Novel Hemostatic Gel As Rescue Therapy for Postsphincterotomy Bleeding Refractory to Self-Expanding Metallic Stent Placement.

Endoscopic sphincterotomy (ES) is commonly performed during endoscopic retrograde cholangiopancreatography, and bleeding is a severe adverse event. PuraStat is a peptide developed as a hemostatic agent for endoscopy. We report its use as a hemostatic strategy in post-ES bleeding refractory to combined hemostasis. A patient with choledocholithiasis underwent endoscopic retrograde cholangiopancreatography for stone removal. After the ES, severe bleeding refractory to the injection of diluted epinephrine around the bleeding source and metal stent placement occurred. Hemostasis was achieved with the application of the hemostatic gel. We reported the use of novel self-assembling hemostatic gel as an effective therapeutic tool for post-ES refractory bleeding.

Endoscopic Application of Purastat® in the Treatment of Solitary Rectal Ulcer Syndrome.

A 49-years-old woman with a recent history of tenesmus, constipation, abdominal and rectal pain referred to our Unit. There was no previous history of rectal bleeding or a family history of gastrointestinal diseases. Laboratory tests showed haemoglobin 10.9 g/dl, MCV 72fl, ferritin 18 U/l. Physical examination was normal. The patient underwent a colonoscopy which identified a single ulcer of 2.5 cm of diameter without bleeding signs in the distal rectum, 4 cm from the anal margin. Histopathological examination revealed shallow ulceration with fibrosis in lamina propria. We decided to treat the ulcer with one application of Purastat. Four weeks later, a follow-up colonoscopy revealed a complete mucosal healing with only mild residual mucosal erythema. Solitary Rectal Ulcer Syndrome (SRUS) is an uncommon benign proctologic disease usually affecting young adults with a prevalence of 1:100.000 per year, equally affecting women and men with a slight predominance in young women. SRUS is characterized by chronic rectal pain and bleeding, constipation, incomplete evacuation, tenesmus and mucous discharge impairing the patients' quality of life. In past years several topical agents have been used reporting clinical improvements, also if none of them has been evaluated in prospective controlled trials. Purastat (3D-Matrix Europe SAS, France) is a novel self-assembling peptide developed as a haemostatic agent for endoscopic and surgical procedures. In addition to the known haemostatic effect, it has been hypothesized that the activated Purastat nanostructure favors the cell and tissue proliferative process since the similarity of the activated Purastat 3-D nanostructure with the natural extracellular matrix (ECM-SM) scaffold material would result in an adequate adherence of cells and regenerative tissues, achieving more effective healing of the mucosa. Based on this hypothetical re-epithelizing property of Purastat, we decided to use it in this patient, achieving mucosal healing and symptoms improvement.

Fatal Outcome Consequent to an Endoscopic Full Thickness Resection of a Colonic Lateral Spreading Tumor: A Case Report.

BACKGROUND Endoscopic full-thickness resection represents an innovative procedure, used in selected patients that allows lesions en-bloc resection with an integral wall specimen available for histopathological definition. Bleeding and perforation are known to be the most frequent procedure-related adverse events. We report a case of entero-colonic fistula as complication of an endoscopic full-thickness resection. CASE REPORT A 77-year-old male, with a personal history of right-hemicolectomy for a colonic adenocarcinoma presented to our department for a routine colonoscopy that showed the presence of a 25 mm lateral spreading tumor localized at about 50 cm from the anal margin. A full-thickness resection of the lateral spreading tumor using the over-the-scope clip device was performed. After 4 weeks, because of abdominal pain, weight loss, diarrhea, and signs of malnutrition, the patient underwent a new colonoscopy showing hyperemic mucosa with ulcerations in all colonic segments and, at the site of the previous endoscopic full-thickness resection, an orifice of an entero-colonic fistula. The histological definition was suggestive for ulcerative proctocolitis and confirmed the presence of small bowel mucosa at fistula orifice. An intussusception at the level of fistula with consequent intestinal obstruction caused a worsening of clinical conditions and finally the patient death for a septic peritonitis. CONCLUSIONS Full thickness resection represents an innovative tool for en-bloc resection of gastrointestinal tumoral lesion, but procedural complications and limitations must be considered before performing this procedure.

