Conference Highlights: DDW 2016

Conference Highlights: DDW 2016
New research was presented at DDW 2016, the annual Digestive Disease Week conference, from May 22 to 24 in San Diego.
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Treating Diabetes With Self-Assembling Magnets
For a study, researchers evaluated the endoscopic creation of a dual-path enteral diversion using the incisionless anastomosis system—a procedure that involves self-assembling magnets—in patients with type 2 diabetes and obese patients in the pre-diabetic range. At 6 months, investigators observed that all patients experienced significant reductions in HbA1c and fasting blood glucose levels. Patients with type 2 diabetes showed a decrease of HbA1c from a mean baseline of 7.8 percent to 6.0 percent at six months, with a decrease in fasting blood glucose levels from 177 mg/dl to 111mg/dl. For patients with pre-diabetes, HbA1c levels were reduced from a mean baseline of 6.1 percent to 5.25 percent at six months, and fasting blood glucose levels decreased from 119 mg/dl to 105 mg/dl. The mean weight loss for all patients was approximately 28 pounds (12.9 kg), representing a 10.6 percent decrease in total weight loss.


Detecting Esophageal Precancer
New final study results demonstrate that the use of the WATS3D (wide area transepithelial sampling with 3D tissue analysis) biopsy increased the detection of high-grade dysplasia and esophageal adenocarcinoma (HGD/EAC) four times more than the standard forceps biopsy (FB) method. In the multicenter, prospective study conducted at 14 major academic GI centers, 160 high-risk patients undergoing Barrett’s esophagus surveillance received both Seattle protocol random FB and WATS3D. WATS3D found 4.1 times more HGD/EAC than the Seattle protocol random biopsies; detecting 29 cases of HGD/EAC, while the Seattle random FB detected only 7 such cases. Seattle random biopsy protocol detected 7 cases of HGD/EAC, 6 of which were also detected by WATS3D, with the remaining case reported by WATS3D as indefinite for dysplasia/low-grade dysplasia (IND/LGD). WATS3D found an additional 23 cases of HGD/EAC not detected on FB (12 were reported by FB as IND/LGD, while 11 were reported by FB as non-dysplastic Barrett’s esophagus (NDBE) only). All cases of WATS3D-discovered HGD/EAC that were not found on FB were then subjected to a second blinded independent review by two central Cleveland Clinic pathologists, requiring unanimous confirmation of the WATS3D finding using standard pathologic criteria.


Incisionless Procedure Proves Effective for Refractory GERD
Endoscopic full thickness fundoplasty (EFTF) has been shown to be beneficial to patients who suffer from persistent GERD. A recent clinical study concludes that ultrasound-assisted EFTF is a safe and promising alternative to surgical fundoplication for treatment of patients who are intolerant of medical treatment, specifically those who are unwilling or unable to take PPIs, or who are refractory to PPI therapy. At the time of the study, three participants had reached their 6 month post-procedure mark and all three demonstrated a >50% improvement in GERD-HRQL scores and a significant reduction in time (average percent total and upright) pH<4 as well as a reduction in total number of reflux episodes.


Preparation-Free Colon Screening
Results of a study evaluating an ingestible capsule for preparation-free, colorectal cancer screening demonstrated safe and complete passage for the 75 participants enrolled in a completed study to assess the natural motility of the capsule. Additionally, a preliminary analysis of an ongoing clinical feasibility study evaluated data from 54 participants who swallowed Check-Cap’s scanning capsule, tracking the passage of the capsule through the alimentary tract using radio frequency telemetry and Check-Cap’s proprietary capsule position tracking system. Capsule passage was safe and well tolerated, with an average transit time of 66 ±37 hours observed in 53 volunteers who completed the study (one asymptomatic volunteer withdrew prior to completion and the capsule was retrieved endoscopically from the colon), and the total radiation dose was found to be ultra-low (0.03±0.007 mSv, or the equivalent exposure of one dental or chest x-ray). Three-dimensional image reconstructions of the colonic wall and lumen detected and located small and large pedunculated and sessile polyps, as validated by subsequent colonoscopy.


