Flexible endoscopy assisted by Ligasure™ for treatment of Zenker's diverticulum: an effective and safe procedure.

BACKGROUND: Flexible endoscopy allows use of the vessel-tissue sealer Ligasure™ (Covidien, Massachusetts, USA) to perform diverticulotomy. Few studies have used this endoscopic approach in the uncommon disorder Zenker's diverticulum. The aim of the present study was to evaluate the effectiveness and safety of flexible endoscopy treatment assisted by Ligasure™. METHODS: The single-center prospective and descriptive study included patients treated by flexible endoscopy using Ligasure™ for resection of Zenker's diverticulum. Consecutive patients were included from March 2009 to April 2018. Patients were censored until the end of follow-up or death. Complications, symptoms before treatment, type of sedation, and number of interventions needed to resolve Zenker's diverticulum were analyzed. Bleeding complications were considered when a case required a second endoscopy. RESULTS: A total of 46 symptomatic patients with Zenker's diverticulum were included in the final analysis (41.3% women, median age of 73.7 ± 11 years). The median follow-up period was 37.21 ± 28 months. Of all cases, 58.7% were considered small (< 3 cm). Solid or semi-solid food-related dysphagia was present in 55.6% of patients previously to the procedure. The technique was successful in a single procedure in 78.3% of cases. However, the success rate increased to 89.1% with a second procedure, and we had a complication rate of 4.3% with this technique. Most patients (79.66%) were managed as out-patients or with short (< 24 h) admission. CONCLUSION: In this large case series, treatment of Zenker's diverticulum based on flexible endoscopy assisted by Ligasure™ was a safe and effective procedure with a high success rate in a few endoscopy sessions and low complication rate.

Short- and long-term clinical outcomes of self-expandable metal stents inserted for colorectal obstruction and efficacy of different insertion techniques.

OBJECTIVES: (1) To evaluate the short- and long-term clinical outcomes of patients after colorectal stent placement and (2) to assess the safety and efficacy of the stents for the resolution of colorectal obstruction according to the insertion technique. METHODS: Retrospective cohort study which included 177 patients with colonic obstruction who underwent insertion of a stent. RESULTS: A total of 196 stents were implanted in 177 patients. Overall, the most common cause of obstruction was colorectal cancer (89.3%). Ninety-two stents (47%) were placed by radiologic technique and 104 (53%) by endoscopy under fluoroscopic guidance. Technical success rates were 95% in both groups. Clinical success rates were 77% in the radiological group and 81% in the endoscopic group (p>0.05). The rate of complications was higher in the radiologic group compared with the endoscopic group (38% vs 20%, respectively; p=0.006). Among patients with colorectal cancer (158), 65 stents were placed for palliation but 30% eventually required surgery. The multivariate analysis identified three factors associated with poorer long-term survival: tumor stage IV, comorbidity and onset of complications. CONCLUSIONS: Stents may be an alternative to emergency surgery in colorectal obstruction, but the clinical outcome depends on the tumor stage, comorbidity and stent complications. The rate of definitive palliative stent placement was high; although surgery was eventually required in 30%. Our study suggests that the endoscopic method of stent placement is safer than the radiologic method.

Accuracy of the Ultra-Rapid Urease Test for diagnosis of Helicobacter pylori infection.

BACKGROUND: Rapid Urease Test (RUT) is a simple, cheap and relatively fast method for diagnosing Helicobacter pylori infection. It is therefore the preferred method used for patients undergoing gastroscopy. Most kits require 24h to give results. The new Ultra-Rapid Urease Test (URUT) kit by Biohit® requires less than 1h. OBJECTIVE: To determine URUT's diagnostic accuracy. METHOD: Prospective, blind, multi-centre study involving dyspeptic patients. One corpus biopsy and three antral biopsies were obtained during gastroscopy for standard histological analysis, RUT and URUT. The URUT result was checked after 1min, 5min, 30min and 60min and the RUT was checked over the course of 24h. Histology was used as the gold standard test. RESULTS: 144 patients were included, 68% female, with a mean age of 49 years old; 50% were H. pylori positive. RUT and URUT diagnoses were correct in 85.9% and 90% of the cases, respectively. The mean waiting time for a positive RUT result was 6h. The sensitivity, specificity, and positive and negative predictive values for RUT were, respectively, 82%, 90%, 89% and 84%. The URUT's results were similar (85%, 94%, 94% and 87%). These figures improved when patients taking PPIs were excluded (RUT: 86%, 91%, 93% and 83%; URUT: 91%, 94%, 96% and 89%). No statistically significant differences were found when comparing RUT and URUT distributions of correct diagnoses (McNemar's Test, p=0.3) but there was a tendency towards better results with the URUT. CONCLUSION: The URUT is equivalent to (or slightly better than) the traditional RUT in diagnosing H. pylori infection, and provides results in less than an hour.

