention followed by LAMS removal if WON had resolved. After protocol amendment, there was no significant difference in adverse events between cohorts.ConclusionExcept for procedure duration, there was no significant difference in treatment outcomes between LAMS and plastic stents. To minimise adverse events with LAMS, patients should undergo follow-up imaging and stent removal at 3 weeks if WON has resolved.Trial registration numberNCT02685865.

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Early removal of biflanged metal stents in the management of pancreatic walled-off necrosis: a prospective study

Endoscopy ◽

10.1055/s-0043-123575 ◽

2017 ◽

Vol 50 (06) ◽

pp. 597-605 ◽

Cited By ~ 12

Author(s):

Vinay Dhir ◽

Douglas Adler ◽

Ankit Dalal ◽

Nitin Aherrao ◽

Rahul Shah ◽

...

Keyword(s):

Adverse Events ◽

Pancreatic Duct ◽

Recurrence Rate ◽

Plastic Stents ◽

Metal Stents ◽

Plastic Stent ◽

Early Removal ◽

Pancreatic Duct Stenting ◽

Walled Off Necrosis

Abstract Background and study aims Dedicated stents placed under endoscopic ultrasound (EUS) guidance have shown promise for the management of pancreatic walled-off necrosis (WON). A long duration of stent placement may increase the risk of adverse events. We prospectively evaluated the effects of (i) early removal of biflanged metal stents (BFMSs) and (ii) additional stenting of the pancreatic duct with plastic stents in patients with ductal leaks, on the risk of WON recurrence. Patients and methods Symptomatic patients with pancreatic WON underwent EUS-guided BFMS placement, followed by necrosectomy, when required, from Day 3. A 5 Fr plastic stent was placed in patients with ductal leak. BFMS was removed when the WON cavity had collapsed completely. Patients were followed up at 3-month intervals. Results BFMS placement was successful in all 88 patients. A total of 64 patients (72.7 %) underwent necrosectomy (median 3 sessions). All BFMSs were removed at a median of 3.5 weeks (range 3 – 17 weeks). Ductal disconnection and leak occurred in 53/87 (60.9 %) and 61/87 (70.1 %) patients, respectively. A 5 Fr stent was placed in 56/61 patients (91.8 %) with ductal leak. Overall, 22 patients (25.0 %) had adverse events (17 mild, 1 moderate, 3 severe, 1 fatal). Recurrence was noted in 8/88 (9.1 %) at a median follow-up of 22 months. The recurrence rate was higher in patients with ductal disconnection than in those without (13.2 % vs. 2.9 %; P = 0.08), and was similar in patients with vs. without pancreatic duct stenting (7.1 % vs. 12.9 %; P = 0.44). Seven recurrences (87.5 %) partially regressed on follow-up and did not require therapy; in one case, drainage with a plastic stent was performed. Conclusions Short-term BFMS placement is an effective therapy for pancreatic WON. The majority of recurrences developed in patients with ductal disconnection and did not require therapy. Additional pancreatic duct stents probably do not influence the recurrence rate.

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Faculty Opinions recommendation of Non-superiority of lumen-apposing metal stents over plastic stents for drainage of walled-off necrosis in a randomised trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.733367661.793565112 ◽

2019 ◽

Author(s):

Kofi Oppong ◽

Stewart Bonnington

Keyword(s):

Randomised Trial ◽

Plastic Stents ◽

Metal Stents ◽

Walled Off Necrosis

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A new 12-French plastic stent for unresectable distal malignant biliary obstruction

Endoscopy ◽

10.1055/a-1120-8498 ◽

2020 ◽

Vol 52 (06) ◽

pp. 474-482

Author(s):

Pierre H. Deprez ◽

Tom G. Moreels ◽

Tarik Aouattah ◽

Hubert Piessevaux ◽

Enrique Pérez-Cuadrado-Robles

Keyword(s):

