Green Tea Extract to Prevent Colorectal Adenomas, Results of a Randomized, Placebo-Controlled Clinical Trial.

INTRODUCTION: Preclinical, epidemiological, and small clinical studies suggest that green tea extract (GTE) and its major active component epigallocatechingallate (EGCG) exhibit antineoplastic effects in the colorectum. METHODS: A randomized, double-blind trial of GTE standardized to 150 mg of EGCG b.i.d. vs placebo over 3 years was conducted to prevent colorectal adenomas (n = 1,001 with colon adenomas enrolled, 40 German centers). Randomization (1:1, n = 879) was performed after a 4-week run-in with GTE for safety assessment. The primary end point was the presence of adenoma/colorectal cancer at the follow-up colonoscopy 3 years after randomization. RESULTS: The safety profile of GTE was favorable with no major differences in adverse events between the 2 well-balanced groups. Adenoma rate in the modified intention-to-treat set (all randomized participants [intention-to-treat population] and a follow-up colonoscopy 26-44 months after randomization; n = 632) was 55.7% in the placebo and 51.1% in the GTE groups. This 4.6% difference was not statistically significant (adjusted relative risk 0.905; P = 0.1613). The respective figures for the per-protocol population were 54.3% (151/278) in the placebo group and 48.3% (129/267) in the GTE group, indicating a slightly lower adenoma rate in the GTE group, which was not significant (adjusted relative risk 0.883; P = 0.1169). DISCUSSION: GTE was well tolerated, but there was no statistically significant difference in the adenoma rate between the GTE and the placebo groups in the whole study population.

VACStent: Combining the benefits of endoscopic vacuum therapy and covered stents for upper gastrointestinal tract leakage.

Background and study aims Endoscopic treatment has markedly improved the high morbidity and mortality in patients with upper gastrointestinal tract leakage. Most procedures employ either covered self-expanding metal stents (SEMS) or endoscopic vacuum therapy (EVT), both with good clinical success but also with concomitant significant shortcomings inherent in each technique. A newly developed device, the VACStent, combines the fully covered SEMS with a polyurethane sponge cylinder anchored on the outside. This allows endoluminal EVT while keeping the intestinal lumen patent. The benefit is prevention of stent migration because the suction force of the sponge-cylinder immobilizes the VACStent on the intestinal wall, while at the same time, the attached external vacuum pump suctions off any secretions and improves healing with negative-pressure wound treatment (NPWT). Patients and methods In this pilot study, the first patients to receive the VACStent were assessed. Outcomes included the applicability and stability of the VACStent system together with the clinical course. Results Three patients with different clinical courses were managed with the VACStent. The first patient suffered anastomotic leakage following subtotal esophagectomy and was successfully treated with two postoperative VACStents for 12 days. The second patient received a covered SEMS for 14 days for acute Boerhaave syndrome. Due to persistent leakage, management was converted to EVT. Seven days, later a VACStent was inserted to allow oral nutrition while the leak finally closed. In the third patient, a LINX Reflux Management System had to be removed for erosion, leaving the gastroesophageal junction (GEJ) with a full-thickness gap. After VACstent insertion, successful closure was achieved within 4 days. Conclusions These clinical cases demonstrate the applicability and efficacy of the VACstent in management of esophageal and anastomotic leakage. With its vacuum sponge, the stent fosters wound healing while the covered SEMS keeps the passage patent for nutrition.

Diagnostic and therapeutic single-operator cholangiopancreatoscopy with SpyGlassDS™: results of a multicenter retrospective cohort study.

BACKGROUND AND AIMS: The aim of the study was to evaluate the usefulness and diagnostic and therapeutic outcome of the single-operator cholangiopancreatoscopy (SOC) with SpyGlassDS™. METHODS: In a retrospective multicenter study between November 2015 and January 2017, SpyGlassDS™ procedures were analyzed in participating centers. Indications, accuracy of SOC-guided biopsies, management of large bile duct stones, and complications were analyzed. Follow-up was 4 months. RESULTS: Two hundred and six patients out of 250 examinations were evaluated. Indications were biliary stones (n = 132), bile duct stenosis (n = 93), stones and stenosis combined (n = 24), and bile duct leakage (n = 1). Of the 117 cases which were suspicious of malignancy, in 99 cases the lesion could be stratified into benign (n = 55) or malignant (n = 44) indicating a sensitivity of 95.5% and a specificity of 94.5% for the indication tumor. SOC-guided biopsies revealed a sensitivity of 57.7% with a specificity of 100%. In 107 examinations, biliary stones were visualized and could be completely removed in 91.1% with a need of three procedures (range 1-6) to achieve final stone clearance. In 75 cases, lithotripsy was performed and was successful in 71 cases (95%). Four out of 45 patients (8.9%) underwent cholecystectomy with surgical bile duct revision as a final therapy. Adverse Event (AE) occurred in 33/250 patients (13.2%) and Serious Adverse Event (SAE) occurred in 1/250 patients (0.4%). Cholangitis was 1% (n = 102) after peri-interventional administration of antibiotics and 12.8% (n = 148) without antibiotic prophylaxis (p < 0.001). CONCLUSIONS: SOC with SpyGlassDS™ became a new standard for the diagnosis of indefinite biliary lesions and therapy of large bile duct stones. The diagnostic yield of SOC-guided biopsies facilitated a definite diagnosis in most cases and should be improved by standardized biopsy protocols. SOC-guided interventions allowed removal of large biliary stones by SOC-guided lithotripsy. The complication rate of 13.2% can be considerably reduced by use of a single-shot antibiotic treatment.