Endoscopic radiofrequency ablation or surveillance in patients with Barrett's oesophagus with confirmed low-grade dysplasia: a multicentre randomised trial.

OBJECTIVE: Due to an annual progression rate of Barrett's oesophagus (BO) with low-grade dysplasia (LGD) between 9% and 13% per year endoscopic ablation therapy is preferred to surveillance. Since this recommendation is based on only one randomised trial, we aimed at checking these results by another multicentre randomised trial with a similar design. DESIGN: A prospective randomised study was performed in 14 centres comparing radiofrequency ablation (RFA) (maximum of 4 sessions) to annual endoscopic surveillance, including patients with a confirmed diagnosis of BO with LGD. Primary outcome was the prevalence of LGD at 3 years. Secondary outcomes were the prevalence of LGD at 1 year, the complete eradication of intestinal metaplasia (CE-IM) at 3 years, the rate of neoplastic progression at 3 years and the treatment-related morbidity. RESULTS: 125 patients were initially included, of whom 82 with confirmed LGD (76 men, mean age 62.3 years) were finally randomised, 40 patients in the RFA and 42 in the surveillance group. At 3 years, CE-IM rates were 35% vs 0% in the RFA and surveillance groups, respectively (p<0.001). At the same time, the prevalence LGD was 34.3% (95% CI 18.6 to 50.0) in the RFA group vs 58.1% (95% CI 40.7 to 75.4) in the surveillance group (OR=0.38 (95% CI 0.14 to 1.02), p=0.05). Neoplastic progression was found in 12.5% (RFA) vs 26.2% (surveillance; p=0.15). The complication rate was maximal after the first RFA treatment (16.9%). CONCLUSION: RFA modestly reduced the prevalence of LGD as well as progression risk at 3 years. The risk-benefit balance of endoscopic ablation therapy should therefore be carefully weighted against surveillance in patients with BO with confirmed LGD. TRIAL REGISTRATION NUMBER: NCT01360541.

Narrow-band imaging versus Lugol chromoendoscopy for esophageal squamous cell cancer screening in normal endoscopic practice: randomized controlled trial.

BACKGROUND: Narrow-band imaging (NBI) is as sensitive as Lugol chromoendoscopy to detect esophageal squamous cell carcinoma (SCC) but its specificity, which appears higher than that of Lugol chromoendoscopy in expert centers, remains to be established in general practice. This study aimed to prove the superiority of NBI specificity over Lugol chromoendoscopy in the detection of esophageal SCC and high grade dysplasia (HGD) in current general practice (including tertiary care centers, local hospitals, and private clinics). METHODS: This prospective randomized multicenter trial included consecutive patients with previous or current SCC of the upper aerodigestive tract who were scheduled for gastroscopy. Patients were randomly allocated to either the Lugol or NBI group. In the Lugol group, examination with white light and Lugol chromoendoscopy were successively performed. In the NBI group, NBI examination was performed after white-light endoscopy. We compared the diagnostic characteristics of NBI and Lugol chromoendoscopy in a per-patient analysis. RESULTS: 334 patients with history of SCC were included and analyzed (intention-to-treat) from 15 French institutions between March 2011 and December 2015. In per-patient analysis, sensitivity, specificity, positive and negative likelihood values were 100 %, 66.0 %, 21.2 %, and 100 %, respectively, for Lugol chromoendoscopy vs. 100 %, 79.9 %, 37.5 %, and 100 %, respectively, for NBI. Specificity was greater with NBI than with Lugol (P = 0.002). CONCLUSIONS: As previously demonstrated in expert centers, NBI was more specific than Lugol in current gastroenterology practice for the detection of early SCC, but combined approaches with both NBI and Lugol could improve the detection of squamous neoplasia.

Efficacy of a three-day training course in endoscopic submucosal dissection using a live porcine model: a prospective evaluation.