Comparing intravenous and oral proton pump inhibitor therapy for bleeding peptic ulcers following endoscopic management: a systematic review and meta-analysis.

BACKGROUND AND AIMS: The efficacy of proton pump inhibitors (PPIs) has been demonstrated for bleeding peptic ulcers but the route of administration remains controversial. Several studies have demonstrated that high-dose oral PPIs are as effective as intravenous PPIs in reducing recurrent bleeding. However, current guidelines recommend intravenous PPIs after endoscopic treatment. Previous data based on numbers that were too small to enable a firm conclusion to be reached suggested that oral and intravenous PPIs had equivalent efficacy. We undertook a meta-analysis to compare oral and intravenous PPIs in patients with bleeding peptic ulcers after endoscopic management. METHODS: A literature search was undertaken using MEDLINE, EMBASE and the Cochrane Library, between 1990 and February 2016, to identify all randomized controlled trials (RCTs) that assessed the efficacy of PPIs administered by different routes. Nine RCTs, involving 1036 patients, were analysed. Outcomes were: recurrent bleeding, blood transfusion requirement, duration of hospital stay, a need for repeat endoscopy, surgery and 30-day mortality. RESULTS: There were no differences in the rebleeding rates [odds ratio (OR) 0.93, 95% confidence interval (CI) 0.60, 1.46; P = 0.77], need for surgery (OR 0.77, 95% CI 0.25, 2.40; P = 0.65), need for repeat endoscopy (OR 0.69, 95% CI 0.39, 1.21; P = 0.19), need for blood transfusion [(MD) -0.03, 95% CI -0.26, 0.19; P = 0.76], duration of hospital stay (MD -0.61, 95% CI -1.45, 0.23; P = 0.16) or 30-day mortality (OR 0.89, 95% CI 0.27, 2.43; P = 0.84) according to the route of administration. CONCLUSIONS: Oral PPIs represent better value for money, with clinical efficacy equivalent to intravenous PPIs.

Pre-operative Diagnosis of Pancreatic Neuroendocrine Tumors with Endoscopic Ultrasonography and Computed Tomography in a Large Series.

BACKGROUND AND AIMS: Diagnosis of pancreatic neuroendocrine tumors (p-NETs) is frequently challenging. We describe a large series of patients with p-NETs in whom both pre-operative Computed Tomography (CT) and Endoscopic Ultrasonography (EUS) were performed. METHODS: This was a retrospective analysis of prospectively collected sporadic p-NET cases. All patients underwent both standard multidetector CT study and EUS with fine-needle aspiration (FNA). The final histological diagnosis was achieved on a post-surgical specimen. Chromogranin A (CgA) levels were measured. RESULTS: A total of 80 patients (mean age: 58 +/- 14.2 years; males: 42) were enrolled. The diameter of functioning was significantly lower than that of non-functioning p-NETs (11.2 +/- 8.5 mm vs 19.8 +/- 12.2 mm; P = 0.0004). The CgA levels were more frequently elevated in non-functioning than functioning pNET patients (71.4% vs 46.9%; P = 0.049). Overall, the CT study detected the lesion in 51 (63.7%) cases, being negative in 26 (68.4%) patients with a tumor

Endoscopic multiple metal stenting for the treatment of enteral leaks near the biliary orifice: A novel effective rescue procedure.

Between April 2013 and October 2015, 6 patients developed periampullary duodenal or jejunal/biliary leaks after major abdominal surgery. In all patients, percutaneous drainage of the collection or re-operation with primary surgical repair was attempted at first but failed. A fully covered enteral metal stent was placed in all patients to seal the leak. Subsequently, we cannulated the common bile duct and, in some cases, and the main pancreatic duct inserting hydrophilic guidewires through the stent after dilating the stent mesh with a dilatation balloon or breaking the meshes with Argon Plasma Beam. Finally, we inserted a fully covered biliary metal stent to drain the bile into the lumen of the enteral stent. In cases of normal proximal upper gastrointestinal anatomy, a pancreatic plastic stent was also inserted. Oral food intake was initiated when the abdominal drain outflow stopped completely. Stent removal was scheduled four to eight weeks later after a CT scan to confirm the complete healing of the fistula and the absence of any perilesional residual fluid collection. The leak resolved in five patients. One patient died two days after the procedure due to severe, pre-existing, sepsis. The stents were removed endoscopically in four weeks in four patients. In one patient we experienced stent migration causing small bowel obstruction. In this case, the stents were removed surgically. Four patients are still alive today. They are still under follow-up and doing well. Bilio-enteral fully covered metal stenting with or without pancreatic stenting was feasible, safe and effective in treating postoperative enteral leaks near the biliopancreatic orifice in our small series. This minimally invasive procedure can be implemented in selected patients as a rescue procedure to repair these challenging leaks.