Randomised clinical trial comparing sequential and concomitant therapies for Helicobacter pylori eradication in routine clinical practice.

OBJECTIVES: No trial has compared non-bismuth quadruple 'sequential' and 'concomitant' regimens in settings with increasing clarithromycin rates. The study aims to compare the effectiveness and safety of these therapies for Helicobacter pylori treatment. DESIGN: Prospective randomised clinical trial in 11 Spanish hospitals. Patients naïve to eradication therapy with non-investigated/functional dyspepsia or peptic ulcer disease were included. Randomised (1:1) to sequential (omeprazole (20 mg/12 h) and amoxicillin (1 g/12 h) for 5 days, followed by 5 days of omeprazole (20 mg/12 h), clarithromycin (500 mg/12 h) and metronidazole (500 mg/12 h)), or concomitant treatment (same drugs taken concomitantly for 10 days). Eradication was confirmed with (13)C-urea breath test or histology 4 weeks after treatment. Adverse events (AEs) and compliance were evaluated with questionnaires and residual medication count. RESULTS: 338 consecutive patients were randomised. Mean age was 47 years, 60% were women, 22% smokers and 20% had peptic ulcer. Concomitant and sequential eradication rates were, respectively, 87% vs 81% by intention-to-treat (p=0.15) and 91% vs 86% (p=0.131) per protocol. Respective compliances were 83% vs 82%. Treatment-emergent AEs were reported in 59% of patients (no differences found between treatments). AEs were mostly mild (60%), and average length was 6.1 days, causing discontinuation only in 12 patients. Multivariate analysis: 'concomitant' treatment showed an OR of 1.5 towards better eradication rate in a borderline significance CI (95% CI 0.9 to 2.8). CONCLUSIONS: Concomitant therapy led to a non-statistically significant advantage (5%) over sequential therapy, coming closer to 90% cure rates. Both therapies showed an acceptable safety profile. ClincialTrials.gov: NCT01273441.

[Helicobacter pylori resistance to metronidazole and clarythromicin: descriptive analysis 1997-2000]. / Resistencia de Helicobacter pylori al metronidazol y a la claritromicina: análisis descriptivo entre 1997 y 2000.

BACKGROUND AND OBJECTIVE: We aimed to assess the resistance of H. pylori to clarithromycin and metronidazole, in patients with and without previous eradication treatment, in a geographic area from the north of Spain. We also analyzed the evolution of resistance rates and its relationships with annual antibiotic consumption. PATIENTS AND METHOD: Retrospective study including all patients with H. pylori infection and positive culture from January 1997 to December 2000. Minimal inhibitory concentrations (MIC) determined by the E test were used to report the clarithromycin (MIC > 2 mg/l) and metronidazole (MIC > 32 mg/l) resistance. RESULTS: A total of 537 clinical H. pylori isolates from patients without (n = 389) and with previous eradication treatment (n = 148) were studied. H. pylori resistance to clarithromycin and metronidazole was found in 8.7% (95% CI, 6.1-12) and 13.8% (95% CI, 10.4-17.3) patients without previous eradication treatment and in 39.2% (95% CI, 31.3-47.1) and 37.8% (95% CI, 30-45.7) patients with previous eradication treatment (p < 0.001), respectively. Clarithromycin resistance remained stable (1997: 9.7%; 1998: 5.7%; 1999: 11.8%; 2000: 6.2%) whereas metronidazole resistance decreased over the 4 years study period (1997: 38.7%; 1998: 15.1%; 1999: 9%; 2000: 6.9%). We did not observe any clear relationship between resistance's evolution and antibiotic annual consumption. CONCLUSIONS: In our geographic area, primary resistance rates for clarithromycin remained stable whereas resistance for metronidazole decreased over the 4 years period.

Use of self-expanding metal stents to treat malignant colorectal obstruction in general endoscopic practice (with videos).

