F. Mocciaro

Fully covered self-expandable metallic stents in benign biliary strictures: a multicenter study on efficacy and safety

BACKGROUND AND STUDY AIM Benign biliary diseases include benign biliary stricture (BBS), lithiasis, and leaks. BBSs are usually treated with plastic stent placement; use of uncovered or partially covered metallic stents has been associated with failure related to mucosal hyperplasia. Some recently published series suggest the efficacy of fully covered self-expandable metal stents (FCSEMSs) in BBS treatment. We aimed to assess the efficacy and safety of FCSEMS in a large series of patients with BBS and a long follow-up.  PATIENTS AND METHODS Prospective multicenter clinical study at three tertiary referral centers: ISMETT/UPMC Italy, Palermo, San Paolo Hospital, Milan, and the ARNAS Civico Hospital, Palermo, Italy. All consecutive patients with BBS were treated with placement of FCSEMS rather than plastic stents, as first approach (11 patients, 17.7 %), or as a second approach after failure of other treatments (51 patients, 82.2 %). RESULTS From January 2008 to March 2011, 62 patients (40 male) were included. Mean period of FCSEMS indwelling was 96.7 days (standard deviation [SD] 6.5 days). In 15 patients (24.2 %) the SEMS migrated. Resolution of BBS occurred in 56 patients (90.3 %), while in 6 (9.6 %) the treatment failed. Mean (SD) follow-up after SEMS removal was 15.9 (10) months. FCSEMS placement as first- or second-line approach showed no difference in failure. Recurrence was observed in 4 /56 patients (7.1 %); all were transplant recipients: P = 0.01; odds ratio (OR) 1.2, confidence interval (CI) 1.1 - 1.3. CONCLUSIONS Despite the noteworthy migration rate, FCSEMSs should be considered effective for refractory benign biliary strictures. Further studies are needed to assess their role as a first approach in the management of BBS.

Fully covered metallic stents in biliary stenosis after orthotopic liver transplantation

BACKGROUND AND STUDY AIMS Data from a preliminary study suggested that the placement of a fully covered metal stent may be a valid alternative to surgery in patients who do not respond to standard endoscopic treatment. The aims of the current study were to evaluate the clinical success of self-expandable metallic stents (SEMS) in a large cohort of patients and with a long followup,and the effectiveness of SEMS placement as a first-line procedure. MATERIALS AND METHODS Between January 2008 and August 2010, 54 consecutive patients with biliary complications following orthotopic liver transplantation were treated with SEMS placement:39 after failure of conventional endoscopic therapy (Group I), and 15 with no previous endoscopic treatment who were undergoing SEMS placement as first-line treatment for complications(Group II). RESULTS In Group I, resolution after SEMS removal was observed in 71.8% of patients. Mean followup after resolution was 22.1 ±10 months. Recurrence of the complication was observed in 14.3%of patients after a mean of 8.5 months and SEMS migration was observed in 33.3% of patients. In Group II, resolution was observed in 53.3% of patients.Mean follow-up after resolution was 14.4±2.2 months. Recurrence was observed in 25% of patients and SEMS migration was observed in 46.7 %. CONCLUSIONS For endotherapy of biliary complications after orthotopic liver transplantation, metallic stents should not be used as the primary modality. In patients in whom the standard approach fails, treatment with temporary SEMS placement can solve biliary complications in almost three-quarters of cases; however stent migration(33 %) remains a problem.

Intraductal aspiration: a promising new tissue-sampling technique for the diagnosis of suspected malignant biliary strictures

