Placement of a new fully covered self-expanding metal stent for postoperative biliary strictures and leaks not responding to plastic stenting.

Fully covered self-expanding metal stents (FCSEMSs) are now being used to treat postoperative biliary strictures (BSs) and biliary leaks (BLs). The aim of this study was to assess the safety and effectiveness of a new FCSEMS (Wallflex) in patients with postoperative BSs and BLs after failure of traditional endoscopic treatment. Between January 2010 and December 2011, 16 patients (10 patients with postcholecystectomy BSs, 4 with postcholecystectomy BLs, and 2 with postorthotopic liver transplantation BSs) were enrolled. The technical and clinical success rate was 100%. All FCSEMSs were removed after a mean of 141 days. Complications occurred in 7 cases: 2 postprocedure pain, 2 mild pancreatitis, 1 early distal, and 2 late proximal FCSEMS migration. The overall long-term clinical success rate was 94% after a mean follow-up of 13 months. In our experience, the placement of FCSEMSs is an effective and secure method of treating refractory postoperative BSs or BLs.

Covered removable self-expandable metal [corrected] stents for the treatment of refractory benign biliary disease.

OBJECTIVE: The aim of the study was to verify the use of covered removable self-expandable metal stents (CRSEMS) in benign biliary disease after a failure of traditional endoscopic treatment. METHODS: A total of 23 patients who failed traditional endoscopic therapy were enrolled in the study and treated with CRSEMS. RESULTS: Among all the patients, 11 had a bile leak and 12 suffered benign biliary stenosis. Technical success and immediate clinical success were achieved in all the patients. The overall long-term clinical success rate after stent removal was 100%. The CRSEMS were left in place for a median of 47 days (range 30-240 days). Immediate complications occurred in one patient, stent migration in two and overgrowth of inflammatory tissue in the stent in two. CONCLUSION: CRSEMS is an excellent treatment option for patients with benign biliary disease.

Colorectal stenting as a bridge to surgery reduces morbidity and mortality in left-sided malignant obstruction: a predictive risk score-based comparative study.

BACKGROUND: The Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity model, and its Portsmouth and colorectal modifications are used to predict postoperative mortality and morbidity after colorectal surgery. AIMS: To compare stent placement as a bridge to surgery vs. emergency surgical resection in patients with acute left-sided colorectal cancer obstruction using P-POSSUM and CR-POSSUM. METHODS: From January 2008 to December 2009, the physiological and operative scores, morbidity and mortality predicted by the P-POSSUM and CR-POSSUM scores were collected in all consecutive patients with LCCO who underwent surgical resection directly (Group A) or after stent placement (Group B). RESULTS: Eighty-six patients were enrolled (Group A-41 and Group B-45). The observed 30-day mortality rate was 9.8% (4/41) in Group A and 2.4% (1/45) in Group B. The 30-day morbidity rate was 61% (25/41) in Group A and 29% (13/45) in Group B. The mean values of P-POSSUM morbidity (A=70.5% vs. B=34.3%; p=0.001), P-POSSUM mortality (A=13.6% vs. B=2.4%; p=0.001) and CR-POSSUM mortality (A=15.1% vs. B=4.9%; p=0.001) were significantly lower in the Group B patients than in the Group A patients. CONCLUSIONS: Bridge to surgery strategy reduces the surgical risks in LCCO, and P-POSSUM and CR-POSSUM scores represent a good tool for comparing the two strategies.

A comparison of uncovered metal stents for the palliation of patients with malignant biliary obstruction: nitinol vs. stainless steel.

BACKGROUND: Various types of self-expandable metal stents have been introduced for the palliation of malignant biliary obstruction. AIMS: To compare the outcomes of WallFlex™ and Wallstent™ uncovered biliary self-expandable metal stents (SEMSs) for the palliation of patients with malignant biliary obstruction. METHODS: Between October 2008 and December 2009, all SEMSs placed for malignant biliary obstruction were WallFlex™: all patients palliated were included in the study. Before October 2008, all the SEMSs placed for malignant biliary obstruction were Wallstent™, and the patients palliated from July 2007 to September 2008 were the comparative group. RESULTS: A total of 58 WallFlex™ and 54 Wallstent™ SEMSs were placed, and efficacious biliary decompression was achieved in all patients. Early complications occurred in 5 patients in the WallFlex™ group and in 3 in the Wallstent™ group (p=ns). Late complications occurred in 6 patients in the WallFlex™ group and in 16 in the Wallstent™ group (p<0.01). The overall patency of the self-expandable metal stent in the WallFlex™ and the Wallstent™ groups was similar (227 days vs. 215 days, p=ns). Mean patient survival was 242 days in the WallFlex™ group and 257 days in the Wallstent™ group (p=ns). CONCLUSIONS: We found no difference in terms of overall patency between the two types of SEMSs, but there was an increased rate of late adverse events in the Wallstent™ group.