BACKGROUND: Self-expanding metal stents (SEMS) are being increasingly used to solve malignant colorectal obstruction (MCRO). Patients can then either undergo scheduled surgery or have the stent left in place as a definitive palliative treatment. The majority of reports on the use of SEMS in MCRO come from single centers; therefore, its use in general endoscopic practice is not clearly known. OBJECTIVE: To study the use of SEMS for MCRO in a wide endoscopic practice. DESIGN: Retrospective study. SETTING: A survey was carried out among endoscopists in 13 hospitals in Spain (6 tertiary referral centers and 7 community hospitals). PATIENTS: Those who presented with MCRO. INTERVENTIONS: A total of 175 attempts to insert colorectal SEMS were made during a 12-month period (October 2003 to September 2004). MAIN OUTCOME MEASURES: Technical and clinical success and possible differences according to the type of hospital. RESULTS: There was a mean of 1.2 attempts/mo per center (range, 2-0.5 attempts/mo per center). Insertion success was achieved in 162 (92.6%) and acceptable colonic decompression in 138 of 175 (78.8%) attempts and in 138 of 162 (85.1%) of successfully inserted stents. SEMS served as a bridge to scheduled surgery in 72 of 175 (41%) and as a palliative definitive treatment in 66 of 175 (37.7%). The major complication was perforation, which occurred in 7 of 175 occasions (4%) and led to death in 2 patients (1%). There were other less severe complications (25 [14%]). No significant differences in outcome of stent placement procedures were found between both categories of centers. LIMITATIONS: Retrospective study involving many centers and the possibility of bias for different assessments of outcomes. CONCLUSIONS: In this study, success rates for SEMS placement and colonic decompression in MCRO were acceptable, without substantial differences according to the type of hospital. This procedure appeared to be feasible in general endoscopic practice.

Third-line rescue therapy with levofloxacin after two H. pylori treatment failures.

AIM: Eradication therapy with proton pump inhibitor, clarithromycin and amoxicillin fails in a considerable number of cases. A rescue therapy still fails in more than 20% of the cases. Our aim was to evaluate the efficacy and tolerability of a third-line levofloxacin-based regimen in patients with two consecutive Helicobacter pylori eradication failures. DESIGN: Prospective multicenter study. PATIENTS: In whom a first treatment with omeprazole-clarithromycin-amoxicillin and a second with omeprazole-bismuth-tetracycline-metronidazole (or ranitidine bismuth citrate with these antibiotics) had failed. INTERVENTION: A third eradication regimen with levofloxacin (500 mg b.i.d.), amoxicillin (1 g b.i.d.), and omeprazole (20 mg b.i.d.) was prescribed for 10 days. OUTCOME: Eradication was confirmed with 13C-urea breath test 4-8 wk after therapy. RESULTS: One-hundred patients were initially included, and nine were lost for follow-up. All patients but five took all the medications correctly. Per-protocol and intention-to-treat eradication rates were 66% (95% CI = 56-75%) and 60% (50-70%). Adverse effects were reported in 25% of the patients, mainly including metallic taste (8%), nausea (8%), myalgia/arthralgia (5%), and diarrhea (4%); none of them were severe. CONCLUSION: Levofloxacin-based rescue therapy constitutes an encouraging empirical third-line strategy after multiple previous H. pylori eradication failures with key antibiotics such as amoxicillin, clarithromycin, metronidazole, and tetracycline.

Comparison of two management strategies for Helicobacter pylori treatment: clinical study and cost-effectiveness analysis.

BACKGROUND: First-line proton pump inhibitor-based triple and quadruple therapies for Helicobacter pylori eradication present similar levels of efficacy. Cross-over treatment (quadruple following triple failure, and triple following quadruple failure) seems the most sensible approach to treatment failures, but the two strategies -'quadruple first' versus 'triple first'- have not been previously compared. The aims of our study were to assess the usefulness and the cost-effectiveness of the two treatment strategies. MATERIAL AND METHODS: Forty-nine out of 344 patients included in a previous study comparing triple therapy - 7 days of omeprazole, amoxicillin and clarithromycin twice a day - with quadruple therapy - 7 days of omeprazole twice a day, plus tetracycline, metronidazole and bismuth subcitrate three times a day - failed initial treatment and were assigned to cross-over therapy. Cure was determined by urea breath test. A decision analysis was performed to compare the two eradication strategies. RESULTS: Intention to treat cure rates were 46% (10/22 patients; 95% CI 24-68%) for second-line triple therapy and 63% (17/27 patients; 95% CI 42-81%) for second-line quadruple therapy. Per protocol cure rates were 71% and 85%, respectively. Intention to treat cure rates were 87% (95% CI 81-92%) for the 'triple first' versus 86% (95% CI 80-91%) for the 'quadruple first' strategy (p = .87). The 'quadruple first' strategy was more cost-effective. The incremental cost of 'triple first' strategy per person was 19 in the low-cost area and 65 US dollars in the high-cost area. CONCLUSIONS: The effectiveness of 'triple first' and 'quadruple first' strategies is similar, although the latter seems slightly more cost-effective.