BACKGROUND Brushing is the most commonly used technique for biliary sampling at ERCP, despite its limited sensitivity. OBJECTIVE To evaluate intraductal aspiration (IDA) as a new combined endoscopic technique for cytodiagnosis, its cellular adequacy, diagnostic accuracy for cancer detection, feasibility, and safety. DESIGN Prospective, observational study. SETTING Single tertiary referral center. MAIN OUTCOME MEASUREMENTS IDA cellular adequacy, diagnostic accuracy for cancer detection, feasibility, and safety. PATIENTS AND METHODS From April 2009 to September 2010, 42 consecutive patients with suspected malignant biliary stricture underwent ERCP, with tissue sampling obtained with IDA. IDA included performance of standard brushing in all patients. After standard brushing, to perform IDA, we removed the brush from its catheter and used the tip of the catheter as a scraping device. The tip was scraped back and forth across the stricture at least 10 times. The catheter and a suction line were connected to a specimen trap to obtain intraductal aspiration of fluids and samplings. RESULTS Our cytopathologists found adequate cellular yield in 39 of the 42 IDA samples (92.8%) versus 15 of the 42 brushing samples (35.7%) (P < .001). IDA showed a significantly higher sensitivity than brushing (89% vs 78% for adequate samples and 89% vs 37% for all samples) and provided significantly superior cellular adequacy (92.8% vs 35.7%). LIMITATIONS Observational study, small number of patients. CONCLUSIONS IDA significantly improves brushing cellular adequacy and has high sensitivity for cancer detection. It was also safe, simple, rapid, and applicable during routine diagnostic ERCP, with no additional costs.

Tulip bundle technique and fibrin glue injection: Unusual treatment of colonic perforation

We report a case of a 63-year-old male who experienced an iatrogenic sigmoid perforation repaired combining three endoscopic techniques. The lesion was large and irregular with three discrete perforations, therefore, we decided to close it by placing one clip per perforation, and then connecting all the clips with two endoloops. Finally we chose to use a fibrin glue injection to obtain a complete sealing. Four days after the colonoscopy the patient underwent a laparoscopic right hemicolectomy due to evidence of a large polyp of the caecum with high grade dysplasia and focal carcinoma in situ. Inspection of the sigma showed complete repair of the perforation. This report underlines how a conservative approach, together with a combination of various endoscopic techniques, can resolve complicated iatrogenic perforations of the colon.

Y-Shaped Bilateral Self-Expandable Metallic Stent Placement for Malignant Hilar Biliary Obstruction: Data from a Referral Center for Palliative Care

Background and Aim. Malignant hilar strictures are a clinical challenge because of the current therapeutic approach and the poor prognosis. In recent years, self-expandable metallic stents have proven more effective than plastic stents for palliation of malignant hilar strictures, with the bilateral stent-in-stent technique registering a high success rate. We report our experience with Y-shaped endoscopic self-expandable metallic stents placement for treatment of advanced malignant hilar strictures. Methods. From April 2009 to August 2012, we prospectively collected data on patients treated with Y-shaped SEMS placement for advanced malignant hilar carcinoma. Data on technical success, clinical success, and complications were collected. Results. Twenty patients (9 males) were treated (mean age 64.2 ± 15.3 years). The grade of malignant hilar strictures according to the Bismuth classification was II in 5 patients (25%), IIIa in 1 (5%), and IV in 14 (70%). The mean bilirubin level was 14.7 ± 4.9 mg/dL. Technical success was achieved in all patients, with a significant reduction in bilirubin levels (2.9 ± 1.7 mg/dL). One patient experienced cholangitis as early complication, while in 2 patients stent ingrowth was observed. No stents migration was recorded. There was no procedure-related mortality. At the end of the follow-up (7.1 ± 3.1 months), 13 of the 20 patients (65%) had died. Conclusions. Our experience confirms endoscopic bilateral self-expandable metallic stents placement with stent-in-stent technique (Y-shaped configuration) as a feasible, effective, and safe procedure for palliation of unresectable malignant hilar strictures.

DOP093 Characterisation of incident cases of cancer in inflammatory bowel disease: A prospective multicenter matched-pair IG-IBD study

