Efficacy and safety of EUS-guided gastroenterostomy for benign and malignant gastric outlet obstruction: a systematic review and meta-analysis.
ABSTRACT: Background and study aims? Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is a novel endoscopic procedure designed to facilitate sustained luminal patency in patients with gastric outlet obstruction. The primary aim of this study was to evaluate the efficacy and safety of EUS-GE for treatment of gastric outlet obstruction. Methods? Searches of PubMed, EMBASE, Web of Science, and Cochrane Library databases were performed through April 2019. Patients with benign and malignant gastric outlet obstruction were included. Measured outcomes included: immediate technical and clinical success as well as rate of serious adverse events (AEs). Heterogeneity was assessed with Cochran Q test and I 2 statistics. Publication bias was ascertained by funnel plot and Egger regression testing. Results? A total of five studies (n?=?199 patients; 45.73?% male) were included in this study. Four retrospective studies and one prospective study were analyzed. Mean age of patients that underwent the EUS-GE procedure was 64.52?±?1.37 years with a pooled mean follow-up period of 4.32?±?1.65 months. In 21?% of patients (n?=?43), gastric outlet obstruction was due to benign causes. Immediate technical success was 92.90?% (95?% CI; 88.26?-?95.79; I 2 ?=?0.00?%) and reported in all studies. The clinical success rate of EUS-GE was 90.11?% (95?% CI; 84.64?-?93.44; I 2 ?=?0.00?%). Serious AEs occurred in 5.61?% (95?% CI; 2.87?-?10.67; I 2 ?=?1.67?%) of cases and were related to peritonitis, perforation, bleeding, and abdominal pain. Re-intervention rate was 11.43?% (95?% CI; 7.29?-?17.46; I 2 ?=?17.38?%). Conclusions? EUS-GE appears to provide an effective and safe minimally invasive alternative for treatment of benign and malignant gastric outlet obstruction.
Project description:<b>Background and study aims</b> ?Endoscopic and surgical techniques have been utilized for palliation of gastric outlet obstruction (GOO). Enteral stenting (ES) is an established technique with high clinical success and low morbidity rate. Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is a novel approach that aims to provide sustained palliation of GOO. We conducted a comprehensive review and meta-analysis to evaluate the effectiveness in terms of clinical and technical success, as well as the safety profile of EUS-GE and ES. <b>Methods</b> ?We searched multiple databases from inception through July 2020 to identify studies that reported on safety and effectiveness of EUS-GE in comparison to ES.?Pooled rates of technical success, clinical success, and adverse events (AEs) were calculated. Study heterogeneity was assessed using I <sup>2</sup> % and 95?% confidence interval. <b>Results</b> ?Five studies including 659 patients were included in our final analysis. Pooled rate of technical and clinical success for EUS-GE was 95.2?% (CI 87.2-.98.3, I <sup>2</sup> ?=?42) and 93.3?% (CI 84.4-97.3, I <sup>2</sup> ?=?59) while for ES it was 96.9?% (CI 90.9-99, I <sup>2</sup> ?=?64) and 85.6?% (CI 73-92.9, I <sup>2</sup> ?=?85), respectively. Pooled rate of re-intervention was significantly lower with EUS-GE i.?e. 4?% (CI 1.8-8.7, I <sup>2</sup> ?=?35) compared to ES, where it was 23.6?% (CI 17.5-31, I <sup>2</sup> ?=?35), p?=?0.001 <b>.</b> Pooled rates of overall and major AEs were comparable between the two techniques. <b>Conclusion</b> ?EUS-GE is comparable in terms of technical and clinical effectiveness and has a similar safety profile when compared to ES for palliation of GOO.
Project description:<h4>Background</h4>Gastric outlet obstruction can result from several benign and malignant diseases, in particular gastric, duodenal or pancreatic tumors. Surgical gastroenterostomy and enteral endoscopic stenting have represented effective therapeutic options, although recently endoscopic ultrasound-guided gastroenterostomy using lumen-apposing metal stent (LAMS) is spreading improving the outcome of this condition. However, this procedure, although mini-invasive, is burdened with not negligible complications, including misdeployment.<h4>Main body</h4>We report the case of a 60-year-old male with gastric outlet obstruction who underwent ultrasound-guided gastroenterostomy using LAMS. The procedure was complicated by LAMS misdeployment being managed by laparoscopy-assisted placement of a second LAMS. We performed a systematic review in order to identify all reported cases of misdeployment in EUS-GE and their management. The literature shows that misdeployment occurs in up to 10% of all EUS-GE procedures with a wide spectrum of possible strategies of treatment.<h4>Conclusion</h4>The here reported hybrid technique may offer an innovative strategy to manage LAMS misdeployment when this occurs. Moreover, a hybrid approach may be valuable to overcome this complication, especially in early phases of training of EUS-guided gastroenterostomy.