Adverse Events ◽

Biliary Obstruction ◽

Malignant Biliary Obstruction ◽

Plastic Stents ◽

Metal Stents ◽

Technical Success ◽

Stent Patency ◽

Historical Cohort ◽

Plastic Stent ◽

Distal Malignant Biliary Obstruction

Background Self-expanding metal stents (SEMSs) are recommended in unresectable distal malignant biliary obstruction. However, problems with dysfunction and migration of these stents are not negligible. We aimed to investigate the effectiveness and safety of a new 12-Fr plastic stent. Methods In an observational, prospective study, all consecutive patients who underwent biliary stenting with the 12-Fr stent were considered (index group). Referent groups were a historical cohort, matched by sex, etiology, and metastatic status, including patients with 10-Fr plastic stents and with fully covered and uncovered SEMSs (FCSEMSs and UCSEMSs). Outcomes were stent patency, recurrent biliary obstruction (RBO), technical success, 30-day mortality and adverse events. A post-procedure examination of removed stents was done. Results 72 patients (median age 66, range 32 – 94 years, 50 % men) were included (24 index, 48 referents). There were no differences in median stent patency time (P = 0.684). RBO was significantly lower with the 12-Fr compared with the 10-Fr profile stent (50 % vs. 81.3 %, P = 0.04), but no difference was found compared with the FCSEMSs (50 % vs. 43.8 %, P = 0.698). Technical success was 100 %, with no differences in 30-day mortality P = 0.105). The adverse events rate was 4.2 % for both groups (index n = 1, referents n = 2). Of 11 removed 12-Fr plastic stents suspected to be dysfunctional, 7 (64 %) were still patent. Conclusions This new 12-Fr plastic stent could be an effective and cheaper alternative to SEMSs in distal malignant biliary obstruction.

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Efficacy of the New Double-Layer Stent for Unresectable Distal Malignant Biliary Obstruction: A Single-Center Retrospective Study

Diagnostic and Therapeutic Endoscopy ◽

10.1155/2012/680963 ◽

2012 ◽

Vol 2012 ◽

pp. 1-8 ◽

Cited By ~ 3

Author(s):

Ken Ito ◽

Yoshinori Igarashi ◽

Takahiko Mimura ◽

Yui Kishimoto ◽

Yoshinori Kikuchi ◽

...

Keyword(s):

Life Expectancy ◽

Biliary Obstruction ◽

Malignant Biliary Obstruction ◽

Plastic Stents ◽

Metal Stents ◽

Short Life ◽

First Choice ◽

Significant Difference ◽

Distal Malignant Biliary Obstruction ◽

Short Life Expectancy

Background and Aims. For distal malignant biliary obstruction in cases with short life expectancy, occlusion of plastic stents (PSs) does not usually occur before death, and the application of such a procedure is considered adequate from the viewpoint of cost-effectiveness. Methods and Setting. A new commercially available DLS with side holes, a conventional DLS, and, uncovered self-expanding metal stents (SEMSs) were retrospectively evaluated in patients with jaundice due to unresectable distal malignant biliary obstruction. Results. A total of 64 patients received endoscopic biliary stenting (23 patients with the new DLS, 24 patients with conventional DLS, and 17 patients with uncovered SEMS) from December 2002 to August 2009. Median patency time was found to be 198 days for the new DLS group and 99 days for the conventional DLS group, revealing a significant difference between devices. There was, however, no significant difference in median patency time between the new DLS and the uncovered SEMS (198 days versus 344 days). Conclusion. The new DLS is efficient and safe and may be considered the first choice for unresectable distal malignant obstruction in cases with short life expectancy.

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628 Lumen Apposing Metal Stents Compared With Double Pigtail Plastic Stents in the Management of Pancreatic Pseudocysts and Walled-Off Necrosis: A 5 Year Single Center Study

Gastrointestinal Endoscopy ◽

10.1016/j.gie.2017.03.129 ◽

2017 ◽

Vol 85 (5) ◽

pp. AB90 ◽

Cited By ~ 1

Author(s):

Bryan B. Brimhall ◽

Samuel Han ◽

Philip D. Tatman ◽

Brian C. Brauer ◽

Sachin B. Wani ◽

...

Keyword(s):

Plastic Stents ◽

Pancreatic Pseudocysts ◽

Metal Stents ◽

Single Center ◽

Single Center Study ◽

Walled Off Necrosis ◽

Center Study

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Sciatic obturator femoral technique versus spinal anaesthesia in patients undergoing surgery for fixation of open tibial fractures using Ilizarov external fixator. A randomised trial

BMC Anesthesiology ◽

10.1186/s12871-019-0920-6 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Hoda Shokri ◽

Amr A. Kasem

Keyword(s):