DOP093 Characterisation of incident cases of cancer in inflammatory bowel disease: A prospective multicenter matched-pair IG-IBD study L. Biancone1 *, C. Petruzziello1, A. Armuzzi2, M.L. Scribano3, R. D’Inca4, C. Papi5, L. Spina6, L. Guidi2, A. Kohn3, E. Calabrese1, G. Condino1, S. Onali1, F. Mocciaro7, R. Monterubbianesi3, P. Alvisi8, W. Fries9, G. Riegler10, F. Castiglione11, I. Frankovic4, G. Margagnoni5, R. Di Mitri7, G. Meucci12, F. Rogai13, S. Ardizzone14, A. Orlando15, F. Pallone1. 1Universita di Roma Tor Vergata, Medicina dei sistemi, cattedra di Gastroenterologia, Roma, Italy, 2Universita Cattolica, CIC, Roma, Italy, 3A.O.San Camillo Forlanini, Gastroenterology Unit, Rome, Italy, 4University of Padova, Gastroenterology Department, Padova, Italy, 5AO S. Filippo Neri, UOC GE/Hep, Roma, Italy, 6Universita S. Donato, Gastroenterologia, Milano, Italy, 7ARNAS Civico-Di Cristina-Benfratelli Hospital, Gastroenterology and Endoscopy Unit, Palermo, Italy, 8Ospedale Maggiore, Pediatria, Bologna, Italy, 9Universita di Messina, Medicina Interna, Messina, Italy, 10Seconda Universita Napoli, SUN, Napoli, Italy, 11Universita “Federico II” di Napoli, Gastroenterologia, Napoli, Italy, 12S. Giuseppe Hospital, Gastroenterology, Milano, Italy, 13AOU Careggi, Largo Brambilla, Gastroenterologia, Firenze, Italy, 14Luigi Sacco University Hospital, Gastroenterology Department, Milano, Italy, 15Ospedale Cervello, Medicina Interna, Palermo, Italy

P.05.9 RISK ANALYSIS OF PNEUMONIA IN TWO DIFFERENT COHORTS OF PATIENTS WITH INFLAMMATORY BOWEL DISEASES

dipropionate in inducing remission and improving quality of life in patients with chronic refractory pouchitis. Material and methods: Ten consecutive patients with active pouchitis, not responding after 1 month of antibiotic treatment were treated with beclomethasone dipropionate 10 mg/day for 8 weeks. Symptomatic, endoscopic and histological evaluations were undertaken before and after treatment according to Pouchitis Disease Activity Index. Remission was defined as a combination of Pouchitis Disease Activity Index clinical score of =2, endoscopic score of =1 and total Pouchitis Disease Activity Index score of =4. Results: Eigth of 10 patients (80%) achieved remission. The median total Pouchitis Disease Activity Index scores before and after therapy were, respectively, 12 (range 8–14) and 3 (range 2–9) (P<0.001). Conclusions: Eight-week treatment with oral beclometasone dipropionate appears effective in inducing remission in patients with active pouchitis refractory to antibiotic treatment in this open-label study.

OC.04.2 DIAGNOSTIC ACCURACY OF RECTAL ENDOSCOPIC ULTRASONOGRAPHY TO DIAGNOSE DEEP PELVIC ENDOMETRIOSIS: EXPERIENCE FROM TWO REFERRAL GASTROENTEROLOGY UNITS

Background and aim: Intraoperatory radiofrequency ablation (RFA) of pancreas cancer has <8% complication rate.The ultrasound (EUS)-guided laser ablation might reduce risk because it is less invasive and able to discriminate the intervening vessels. Laser ablation (LA) performed with a neodymium:yttrium-aluminum garnet (Nd:YAG) laser can achieve a high rate of complete tissue necrosis and has been applied as a minimally invasive, palliative therapy in hepatic and thyroid lesions. In a previous study we assessed the feasibility of EUS Nd:YAG LA on normal pancreatic tissue performed in-vivo in a porcine model. Aims is to confirm the feasibility and to evaluate the safety and the efficacy of EUS Nd:YAG LA on normal pancreatic tissue of in-vivo porcine model. Material and methods: Six healthy farm swines, weighted 40-50 kg, underwent pancreas LA under EUS control during general anaesthesia. Pancreatic gland was punctured with a 19-gauge needle through transgastric approach. A 1.064-nm wavelenght Nd:YAG laser was used. Output power of 2 and 3 W with a total delivered energy of 1000 J was supplied in continuous mode, as used in our previous pilot study. Serum levels of amylase, lipase and transaminase were obtained at baseline, after three hours of the endoscopic treatment, and before the euthanizing of the animals. After the endoscopic treatment the animals were observed for clinical signs of pancreatitis (loss of appetite, altered consciousness and irritability). After 1 month the animals were sedated and then euthanized. The EUS-LA target organ was excised and placed in formalin. Histological examination of the specimens was performed by a single pathologist. Results: All pancreatic specimens showed histological signs of coagulative necrosis. The ablation volume ranged from a mean of 357 to 590 mm3. No histochemical signs of pancreatitis were found at pathologic examination. All the pigs survived at 1 month. During the follow-up no pigs showed clinical signs of pancreatitis and biochemical parameters were normal. No other complications were detected at necropsy. Conclusions: EUS-guided Nd:YAG LA of pancreas performed in vivo in a porcine model is feasible and safe. Nd:YAG laser creates a time-dependent ablation volume. Furthermore other studies are needed to apply this mini-invasive approach to human pancreatic lesions. OC.04.2