Project description:Background and Aims:Certain situations preclude an endoscopic gastroenterostomy (EUS-GE) or enteral stent placement in gastric outlet obstruction (GOO), leaving patients with the option of a surgical bypass or enteral nutrition beyond the point of obstruction. We present a third option in these situations: an endoscopic duodenojejunostomy (EUS-DJ) or jejunojejunostomy (EUS-JJ). Methods:This was a retrospective review of 5 patients whose anatomy precluded an endoscopic gastrojejunostomy and an enteral stent, who underwent a successful EUS-DJ or EUS-JJ from 2016 to 2018. Results:Four EUS-DJs and 1 EUS-JJ were performed, with use of a 15-mm cautery-enhanced lumen-apposing metal stent by direct technique. All cases were technically successful. Three patients tolerated an unrestricted diet, but 2 patients needed enteral supplementation or total parenteral nutrition because of severe gastroparesis. There was 1 moderate adverse event: bleeding from severe reflux esophagitis and gastroparesis. No reinterventions were needed on any of these stents, for a median follow-up time of 23 weeks. Conclusions:When anatomy precludes an EUS-GE or enteral stent, an EUS-DJ or EUS-JJ may have similarly successful outcomes and could help avoid the need for enteral feeding tubes or surgery.
Project description:BACKGROUND:Surgical gastrojejunostomy and enteral self-expanding metal stents are efficacious for the management of gastric outlet obstruction but limited by high complication rates and short-term efficacy. Endoscopic ultrasound-guided gastrojejunostomy (EUS-GJ) is a novel alternative option. PATIENTS AND METHODS:Patients who underwent EUS-GJ between March 2014 and September 2015 as part of a prospective multicenter registry at four academic centers in two countries were included. Technical success was defined as successful placement of a gastrojejunal lumen-apposing metal stent. Clinical success was defined as the ability of the patient to tolerate an oral diet. Post-procedural adverse events were recorded. RESULTS:The study included 26 patients, of whom 11 (42?%) were male. Technical success was achieved in 24 patients (92?%). Clinical success was achieved in 22 patients (85?%). Of the 4 patients in whom clinical success was not achieved, 2 had persistent nausea and vomiting despite a patent EUS-GJ and required enteral feeding for nutrition, 1 died before the initiation of an oral diet, and 1 underwent surgery for suspected perforation. Adverse events, including peritonitis, bleeding, and surgery, occurred in 3 patients (11.5?%). CONCLUSION:EUS-GJ is an emerging procedure that has efficacy and safety comparable with those of current therapies and should hold a place as a new minimally invasive option for patients with gastric outlet obstruction. Clinical trial identification number: NCT01522573.
Project description:Background and study aims ?Although endoscopic retrograde cholangiopancreatography (ERCP) is standard of care for malignant biliary obstruction, endoscopic ultrasound-guided biliary drainage (EUS-BD) as a primary treatment has become increasingly utilized. The aim of this study was to perform a systematic review and meta-analysis to evaluate the effectiveness and safety of EUS-BD for primary treatment of malignant biliary obstruction and comparison to traditional ERCP. Methods ?Individualized search strategies were developed through November 2018 using PRISMA and MOOSE guidelines. A cumulative meta-analysis was performed by calculating pooled proportions. Subgroup analysis was performed for studies comparing EUS-BD versus ERCP. Heterogeneity was assessed with Cochran Q test or I 2 statistics, and publication bias by funnel plot and Egger's tests. Results ?Seven studies (n?=?193 patients; 57.5?% males) evaluating primary EUS-BD for malignant biliary obstruction were included. Mean age was 67.4 years (2.3) followed an average of 5.4 months (1.0). For primary EUS-BD, pooled technical success, clinical success, and adverse event (AE) rates were 95?% (95?% CI 91?-?98), 97?% (95?% CI 93?-?100), and 19?% (95?% CI 11?-?29), respectively. Among EUS-BD and ERCP comparator studies, technical and clinical success, and total AEs were not different with lower rates of post-ERCP pancreatitis and reintervention among the EUS-BD group. Conclusion ?Primary EUS-BD is an effective treatment with few AE. Comparing EUS-BD versus ERCP, EUS-BD has comparable efficacy and improved safety as a primary treatment for malignant biliary obstruction. Further randomized trials should be performed to identify patient populations and clinical scenarios in which primary EUS-BD would be most appropriate.