Cryoballoon Ablation for Barrett’s Esophagus
Results were presented describing a single-center, prospective, single-arm clinical trial of cryoballoon ablation in patients with Barrett’s esophagus (BE) found an overall complete response rate for all dysplasia and cancer of 95%. The overall complete response rate for intestinal metaplasia was 71%. No serious adverse events were noted, including perforations or bleeding and no patient had a persistent symptomatic stricture. Three patients developed mild inflammatory stenosis, all of which resolved. Study investigators concluded that nitrous cryoballoon ablation is a promising, safe, and potentially effective endoscopic intervention for BE-associated neoplasia.

A second study described results from a single center case-series of patients with esophageal neoplasia. Cryoablation was used to treat residual BE in the esophagus in 7 patients, and 10 patients were treated for residual or recurrent disease at the GE junction. There were no intraprocedural complications. Twelve patients (10 BE) had at least one follow up endoscopy. Overall, 60 percent of patients had complete resolution, with no new strictures noted in any of the patients.


Cryoballoon Ablation Well-Tolerated & Safe for ESCN
Study investigators have reported the first application of successful cryoballoon ablation for curative treatment of primary or recurrent esophageal squamous cell neoplasia (ESCN). Of nine patients (4 treatment-naïve and 5 previously treated) enrolled, squamous regeneration was seen in all treated areas, with complete pathologic response achieved in 5 evaluable patients who had completed therapy and had at least 1 post-treatment biopsy (mean follow-up time of 9.1 months). No major adverse events occurred and no strictures or bleeding developed. Median procedure time was 34 minutes and treatment was completed in all patients despite a single occurrence of minor device malfunction.


Cryoballoon May Completely Eradicate Barrett’s Esophagus
Preliminary results from an ongoing, prospective trial of cryoballoon ablation in patients with dysplastic BE or residual BE after removal of early cancer were presented during DDW 2016. In this study, areas of dysplastic tissue, known as BE islands, or a group of BE islands were treated follow-up endoscopy performed 6-8 weeks following treatment. Of the 26 patients evaluated, 13 had low-grade dysplasia (LGD), 5 had high-grade dysplasia (HGD), and 8 had early carcinoma; 20 patients had undergone radiofrequency ablation prior to entering the study. In 25 of 26 patients who had undergone follow-up endoscopy, complete eradication was observed in 100 percent of BE islands that had been completely ablated during cryoballoon treatment; No buried glands were found on biopsy. No adverse events occurred during the procedure.


Transoral Incisionless Fundoplication for GERD
In a never-before-performed meta-analysis, Lauren Gerson, researchers presented results demonstrating that transoral incisionless fundoplication (TIF) significantly improves patients’ quality of life (HRQL) while reducing their reliance on proton pump inhibitors (PPIs). Patients who had the TIF procedure experienced a significant reduction in GERD-HRQL scores compared with patients treated with PPIs. The pooled prevalence for complete discontinuation of PPI therapy was 70%. Post-TIF procedure, a greater number of patients had reduction of distal esophagus acid exposure and healing of erosive esophagitis. For the meta-analysis, Drs. Gerson and Trad used research databases PubMed, Embase, and SCOPUS to examine data from three RCTs and seven cohort studies from the past eight years that examined the TIF procedure and outcomes at least six months after the procedure.

Effectiveness of Capnography Patient Monitoring for Endoscopic Procedures
For a recent systematic review and meta-analysis study, researchers—believing the current standard of care (SOC; ie, pulse oximetry and visual assessment) for detecting severe oxygen desaturation during endoscopic procedures may be insufficient—examined how the current SOC could be improved with the addition of capnography. The results of the study, which examined data from seven previous studies involving 1,344 patients, demonstrated that capnography may reduce the odds of severe oxygen desaturation by over 50%. Severe oxygen desaturation can lead to respiratory compromise, the second-most frequently occurring preventable safety issue. The study’s investigators concluded that there existed clear, consistent evidence that adding capnography to the SOC reduces the likelihood of respiratory compromise in the form of clinically significant hypoxemia during sedation for gastrointestinal procedures.


The above content was contributed by Lazar Partners.

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