P.1.329: ENDOSCOPIC PLACEMENT OF SELF-EXPANDABLE METAL STENTS FOR MALIGNANT COLONIC OBSTRUCTION: A REGIONAL MULTICENTER EXPERIENCE IN A LARGE COHORT OF TREATED PATIENTS

Endoscopic Placement of Self-Expandable Metal Stents for Malignant Colonic Obstruction: A Regional Multicenter Experience in a Large Cohort of Treated Patients Roberto Di Mitri, Filippo Mocciaro, Mario Traina, Luigi M. Montalbano, Dario Raimondo, Clara Virgilio, Antonino Marino Gastroenterology Unit, A.R.N.A.S. “Civico Di Cristina Benfratelli” Hospital, Palermo, Italy; ISMETT, Palermo, Italy; Gastroenterology Unit, ”Villa Sofia-V. Cervello” Hospital, Palermo, Italy; Gastroenterology and Digestive Endoscopy Unit, San Raffaele-Giglio Hospital, Cefalu, Italy; Gastroenterology Unit, Garibaldi-Nesima Hospital, Catania, Italy Introduction: Self-expanding metal stents (SEMS) are a non-surgical option for treatment of malignant colorectal obstruction (CO) in symptomatic patients (pts), both as palliative treatment or bridging to surgery. With reported morbidity and mortality for emergency surgery as high as 39%, SEMS can be useful in resolving acute CO. Aims and methods: The aim of this study was to assess the efficacy and the safety of colonic SEMS placement, on elective or emergency bases, in a large cohort of symptomatic pts with malignant CO from 5 Sicilian tertiary centers. Between Jan. 2008 and Aug. 2010 the following patient data were collected: demographics, site and extension of neoplasia, indication (elective or emergency procedure), SEMS model, technical success, adverse events related to SEMS placement, quality of life (QoL), and survival. All pts signed informed consent before the procedure. Wallflex (Boston Scientific) and Evolution (Cook Medical) SEMS were placed under endoscopic guidance, with the aid of fluoroscopy, while Ultraflex Precision (Boston Scientific) SEMS were placed over the wire under fluoroscopy alone. All procedures were performed by experienced endoscopists, and took, on average, 30 minutes. Results: Ninety-five pts (54 male), with a mean age of 67.4 14.7, were evaluated. The CO was located in the rectosigma in 48 pts, the sigma in 19, descending colon in 10, transverse colon in 7, splenic flexure in 4, rectum in 4, ascending colon in 2, and hepatic flexure in 1. The mean length of the stenosis was 4.4 1.9 cm. Thirty-two pts (33.7%) were treated on an emergency basis, while 63 (66.3%) chose this treatment electively. Sixty-nine pts (72.7%) were treated palliatively, and 26 (27.3%) as bridge to surgery. Placed SEMS were: Wallflex in 77 pts, Evolution in 11, and Ultraflex Precision in 7. The mean follow-up was 9 7 months Technical success was achieved in 94/95 pts (98.9%), with colonic decompression and improvement of symptoms and QoL within 24 hours. Thirty-one of 32 pts (96.9%) treated on emergency basis achieved a significant clinical improvement. Seven pts required a second stent placement after a mean of 8.3 months because of ingrowth. Seven pts experienced an adverse event after SEMS placement: 2 perforations (2%) and 5 stent displacements (5%). Sixty-two pts died at the end of the follow up (68% of which treated palliatively and 32% as bridge to surgery). Conclusions: Our results, from a regional multicenter experience, confirm that SEMS, placed by experienced endoscopists, are safe and effective in inducing colonic decompression and symptomatic relief of malignant CO. In pts with severe acute obstruction, SEMS placement avoided the need for emergency surgery. SEMS can be a useful therapeutic approach in symptomatic pts before they undergo chemotherapy or surgical resection, and can improve outcomes and QoL.