Project description:BACKGROUND: The most frequent complication following gastroenterostomy (GE) for gastric outlet obstruction is delayed gastric emptying (DGE), which occurs in roughly 20% of patients. There is evidence that DGE may be linked to the longitudinal incision of the jejunum and that a transverse incision (cross-section GE) may decrease the incidence of DGE following GE. PATIENTS AND METHODS: In contrast to the orthodox GE, the jejunum is severed transversely up to a margin of 1.5 cm at the mesenteric border and the anastomosis is created with a single running suture. A Braun anastomosis is added 20-30 cm distally to the GE. Patients were followed prospectively with special regard to the occurrence of DGE. RESULTS: Between 1 August 1994 and 1 August 1998, 25 patients underwent cross-section GE, mostly because of an irresectable periampullary carcinoma. Eight patients exhibited clinical signs of gastric outlet obstruction preoperatively, while in 17 the GE was performed on a prophylactic basis. A biliary bypass was added in 15 patients. There was no disruption of the GE, but one patient died in hospital (4%). The nasogastric tube was withdrawn on the first postoperative day (range 0-6 days), a liquid diet was started on the fifth day (range 2-7 days) and a full regular diet was tolerated at a median of 9 days (6-14 days).The incidence of DGE was 4%: only the single patient who died fulfilled the formal criteria for DGE. DISCUSSION: In contrast to orthodox GE, DGE seems to be of minor clinical importance following cross-section GE. As the technique is easy to perform, is free of specific complications and leads to a low incidence of DGE, it should be considered as an alternative to conventional GE.
Project description:EUS-guided radiofrequency ablation (RFA) and ethanol ablation (EA) for pancreatic neuroendocrine tumors (PNETs) have recently been reported with good outcomes. We performed a systematic review and meta-analysis to evaluate the comparative effectiveness and safety of EUS-RFA and EUS-EA in the treatment of PNETs. A comprehensive search of multiple databases (through October 2020) was performed to identify studies that reported outcomes of EUS-RFA and EUS-EA of PNETs. Outcomes assessed included clinical success, technical success, and adverse events (AEs). A total of 181 (100 EUS-RFA, 81 EUS-EA) patients (60.7 ± 9.2 years) with 204 (113 EUS-RFA, 91 EUS-EA) PNETs (mean size 15.1 ± 4.7 mm) were included from 20 studies. There was no significant difference in the rates of technical success (94.4% [95% confidence interval (CI): 88.5-97.3, I<sup>2</sup> = 0] vs. 96.7% [95% CI: 90.8-98.8, I<sup>2</sup> = 0]; P = 0.42), clinical success (85.2% (95% CI: 75.9-91.4, I<sup>2</sup> = 0) vs. 82.2% [95% CI: 68.2-90.8, I<sup>2</sup> = 10.1]; P = 0.65), and AEs (14.1% [95% CI: 7.1-26.3, I<sup>2</sup> = 0] vs. 11.5% [95% CI: 4.7-25.4, I<sup>2</sup> = 63.5]; P = 0.7) between EUS-RFA and EUS-EA, respectively. The most common AE was pancreatitis with the rate of 7.8% and 7.6% (P = 0.95) for EUS-RFA and EUS-EA, respectively. On meta-regression, the location of PNETs in head/neck of pancreas (P = 0.03) was a positive predictor of clinical success for EUS-RFA. EUS-RFA and EUS-EA have similar effectiveness and safety for PNETs ablation. Head/neck location of PNETs was a positive predictor for clinical success after EUS-RFA.
Project description:Background and study aims ?Endoscopic ultrasound (EUS)-guided biliary drainage (BD) is increasingly used for distal malignant biliary obstruction, yet its safety and efficacy compared to endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD) remain unclear. We performed a meta-analysis to improve our understanding of the role of EUS-BD in this patient population. Methods ?We searched Embase, MEDLINE, CENTRAL, and ISI Web of Knowledge through September 2018 for randomized controlled trials (RCTs) comparing EUS-BD to ERCP-BD or PTBD as treatment of distal malignant biliary obstruction. Risk ratios (RRs) with 95?% confidence intervals (CIs) were combined using random effects models. The primary outcome was risk of stent/catheter dysfunction requiring reintervention. Results ?Of six trials identified, three (n?=?222) compared EUS-BD to ERCP-BD for first-line therapy; three others (n?=?132) evaluated EUS-BD versus PTBD after failed ERCP-BD. EUS-BD was associated with a decreased risk of stent/catheter dysfunction overall (RR, 0.39; 95?%CI 0.27?-?0.57) and in planned subgroup analysis when compared to ERCP (RR, 0.41; 95?%CI 0.23?-?0.74) or PTBD (RR, 0.37, 95?%CI 0.22?-?0.61). Compared to ERCP, EUS was associated with a decreased risk of post-procedure pancreatitis (RR, 0.12; 95?%CI 0.01?-?0.97). No differences were noted in technical or clinical success. Conclusions ?In a meta-analysis of randomized trials comparing EUS-BD to conventional biliary drainage modalities, no difference in technical or clinical success was observed. Importantly, EUS-BD was associated with decreased risks of stent/catheter dysfunction when compared to both PTBD and ERCP, and decreased post-procedure pancreatitis when compared to ERCP, suggesting the potential role for EUS-BD as an alternative first-line therapy in distal malignant biliary obstruction.