BACKGROUND: Endoscopic submucosal dissection is currently regarded as the method of choice for the resection of superficial tumours. The objective of our study was to evaluate prospectively the efficiency of an endoscopic submucosal dissection training course using live anaesthetised pigs. METHODS: Fourteen novice endoscopists participated in three gastric endoscopic submucosal dissection training courses on anaesthetised pigs. Each trainee resected five 'fake' antral lesions. Resected specimen sizes, endoscopic submucosal dissection speeds and the complication rate were evaluated prospectively. RESULTS: Among the 70 procedures performed, 58 could be analysed. There was a strong increase in endoscopic submucosal dissection speed (from 9.7 mm2/minute to 30.4 mm2/minute) during the sessions, marked between the first two endoscopic submucosal dissections compared with the fourth and fifth. There was a significant relation between the surface area of the resected lesion and procedure speed (P < 0.0001). The complication rate was 8.6%. CONCLUSION: There is a clear benefit from endoscopic submucosal dissection training courses on animal models. Improved endoscopist capability is evident from the third endoscopic submucosal dissection. These data validate the indispensable nature of dedicated training courses and echo the European Society of Gastrointestinal Endoscopy proposition for multistep learning, beginning on animal models.

A novel hemostatic powder for upper gastrointestinal bleeding: a multicenter study (the "GRAPHE" registry).

Background and study aims: The hemostatic powder TC-325 (Hemospray; Cook Medical, Winston-Salem, North Carolina, USA) has shown promising results in the treatment of upper gastrointestinal bleeding (UGIB) in expert centers in pilot studies. The aim of this study was to evaluate the feasibility and efficacy of TC-325 in a large prospective registry of use in routine practice. Patients and methods: The data of all patients treated with TC-325 were prospectively collected through a national registry. Outcomes were the immediate feasibility and efficacy of TC-325 application, as well as the rates of rebleeding at Day 8 and Day 30. Multivariate analysis was performed to determine predictive factors of rebleeding. Results: A total of 202 patients were enrolled and 64 endoscopists participated from 20 centers. TC-325 was used as salvage therapy in 108 patients (53.5 %). The etiology of bleeding was an ulcer in 75 patients (37.1 %), tumor in 61 (30.2 %), postendoscopic therapy in 35 (17.3 %), or other in 31 (15.3 %). Application of the hemostatic powder was found to be very easy or easy in 31.7 % and 55.4 %, respectively. The immediate efficacy rate was 96.5 %. Recurrence of UGIB was noted at Day 8 and Day 30 in 26.7 % and 33.5 %, respectively. Predictive factors of recurrence at Day 8 were melena at initial presentation and use of TC-325 as salvage therapy. Conclusion: These multicenter data confirmed the high rate of immediate hemostasis, excellent feasibility, and good safety profile of TC-325, which could become the treatment of choice in bleeding tumors or postendoscopic bleeding but not in bleeding ulcers where randomized studies are needed. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02595853).

Management of acute malignant large-bowel obstruction with self-expanding metal stent.

PURPOSE: Colorectal stents are being used for palliation and as a "bridge to surgery" in obstructing colorectal carcinoma. The purpose of this study was to review our experience with self-expanding metal stents (SEMS) as the initial interventional approach in the management of acute malignant large-bowel obstruction. METHODS: Between February 2002 and August 2009, 93 patients underwent the insertion of a SEMS for an obstructing malignant lesion of the left-sided colon or rectum. RESULTS: In 66 patients, the stents were placed for palliation; whereas, in 27 patients they were placed as a bridge to surgery. Stent placement was technically successful in 92.5% (n = 86) of the patients, with a clinical success rate of 86% (n = 80). Three perforations occurred during stent placement, two were treated by an emergency Hartmann operation, and one by a colostomy. In the intention to treat by stent, the peri-interventional mortality was 6.5% (6/93). Stent migration was reported in three cases (3%), and stent obstruction occurred in 11 cases (12%). Of the 24 patients with stents successfully placed as a bridge to surgery, 22 underwent elective single-stage operations with no death or anastomotic complication. CONCLUSION: Stent insertion provided an effective outcome in patients with malignant colonic obstruction as a palliative and preoperative therapy.