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.

Complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones: randomized multicenter study.

Background and study aims Endoscopic sphincterotomy plus large-balloon dilation (ES-LBD) has been reported as an alternative to endoscopic sphincterotomy for the removal of bile duct stones. This multicenter study compared complete endoscopic sphincterotomy with vs. without large-balloon dilation for the removal of large bile duct stones. This is the first randomized multicenter study to evaluate these procedures in patients with exclusively large common bile duct (CBD) stones. Methods Between 2010 and 2015, 150 patients with one or more common bile duct stones ≥ 13 mm were randomized to two groups: 73 without balloon dilation (conventional group), 77 with balloon dilation (ES-LBD group). Mechanical lithotripsy was subsequently performed only if the stones were too large for removal through the papilla. Endoscopic sphincterotomy was complete in both groups. Patients could switch to ES-LBD if the conventional procedure failed. Results There was no between-group difference in number and size of stones. CBD stone clearance was achieved in 74.0 % of patients in the conventional group and 96.1 % of patients in the ES-LBD group (P < 0.001). Mechanical lithotripsy was needed significantly more often in the conventional group (35.6 % vs. 3.9 %; P < 0.001). There was no difference in terms of morbidity (9.3 % in the conventional group vs. 8.1 % in the ES-LBD group; P = 0.82). The cost and procedure time were not significantly different between the groups overall, but became significantly higher for patients in the conventional group who underwent mechanical lithotripsy. The conventional procedure failed in 19 patients, 15 of whom underwent a rescue ES-LBD procedure that successfully cleared all stones. Conclusions Complete endoscopic sphincterotomy with large-balloon dilation for the removal of large CBD stones has similar safety but superior efficiency to conventional treatment, and should be considered as the first-line step in the treatment of large bile duct stones and in rescue treatment.Trial registered at ClinicalTrials.gov (NCT02592811).

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).

Predictive factors of splanchnic vein thrombosis in acute pancreatitis: A 6-year single-center experience.

OBJECTIVE: Splanchnic vein thrombosis (SVT) is a potentially severe complication of pancreatitis. The aim of this single-center, retrospective cohort study was to investigate the incidence of SVT and to determine the connected risk factors. METHODS: All consecutive patients with acute pancreatitis (AP) managed in our hospital were included. The primary outcome was the occurrence of SVT and data was collected in accordance with Ranson's criteria. RESULTS: A total of 318 patients were included, of whom 124 (39.0%) were women. Biliary lithiasis was the main cause of pancreatitis (n = 156, 49.1%). A total of 19 (6.0%) SVT were identified. In univariate analysis, alcohol intake, smoking and male gender were associated with SVT (P = 0.005, 0.003 and 0.007, respectively). Biological parameters significantly associated with thrombosis were lactate dehydrogenase (LDH) < 500 U/L and hyperglycemia (≥ 10 mmol/L) (P = 0.009 and 0.016, respectively). In multivariate analysis, prothrombin time >75% was a protective factor against thrombosis (OR 0.148, P = 0.019). Leukocytes >10 × 10(9)/L (OR 6.397, P = 0.034), hyperglycemia (≥ 10 mmol/L) (OR 6.845, P = 0.023), LDH < 500 U/L ((OR 22.61, P = 0.001) and alcoholic etiology (OR 8.960, P = 0.041) were risk factors for SVT. CONCLUSIONS: Alcohol intake, male gender and smoking should focus the physician's attention on the risk of SVT. When further associated with certain biological parameters, the physicians should consider therapeutic anticoagulation to prevent SVT.

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.

Comparison and improvement of MELD and Child-Pugh score accuracies for the prediction of 6-month mortality in cirrhotic patients.

BACKGROUND/GOALS: Superiority of the model for end-stage liver disease (MELD) over the Child-Pugh score for the prediction of outcome in patients with chronic liver disease is still debated. The main objective of this prospective study was to evaluate the accuracy of the Child-Pugh score, the MELD, and the new score, MELD-Na, combining MELD and serum sodium (Na), for the prediction of 6-month mortality in cirrhotic patients. STUDY: In all, 308 consecutive cirrhotic patients were included. Child-Pugh score, MELD, and MELD-Na were calculated at the inclusion. RESULTS: In all, 154 patients (50.0%) had decompensated cirrhosis. Forty-five patients died during the 6-month follow-up: 3 in the subgroup of compensated cirrhosis and 42 in the decompensated subgroup (1.9% vs. 27.3%, P<10(-3)). Area under the receiver operating characteristic curve for the prediction of 6-month mortality of Child-Pugh score, MELD, and MELD-Na were, respectively, in the whole population: 0.882, 0.866, and 0.887 (P=NS), and in the subgroup of decompensated cirrhosis: 0.796, 0.800, and 0.833 (P=NS). MELD-Na had the highest accuracy but the difference reached statistical significance only with the Child-Pugh score in the subgroup of patients with decompensated cirrhosis (79.9% vs. 68.0%, P=0.006). The combination of Child-Pugh score or MELD with other variables reflecting the circulatory dysfunction observed in end-stage liver disease significantly improved the accuracy of these 2 models. CONCLUSIONS: Child-Pugh score remains a simple and effective tool for the prognostic assessment of cirrhotic patients at bedside and can still be used in clinical practice. MELD, and especially MELD-Na, should be reserved for patients with decompensated cirrhosis.