Project description:Endoscopic ultrasound-guided biliary drainage (EUS-BD) can be performed entirely transgastrically (hepatogastrostomy/EUS-HG) or transduodenally (choledochoduodenostomy/EUS-CDS). It is unknown how both techniques compare. The aims of this study were to compare efficacy and safety of both techniques and identify predictors of adverse events.Consecutive jaundiced patients with distal malignant biliary obstruction who underwent EUS-BD at multiple international centers were included. Technical/clinical success, adverse events, stent complications, and survival were assessed.A total of 121 patients underwent EUS-BD (CDS 60, HG 61). Technical success was achieved in 112 (92.56 %) patients (EUS-CDS 93.3 %, EUS-HG 91.8 %, P = 0.75). Clinical success was attained in 85.5 % of patients who underwent EUS-CDS group as compared to 82.1 % of patients who underwent EUS-HG (P = 0.64). Adverse events occurred more commonly in the EUS-HG group (19.67 % vs. 13.3 %, P = 0.37). Both plastic stenting (OR 4.95, 95 %CI 1.41 - 17.38, P = 0.01) and use of non-coaxial electrocautery (OR 3.95, 95 %CI 1.16 - 13.40, P = 0.03) were independently associated with adverse events. Length of hospital stay was significantly shorter in the CDS group (5.6 days vs. 12.7 days, P < 0.001). Mean follow-up duration was 151 ± 159 days. The 1-year stent patency probability was greater in the EUS-CDS group [0.98 (95 %CI 0.76 - 0.96) vs 0.60 (95 %CI 0.35 - 0.78)] but overall patency was not significantly different. There was no difference in median survival times between the groups (P = 0.36) CONCLUSIONS: Both EUS-CDS and EUS-HG are effective and safe techniques for the treatment of distal biliary obstruction after failed ERCP. However, CDS is associated with shorter hospital stay, improved stent patency, and fewer procedure- and stent-related complications. Metallic stents should be placed whenever feasible and non-coaxial electrocautery should be avoided when possible as plastic stenting and non-coaxial electrocautery were independently associated with occurrence of adverse events.
Project description:BACKGROUND & AIMS:Endoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); however, its growth has been limited by a lack of multicenter randomized controlled trials (RCT) and dedicated devices. A dedicated EUS-BD lumen- apposing metal stent (LAMS) has recently been developed with the potential to greatly facilitate the technique and safety of the procedure. We aim to compare a first intent approach with EUS-guided choledochoduodenostomy with a dedicated biliary LAMS vs. standard ERCP in the management of malignant distal biliary obstruction. METHODS:The ELEMENT trial is a multicenter single-blinded RCT involving 130 patients in nine Canadian centers. Patients with unresectable, locally advanced, or borderline resectable malignant distal biliary obstruction meeting the inclusion and exclusion criteria will be randomized to EUS-choledochoduodenostomy using a LAMS or ERCP with traditional metal stent insertion in a 1:1 proportion in blocks of four. Patients with hilar obstruction, resectable cancer, or benign disease are excluded. The primary endpoint is the rate of stent dysfunction needing re-intervention. Secondary outcomes include technical and clinical success, interruptions in chemotherapy, rate of surgical resection, time to stent dysfunction, and adverse events. DISCUSSION:The ELEMENT trial is designed to assess whether EUS-guided choledochoduodenostomy using a dedicated LAMS is superior to conventional ERCP as a first-line endoscopic drainage approach in malignant distal biliary obstruction, which is an important and timely question that has not been addressed using an RCT study design. TRIAL REGISTRATION:Registry name: ClinicalTrials.gov. Registration number: NCT03870386. Date of registration: 03/12/2019.