Stent placement for benign esophageal leaks, perforations, and fistulae: a clinical prediction rule for successful leakage control.

BACKGROUND AND STUDY AIMS: Sealing esophageal leaks by stent placement allows healing in 44 % - 94 % of patients. We aimed to develop a prediction rule to predict the chance of successful stent therapy. PATIENTS AND METHODS: In this multicenter retrospective cohort study, patients with benign upper gastrointestinal leakage treated with stent placement were included. We used logistic regression analysis including four known clinical predictors of stent therapy outcome. The model performance to predict successful stent therapy was evaluated in an independent validation sample. RESULTS: We included etiology, location, C-reactive protein, and size of the leak as clinical predictors. The model was estimated from 145 patients (derivation sample), and 59 patients were included in the validation sample. Stent therapy was successful in 55.9 % and 67.8 % of cases, respectively. The predicted probability of successful stent therapy was significantly higher in success patients compared with failure patients in both the derivation (P < 0.001) and validation (P < 0.001) samples. The area under the receiver operating characteristic curve was 74.1 % in the derivation sample and 84.7 % in the validation sample. When the model predicted ≥ 70 % chance of success, the positive predictive value was 79 % in the derivation sample and 87 % in the validation sample. When the model predicted ≤ 50 % chance of success, the negative predictive value was 64 % and 86 %, respectively. CONCLUSIONS: This prediction rule, consisting of four clinical predictors, could identify patients with esophageal leaks who were likely to benefit from or fail on stent therapy. The prediction rule can support clinical decision-making when the predicted probability of success is ≥ 70 % or ≤ 50 %.

Endoscopic full-thickness resection of gastric and duodenal subepithelial lesions using a new, flat-based over-the-scope clip.

BACKGROUND: Surgical 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. METHODS: Consecutive 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. RESULTS: eFTR 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%). CONCLUSIONS: eFTR 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.

Electromagnetic-guided placement of nasoduodenal feeding tubes versus endoscopic placement: a randomized, multicenter trial.

BACKGROUND AND AIMS: Electromagnetic-guided placement (EMP) of a nasoduodenal feeding tube by trained nurses is an attractive alternative to EGD-guided placement (EGDP). We aimed to compare EMP and EGDP in outpatients, ward patients, and critically ill patients with normal upper GI anatomy. METHODS: In 3 centers with no prior experience in EMP, patients were randomized to placement of a single-lumen nasoduodenal feeding tube either with EGDP or EMP. The primary endpoint was post-pyloric position of the tube on abdominal radiography. Patients were followed for 10 days to assess patency and adverse events. The analyses were performed according to the intention-to-treat principle. RESULTS: In total, 160 patients were randomized to EGDP (N = 76) or EMP (N = 84). Three patients withdrew informed consent, and no abdominal radiography was performed in 2 patients. Thus, 155 patients (59 intensive care unit, 38%) were included in the analyses. Rates of post-pyloric tube position between EGDP and EMP were comparable (79% vs 82%, odds ratio 1.16; 90% confidence interval, 0.58-2.38; P = .72). Adverse events were observed in 4 patients after EMP (hypoxia, GI blood loss, atrial fibrillation, abdominal pain) and in 4 after EGDP (epistaxis N = 2, GI blood loss, hypoxia). Costs of tube placements were lower for EMP compared with EGDP: $519.09 versus $622.49, respectively (P = .04). CONCLUSIONS: 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.).

Colorectal endoscopic full-thickness resection using a novel, flat-base over-the-scope clip: a prospective study.

Background and study aims We aimed to evaluate the feasibility and safety of a new, flat-based over-the-scope clip (Padlock Clip) for colorectal endoscopic full-thickness resection (eFTR). Patients and methods We prospectively included 26 patients with lesions < 20 mm. Indications for eFTR were re-resection of the scar of a low risk malignant polyp (n = 11), recurrent adenoma in a non-lifting scar (n = 10), non-lifting polyp (n = 4), and an adenoma located in a diverticulum (n = 1). Results Technical success rate and full-thickness resection rate were 100 % (26/26) and 92 % (24/26), respectively. Median procedure time was 43 minutes (IQR 27 - 56). No complications occurred during the procedure; 3 complications (12 %) occurred within 48 hours, of which one was a perforation requiring laparoscopic suturing. Specimen volumes from eFTR of scar tissue where the original polyp had been ≥ 20 mm (n = 13) were smaller compared with those from non-scar resections or scars where the original polyps had been < 20 mm (n = 13) (median 0.8 vs. 1.5 cm3, P = 0.03). Conclusions In this first series of colorectal eFTR using the Padlock Clip, feasibility was demonstrated. It was relatively safe in view of surgery as the alternative treatment, but could still benefit from technical refinement. Future studies should explore for which indication this technique is most suitable. TRIAL REGISTRATION: NTR5562 (Dutch Trial Register).

EUS-guided celiac ganglia neurolysis: a clinical and human cadaver study (with video).

