BackgroundSurgical resection of upper gastrointestinal (GI) subepithelial tumors (SETs) is associated with significant morbidity and mortality. A new over-the-scope (OTS) clip can be used for endoscopic full-thickness resection (eFTR). We aimed to prospectively evaluate feasibility and safety of upper GI eFTR with a new, flat-based OTS clip.MethodsConsecutive patients with a gastric or duodenal SET < 20 mm were prospectively included. After identification of the lesion, the clip was placed and lesions were resected. Patients were followed for 1 month to assess severe adverse events (SAEs); 3–6 months after eFTR, endoscopy was performed.ResultseFTR was performed on 13 lesions in 12 patients: 7 gastric and 6 duodenal SETs. Technical success was achieved in 11 cases (85%). In all 11 cases, R0-resection was achieved. In all 6 duodenal cases and in one gastric case, FTR was achieved (64%). One SAE (pain) was observed after eFTR of a gastric SET. After eFTR of duodenal SETs, several SAEs were observed: perforation (n = 1), microperforation (n = 3), and hemorrhage (n = 1). During follow-up endoscopy, the clip was no longer in situ in most patients (7 of 10; 70%).ConclusionseFTR with this new flat-based OTS clip is feasible and effective. Although gastric eFTR was safe, eFTR in the duodenum was complicated by (micro)perforation in several patients. Therefore, the design of the clip or the technique of resection needs further refinement to improve safety of resection of SET in thin-walled areas such as the duodenum before being applied in clinical practice.Dutch trial register: NTR5023.Electronic supplementary materialThe online version of this article (10.1007/s00464-017-5989-8) contains supplementary material, which is available to authorized users.
Summary
Background
A previous single‐centre study showed that lower oesophageal sphincter electrical stimulation therapy (LES‐EST) in gastro‐oesophageal reflux disease (GERD) patients improves reflux symptoms and decreases oesophageal acid exposure.
Aim
To evaluate safety and efficacy of LES‐EST in GERD patients with incomplete response to proton pump inhibitors (PPIs) in a prospective, international, multicentre, open‐label study.
Methods
GERD patients, partially responsive to PPIs, received LES‐EST. GERD health‐related quality of life (GERD‐HRQL), daily symptom diaries, quality of life scores, oesophageal acid exposure, and LES resting and residual pressure were measured before and after initiation of LES‐EST. Stimulation sessions were optimised based on residual symptoms and oesophageal acid exposure.
Results
Forty‐four patients were enrolled and 6‐month data from 41 patients are available. Hiatal repair was performed in 16 patients. One device‐related, one procedure‐related and one unrelated severe adverse event were reported. GERD‐HRQL improved from 31.0 (IQR 26.2–36.8) off‐PPI and 16.5 (IQR 9.0–22.8) on‐PPI to 4 (IQR 1–8) at 3‐month and 5 (IQR 3–9) at 6‐month follow‐up (P < 0.0001 vs. on‐ and off‐PPI). Oesophageal acid exposure (pH < 4.0) improved from 10.0% (IQR 7.5–12.9) to 3.8% (IQR 1.9–12.3) at 3 months (P = 0.0027) and 4.4% (IQR 2.2–7.2) at 6 months (P < 0.0001).
Conclusions
These interim results show an acceptable safety record of LES‐EST to date, combined with good short‐term efficacy in GERD patients who are partially responsive to PPI therapy. A remarkable reduction in regurgitation symptoms, without the risk of intervention‐requiring dysphagia may prove to be an advantage compared with other anti‐reflux procedures. ClinicalTrials.gov Identifier: NCT01574339.
Diagnostic yield and accuracy of EUS-FNA of mediastinal and abdominal lymph nodes with and without ROSE are comparable. Time needed to review slides was shorter and post-procedural pain was less often reported in the ROSE+ group. Based on the primary outcome, the implementation of ROSE during EUS-FNA of mediastinal and abdominal lymph nodes cannot be advised. (Dutch Trial Register: NTR4876).
Success rates and safety of EMP and EGDP in patients with normal upper GI anatomy were comparable. Lower costs and potential logistic advantages may drive centers to adopt EMP as their new standard of care. (Clinical trial registration number: NTR4286.).
Background and aim: Pneumatic dilation is a commonly used treatment in achalasia. Recent studies have shown that esophageal distensibility measurements can be used to assess the effect of dilation and possibly the risk of perforation. A new hydraulic dilation balloon allows visualization of the shape of the balloon in vivo and measurement of distensibility during dilation. We aimed to evaluate the technical feasibility of a 30-mm shape-measuring hydraulic dilation balloon for the treatment of achalasia.
Methods: Consecutive patients with newly diagnosed achalasia were dilated using a 30-mm shape-measuring hydraulic dilation balloon. Patients were contacted 1 week, 1 month, and 3 months after dilation. Technical success, clinical success, and major complications were evaluated.
Results: Technical success was achieved in all of the 10 patients included. Median esophagogastric junction distensibility (mm2/mmHg) increased from 1.1 (IQR 0.6???1.3) before dilation therapy to 7.0 (IQR 5.5???17.8) afterwards (P?=?0.005). No major complications were seen. Three patients (30?%) reported recurrent dysphagia.
Conclusion: Hydraulic dilation with a shape-measuring balloon in achalasia patients is feasible. In vivo esophageal distensibility measurements may allow for an individualized, patient-specific dilation regimen.
The Netherlands National Trial Register: NTR4371
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