Endoscopic management of patients with post-surgical leaks involving the gastrointestinal tract: A large case series.

BACKGROUND: Post-surgical anastomotic leaks often require a re-intervention, are associated with a definite morbidity and mortality, and with relevant costs. We described a large series of patients with different post-surgical leaks involving the gastrointestinal tract managed with endoscopy as initial approach. METHODS: This was a retrospective analysis of prospectively collected cases with anastomotic leaks managed with different endoscopic approaches (with surgical or radiological drainage when needed) in two endoscopic centres during 5 years. Interventions included: (1) over-the-scope clip (OTSC) positioning; (2) placement of a covered self-expanding metal stent (SEMS); (3) fibrin glue injection (Tissucol); and (4) endo-sponge application, according to both the endoscopic feature and patient's status. RESULTS: A total of 76 patients underwent endoscopic treatment for a leak either in the upper (47 cases) or lower (29 cases) gastrointestinal tract, and the approach was successful in 39 (83%) and 22 (75.9%) patients, respectively, accounting for an overall 80.3% success rate. Leak closure was achieved in 84.9% and 78.3% of patients managed by using a single or a combination of endoscopic devices. Overall, leak closure failed in 15 (19.7%) patients, and the surgical approach was successful in all 14 patients who underwent re-intervention, whilst one patient died due to sepsis at 7 days. CONCLUSIONS: Our data suggest that an endoscopic approach, with surgical or radiological drainage when needed, is successful and safe in the majority of patients with anastomotic gastrointestinal leaks. Therefore, an endoscopic treatment could be attempted before resorting to more invasive, costly and risky re-intervention.

Empirical levofloxacin-containing versus clarithromycin-containing sequential therapy for Helicobacter pylori eradication: a randomised trial.

BACKGROUND AND AIMS: Antimicrobial drug resistance is a major cause of the failure of Helicobacter pylori eradication and is largely responsible for the decline in eradication rate. Quadruple therapy has been suggested as a first-line regimen in areas with clarithromycin resistance rate >15%. This randomised trial aimed at evaluating the efficacy of a levofloxacin-containing sequential regimen in the eradication of H pylori-infected patients in a geographical area with >15% prevalence of clarithromycin resistance versus a clarithromycin containing sequential therapy. METHODS: 375 patients who were infected with H pylori and naïve to treatment were randomly assigned to one of the following treatments: (1) 5 days omeprazole 20 mg twice daily + amoxicillin 1 g twice daily followed by 5 days omeprazole 20 mg twice daily +clarithromycin 500 mg twice daily + tinidazole 500 mg twice daily; or (2) omeprazole 20 mg twice daily +amoxicillin 1 g twice daily followed by omeprazole 20 mg twice daily + levofloxacin 250 mg twice daily +tinidazole 500 mg twice daily; or (3) omeprazole 20 mg twice daily + amoxicillin 1 g twice daily followed by omeprazole 20 mg twice daily + levofloxacin 500 mg twice daily + tinidazole 500 mg twice daily. Antimicrobial resistance was assessed by the E-test. Efficacy, adverse events and costs were determined for each group. RESULTS: Eradication rates in the intention-to-treat analyses were 80.8% (95% CI, 72.8% to 87.3%) with clarithromycin sequential therapy, 96.0% (95% CI, 90.9%to 98.7%) with levofloxacin-250 sequential therapy, and 96.8% (95% CI, 92.0% to 99.1%) with levofloxacin-500 sequential therapy. No differences in prevalence of antimicrobial resistance or incidence of adverse events were observed between groups. Levofloxacin-250 therapy was cost-saving compared with clarithromycin sequential therapy. CONCLUSION: In an area with >15% prevalence of clarithromycin resistant H pylori strains, a levofloxacin containing sequential therapy is more effective, equally safe and cost-saving compared to a clarithromycin containing sequential therapy.