BACKGROUND AND AIMS: There is little evidence that structures targeted during EUS-guided celiac ganglia neurolysis (EUS-CGN) are celiac ganglia and that selective ethanol injection into ganglia is feasible. We aimed to visualize celiac ganglia, confirm that these structures are ganglia, and visualize ethanol spread after EUS-CGN and EUS-guided celiac plexus neurolysis (EUS-CPN). METHODS: First, celiac ganglia were sought during 97 consecutive EUS procedures. Second, ganglia were identified in a prosected human cadaver by placing a linear echoendoscope next to the celiac trunk and removing the underlying tissue for histology. Finally, various EUS-CGN and EUS-CPN techniques were performed in human cadavers; EUS-CGN was performed with 1 mL ethanol in 1 ganglion, 1 mL per ganglion (both low volume), and 4 mL per ganglion (high volume). EUS-CPN was performed with a central (20 mL) and a bilateral (2*10 mL) approach. Transverse sections (75 µm) were obtained and photographed to allow visualization of the spread of ethanol. RESULTS: A total of 204 ganglia were detected in 83 patients. Mean (± standard deviation) size of the long axis was 8.1 mm (± 7.4 mm). Histology of the removed region in the cadaver showed only nerve cell bodies. After low-volume EUS-CGN in cadavers, ethanol spread well beyond the targeted ganglion. After high-volume EUS-CGN in cadavers, a larger ethanol spread was seen, which also reached unidentified ganglia; the spread was comparable to the spread after EUS-CPN. CONCLUSIONS: Specific EUS-CGN is not feasible because ethanol spreads well beyond the targeted ganglion. Unidentified celiac ganglia are better reached with high-volume EUS-CGN, and this would likely result in a more thorough neurolysis. High-volume EUS-CGN should be preferred to low-volume EUS-CGN.

Growth rate of small pancreatic neuroendocrine tumors in multiple endocrine neoplasia type 1: results from an endoscopic ultrasound based cohort study.

Background and aims In multiple endocrine neoplasia type 1 (MEN1), endoscopic ultrasound (EUS) is used for identification and follow-up of pancreatic neuroendocrine tumors (PNETs). The role of EUS in surveillance of small ( < 20 mm) PNETs is unclear, mostly because the natural course of these lesions is largely unknown. We aimed to determine annual growth and incidence rate of small PNETs in patients with MEN1 using EUS-based surveillance. Patients and methods Linear array EUS procedures in patients with MEN1 between 2002 and 2015 were identified. Number, size, and location of PNETs were recorded. Annual growth of PNETs < 20 mm identified at the initial EUS ("prevalent" PNETs) and during follow-up ("incident" PNETs) was calculated using mixed model linear regression analysis. Results A total of 54 patients were identified and 38 patients were included. In all, 226 PNETs were identified (median size 5.0 mm, interquartile range 3.7 - 7.5) of which 124 (55 %) were prevalent and 102 (45 %) were incident PNETs. Annual incidence rate was 0.79 PNETs/year (95 % confidence interval [CI] 0.73 to 0.87). Overall growth rate was 0.10 mm/year (95 %CI 0.02 to 0.19; P = 0.01); PNETs < 10 mm (n = 198) did not grow (P = 0.23), whereas PNETs ≥ 10 mm (n = 28) grew 0.44 mm/year (95 %CI 0.10 to 0.78; P = 0.01). Prevalent PNETs grew 0.21 mm/year (95 %CI 0.10 - 0.32; P < 0.001), whereas incident PNETs did not grow (P = 0.26). Conclusions The annual growth rate of small, solid PNETs in patients with MEN1 is lower than previously thought. Surveillance intervals could probably be prolonged without compromising safety.

Challenges in oral drug delivery in patients with esophageal dysphagia.

INTRODUCTION: Esophageal dysphagia is a commonly reported symptom with various benign and malignant causes. Esophageal dysphagia can impede intake of oral medication, which often poses a major challenge for both patients and physicians. The best way to address this challenge depends of the cause of dysphagia. AREAS COVERED: The pathophysiology of esophageal dysphagia is discussed, diagnostic tools to determine its cause are reviewed and recent developments in the treatment of esophageal dysphagia are discussed. Alternative options to administer medication in dysphagia are discussed and the appropriateness of them reviewed. EXPERT OPINION: Two ways can be followed to allow medication intake in patients with esophageal dysphagia, i.e. altering medication or resolving dysphagia. The latter is generally preferred, since esophageal dysphagia rarely only impedes medication intake. Esophageal resection is possible in more advanced esophageal cancer stages due to advances in neo-adjuvant therapy. Due to recent improvements in intraluminal radiotherapy, it can be expected that this will be the primary treatment in a palliative setting. Temporary self-expandable metal stent placement is a promising new alternative for bougienage in difficult-to-treat benign strictures.

Esophagogastric junction distensibility measurements during hydraulic dilation therapy in achalasia patients.

Increasing evidence suggests that esophagogastric junction (EGJ) distensibility is predictive of long-term clinical success after achalasia treatment. A new commercially available hydraulic dilation balloon is capable of measuring EGJ opening diameters whilst simultaneously dilating the EGJ. Deployed alongside the endoscope under direct visualization, it is used for dilation of the lower esophageal sphincter in patients with achalasia. Impedance measurement electrodes are incorporated in the catheter shaft in the dilation balloon, which allows measuring the diameter of the EGJ and displaying it in real time before, during and after dilation. This obviates the need for fluoroscopy during the dilation procedure. The extent of recoil of the EGJ after dilation potentially provides a measurement that could be incorporated into a clinical rule for predicting therapeutic success after dilation.

Hydraulic dilation with a shape-measuring balloon in idiopathic achalasia: a feasibility study.

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 (mm(2)/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.