Endoscopic ultrasound-guided fine needle aspiration with 22- and 25-gauge needles in solid pancreatic masses: a prospective comparative study with randomisation of needle sequence.

BACKGROUND: The difference in the diagnostic accuracy of 22- versus 25-gauge needles in EUS-FNA is not clear. AIMS: To compare the rates of technical success, diagnostic accuracy and complications of EUS-FNA performed with 22-gauge and 25-gauge needles on the same solid pancreatic mass. METHODS: All patients with solid pancreatic masses evaluated from September 2007 to December 2008 were enrolled and underwent EUS-FNA with both 22- and 25-gauge needles with randomisation of needle sequence. The accuracy of the EUS-FNA was determined by comparing the cytological results with the final surgical pathological diagnoses or with the results of a clinical follow-up. A cytological score with different qualitative parameters was created, and a comparison between these parameters was carried out for each needle. RESULTS: Fifty patients with 50 pancreatic masses were recruited. Technical success was 100% and no complications occurred. Diagnostic accuracy was 94% and 86% for the 25- and 22-gauge needles, respectively. Analysis of the cytological score showed a tendency towards the 25-gauge needle, although the difference was not statistically significant. CONCLUSIONS: EUS-FNA performed with 22- or 25-gauge needles had the same diagnostic accuracy. Our study results confirm a significant trend towards a better cytological diagnosis for the 25-gauge needle.

Through-the-scope large diameter self-expanding metal stent placement as a safe and effective technique for palliation of malignant colorectal obstruction: a single center experience with a long-term follow-up.

OBJECTIVE: The aim of this study was to evaluate the outcomes of through-the-scope (TTS) large diameter self-expanding metal stent (SEMS) placement for palliation of malignant colorectal obstruction. MATERIAL AND METHODS: Between January 2005 and December 2009, all patients who underwent endoscopic SEMS placement for palliation of malignant colorectal obstruction were prospectively enrolled. RESULTS: Thirty-nine patients (17M and 22F; mean age 75.9 ± 10.6 years, range 50-91) were enrolled. The most frequent location was the sigmoid colon (13 cases). The causes of obstruction were colorectal malignancy in 32 patients and extracolonic malignancy in 7. Technical success was achieved in 36/39 patients (92.3%) and clinical success in 35/39 patients (89.7%). Technical failure was related to female sex (p = 0.04) and the extracolonic etiology of the stricture (p < 0.001). There were three early complications: two procedure-related perforations successfully managed conservatively and one hemorrhage treated with APC. Early complications were related to the location of strictures at the recto-sigmoid junction (p < 0.001). Late complications occurred in 10 patients: 8 of these patients experienced occlusive symptoms (attributable to tumor ingrowth in 5 cases and stool impaction in 3 cases); the remaining 2 were one case of tumor ingrowth with sub-occlusive symptoms and hemorrhage, and one case of distal migration. There was no procedure-related mortality and all complications were managed without surgical intervention. SEMS patency duration was 236 ± 128 days (range 31-497) and mean survival of the patients was 259 ± 121 days (range, 32-511). CONCLUSIONS: In our experience, TTS large-diameter SEMS placement is a safe and effective treatment for palliation of malignant colorectal obstruction.

Interobserver agreement in describing video capsule endoscopy findings: a multicentre prospective study.

BACKGROUND AND AIM: Few studies have specifically addressed interobserver agreement in describing lesions identified during capsule endoscopy. The aim of our study is to evaluate interobserver agreement in the description of capsule endoscopy findings. MATERIALS AND METHODS: Consecutive short segments of capsule endoscopy were prospectively observed by 8 investigators. Seventy-five videos were prepared by an external investigator (gold standard). The description of the findings was reported by the investigators using the same validated and standardized capsule endoscopy structured terminology. The agreement was assessed using Cohen's kappa statistic. RESULTS: As concerns the ability to detect a lesion, the agreement with the gold standard was moderate (kappa 0.48), as well as the agreement relating to the final diagnosis (κ 0.45). The best agreement was observed in identifying the presence of active bleeding (κ 0.72), whereas the poorest agreement concerned the lesion size (κ 0.32). The agreement with the GS was significantly better in endoscopists with higher case/volume of capsule endoscopy per year. Diagnostic concordance was better in the presence of angiectasia than in the presence of polyps or ulcers/erosions. CONCLUSIONS: Correct lesion identification and diagnosis seem more likely to occur in presence of angiectasia, and for readers with more experience in capsule endoscopy reading.

Efficacy, safety and outcomes of 'inject and cut' endoscopic mucosal resection for large sessile and flat colorectal polyps.