Adverse Events ◽

Spinal Anaesthesia ◽

External Fixator ◽

Randomised Trial ◽

Study Groups ◽

Tibial Fractures ◽

Hyperbaric Bupivacaine ◽

Ilizarov External Fixator ◽

Open Tibial Fractures ◽

Significant Difference

Abstract Background Peripheral nerve block is preferable for lower extremity surgery because it sufficiently blocks pain pathways at different levels providing excellent anaesthesia at the site of surgery. We designed this study to compare the efficacy and safety of SOFT block (sciatic-obturator-femoral technique) compared with spinal anaesthesia in patients undergoing surgery for fixation of open tibial fractures using Ilizarov external fixator. Methods One hundred and seven patients ASA I, II scheduled for fixation of open tibial fractures using Ilizarov external fixator. The patients were randomly allocated to receive either spinal anaesthesia or SOFT block. In spinal anaesthesia group, patients received spinal anaesthesia with hyperbaric bupivacaine 0.5% (7. 5-10mg). In SOFT group, patients received SOFT block with bupivacaine 0.25%. Primary endpoint included the duration of analgesia. The secondary endpoints included patient satisfaction scores, visual analogue scores, incidence of adverse events as vomiting, systemic toxicity from local anaesthetic drug and time to first effect of the techniques. Results The duration of SOFT block and time to first analgesic dose in SOFT group was significantly longer (p < 0.001). There was no significant difference between the study groups regarding satisfaction scores, the incidence of cardiovascular collapse, seizures and paraesthesia. Pain scores were significantly lower in SOFT group at 3,6,12 h postoperative (p < 0.001). The time to the first effect was significantly longer in SOFT group (p < 0.001). Conclusion SOFT is a feasible technique of local anaesthesia for control of postoperative pain with unremarkable adverse events compared with spinal anaesthesia, in patients undergoing fixation of tibial fractures using Ilizarov external fixator. Trial registration This trial was retrospectively registered at ClinicalTrials.gov. registry number: NCT03450798 on February 20, 2018.

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53 A Multicenter Comparative Analysis of Double Pigtail Plastic Stents and Lumen-Apposing Metal Stents for Endoscopic Drainage of Pancreatic Walled-Off Necrosis in the Pediatric Population: Evaluation of Clinical Outcomes and Success

Gastrointestinal Endoscopy ◽

10.1016/j.gie.2017.03.034 ◽

2017 ◽

Vol 85 (5) ◽

pp. AB45-AB46

Author(s):

Jose Nieto ◽

Maisam Abu-El-Haija ◽

Bradley Barth ◽

Travis L. Piester ◽

Andrew R. Dargan ◽

...

Keyword(s):

Comparative Analysis ◽

Clinical Outcomes ◽

Pediatric Population ◽

Plastic Stents ◽

Metal Stents ◽

Endoscopic Drainage ◽

Walled Off Necrosis

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Endoscopic ultrasound-guided placement of plastic pigtail stents for the drainage of refractory malignant ascites

Endoscopy International Open ◽

10.1055/s-0043-118746 ◽

2017 ◽

Vol 05 (11) ◽

pp. E1096-E1099 ◽

Cited By ~ 1

Author(s):

Rafael Romero-Castro ◽

Victoria Jimenez-Garcia ◽

Jaime Boceta-Osuna ◽

Luis Castilla-Guerra ◽

Francisco Pellicer-Bautista ◽

...

Keyword(s):

Endoscopic Ultrasound ◽

Poor Prognosis ◽

Malignant Ascites ◽

Refractory Ascites ◽

Plastic Stents ◽

Pancreatic Pseudocysts ◽

Metal Stents ◽

Ultrasound Guided ◽

Walled Off Necrosis

AbstractEndoscopic ultrasound (EUS)-guided drainage is now the treatment of choice in cases of pancreatic pseudocysts and walled-off necrosis, especially in the absence of luminal bulging and in patients with portal hypertension. Malignant refractory ascites usually heralds a poor prognosis and substantially impairs the quality of life of patients because of the symptoms experienced and the need for repeated paracentesis. EUS-guided placement of lumen-apposing, fully covered, self-expandable metal stents (FCSEMS) has been reported for the drainage of malignant ascites. Herein, we present the results of EUS-guided placement of plastic pigtails stents for the drainage of refractory malignant ascites in three patients. The aim was to improve symptoms and minimize the possible drawbacks of large-caliber FCSEMS. In this preliminary experience, EUS-guided placement of plastic stents was feasible and avoided further paracentesis.

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