Wouter Kappelle

Electrical stimulation therapy of the lower oesophageal sphincter for refractory gastro-oesophageal reflux disease - interim results of an international multicentre trial.

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.

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.

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 %.

Challenges in oral drug delivery in patients with esophageal dysphagia

ABSTRACT 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.

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).

Rapid on-site evaluation during endoscopic ultrasound-guided fine-needle aspiration of lymph nodes does not increase diagnostic yield: A randomized, multicenter trial

OBJECTIVES: Studies on the impact of rapid on‐site evaluation (ROSE) during endoscopic ultrasound‐guided fineneedle aspiration (EUS‐FNA) of lymph nodes are retrospective and have shown conflicting results. We aimed to compare the diagnostic yield of EUS‐FNA of lymph nodes with ROSE (ROSE+) and without ROSE (ROSE‐). METHODS: This was a multicenter, randomized controlled trial. Consecutive patients who were scheduled to undergo EUS‐FNA of mediastinal or abdominal lymph nodes were randomized to ROSE+ or ROSE‐. In the ROSE+ group, the number of passes was dictated by the on‐site cytotechnician. In the ROSE‐ group, five passes were performed without interference from the cytotechnician. All samples were reviewed by a single‐expert cytopathologist, blinded to group allocation. Primary endpoint was diagnostic yield with and without ROSE. RESULTS: After inclusion of 90 patients, interim analysis showed futility of study continuation since diagnostic yield of ROSE+ and ROSE‐ were comparable. A total of 91 patients were randomized to ROSE+ (N = 45) or ROSE‐ (N = 46). Diagnostic yield of ROSE+ and ROSE‐ and diagnostic accuracy were comparable: 93.3% vs. 95.7% (P = 0.68) and 97.6% vs. 93.2% (P = 0.62), respectively. Two major complications (one per group) occurred (p = 0.99). ROSE‐ patients more often reported selflimiting post‐procedural pain (p < 0.001). Median procedure time for ROSE+ (20 min) and ROSE‐ (23 min) was comparable (P = 0.06). Median time to review slides in the ROSE‐ group (12:47 min) was longer than with ROSE+ (7:52 min) (P < 0.001). Mean costs of ROSE‐ and ROSE+ were comparable: &U20AC;938.29 (±172.70) vs. &U20AC;945.98 (±223.38) (P = 0.91), respectively. CONCLUSIONS: 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)

Palliative treatment of malignant dysphagia : Stent by and await further instructions

Interestingly, the authors found that a longer stent reduces the risk of a severe adverse event, which is a very remarkable finding. Because the univariate analyses are not provided in the article, it is difficult to explain this unexpected outcome. Self-expandable metal stent (SEMS) placement is a fairly simple way to provide adequate and rapid relief of malignant dysphagia. Over the years, stents have evolved from rigid plastic tubes to partially or fully covered SEMSs; as a result, SEMSs have gained widespread acceptance as a palliative therapeutic procedure for malignant strictures. In many parts of the world, SEMS placement is currently still the preferred palliative treatment for malignant dysphagia, especially in patients with a short life expectancy. Unfortunately, the success of SEMS placement is not without downsides. Whereas partially covered SEMSs struggle with tumor or hyperplastic tissue ingrowth through uncovered mesh, which may lead to recurrent dysphagia, fully covered SEMSs are associated with a higher risk of migration because of a lack of anchoring capacity. Furthermore, the risk of major stent-related adverse events, such as hemorrhage, fistula formation, perforation, and severe retrosternal pain, is an important disadvantage of esophageal SEMS placement. Manufacturers, together with physicians, are constantly adjusting stent designs in an attempt to reduce the risk of major adverse events. Although many earlier studies of SEMS placement were case series or uncontrolled studies, nowadays more randomized trials are being conducted, providing us with a higher level of evidence about the safety of esophageal SEMS placement. In this issue of Gastrointestinal Endoscopy, Fuccio et al report on their retrospective analysis of factors associated with the occurrence of major adverse events after SEMS placement for malignant esophageal strictures and their attempt to create a model to predict such adverse events. The authors found that neoadjuvant chemotherapy and/or radiation therapy (CRT) increased the risk of a severe adverse event (SAE). Interestingly, contradictory to the findings of all (controlled) trials published thus far, the authors also report that placement of longer stents decreased the risk of an SAE, independently of any other factor except CRT, such as tumor length or tumor location. Furthermore, the authors state that stent length was not correlated with tumor length. So, should we believe the numerous

Esophagogastric junction distensibility measurements during hydraulic dilation therapy in achalasia patients

SUMMARY 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.