BACKGROUND AND STUDY AIMS: The study examines the outcomes of the 'inject and cut' endoscopic mucosal resection (EMR), for large sessile and flat colorectal polyps. PATIENTS AND METHODS: Between January 2006 and December 2008 all patients referred to our institution for EMR of large polyps were prospectively evaluated. The accuracy of lifting sign and the rate of en bloc and piecemeal resection, complications and recurrence were analyzed. RESULTS: A total of 157 patients with 182 lesions (median size 24.7 +/- 10.2 mm) were included in the study. The most frequent location was the sigmoid colon in 30.2%. Because of non-lifting sign, 5/182 lesions were referred to surgical resection and 177 (43 flat and 134 sessile) were resected, 79 (44.6%) en bloc and 98 (55.4%) piecemeal. There were 20 procedural (11.3%) and 2 late (1.1%) bleeding, 4 post-polypectomy syndrome (2.2%) and 2 perforations (1.1%). Bleeding was related to malignancy (p = 0.01). Intramucosal cancer was observed in 5 cases (2.8%) while invasive cancer was seen in 8 (4.5%). Malignancy was related to polyp size >or=30 mm (p = 0.002). Follow-up colonoscopy was performed in 147 patients with 172 EMR for a mean of 19.8 months. Recurrence was observed in 12/172 (6.9%) polyps. CONCLUSION: Inject and cut EMR is practical and effective with a low risk of complication and local recurrence.

Endoclip-assisted resection of large pedunculated colorectal polyps: technical aspects and outcome.

BACKGROUND: The most common complication of polypectomy is hemorrhage, and various techniques have been used to prevent this complication. AIM: This study evaluates the outcomes of endoclip-assisted polypectomy in patients with large pedunculated colorectal polyps, in comparison with a historical control group of patients treated with endoloop-assisted polypectomy. METHODS: Between January and December 2007, 32 patients with 32 large pedunculated polyps (>or=15 mm) were treated with endoclip-assisted polypectomy (group A). Between January and December 2006, 35 patients with 35 large pedunculated polyps were treated; 33 with endoloop-assisted polypectomy (control, group B) and two cases with endoclips and needle knife, which were included in group A for the analysis. RESULTS: The mean (+/- standard deviation [SD]) size of polyp head was 26.8 +/- 8.1 mm (range 15-50) in group A and 22.3 +/- 4.1 mm (range 15-30) in group B (P = 0.004). In group A, six polyps had a mean (+/-SD) head size of 40.8 +/- 5.8 mm (range 35-50) and were resected with clips and needle knife. In group A, bleeding occurred in two cases (5.9%), which were associated with the presence of cancer at histology (P = 0.006) and were managed by applying new clips. No bleeding occurred in patients of group B and no perforation and post-polypectomy syndrome occurred in either group. There were three (8.8%) cancerized adenomas in group A and one (3%) in group B. Clip application was possible in all patients, while in two cases, loop placement was impossible. CONCLUSIONS: In our experience, endoclip-assisted resection is a safe alternative to endoloop for the resection of large pedunculated colorectal polyps when endoloop placement is difficult or impossible.

Single session versus separate session endoscopic ultrasonography plus endoscopic retrograde cholangiography in patients with low to moderate risk for choledocholithiasis.

BACKGROUND AND AIM: Endoscopic ultrasonography (EUS) is a minimally invasive diagnostic tool for common bile duct stones (CBDS) and may be used to select patients for therapeutic endoscopic retrograde cholangiography (ERC). The aim of this trial is to compare, in patients with non-high-risk for CDBS, the clinical and economic impact of EUS plus ERC performed in a single endoscopic session versus EUS plus ERC in two separate sessions. METHODS: During an 11-month period, all adult patients admitted to the emergency department with suspicion of CBDS were categorized into either high-risk or non-high-risk groups, on the basis of clinical, biochemical, or transabdominal ultrasound findings. Patients in the non-high-risk group were randomized to receive EUS plus ERC in one single or in two separate sessions. RESULTS: Eighty patients were recruited and randomized. Forty patients underwent EUS plus ERC in a single session and 40 patients underwent EUS plus ERC in two separate sessions. Negative EUS examination for CBDS avoided unnecessary ERC to 33 patients. Out of 47 patients with positive EUS (25 from the single session group and 22 from the double session), ERC confirmed the presence of CBDS in 46 cases (EUS sensitivity 100% and specificity 98%). Average time of procedure and hospitalization were significantly shorter in the single session group compared to the two session group. The single session strategy was also less expensive. CONCLUSION: Endoscopic ultrasonography plus ERC with sphincterotomy and stone extraction performed during the same endoscopic session was safe and efficacious with a reduction of procedure time, hospitalization and costs.

Timing of precut procedure does not influence success rate and complications of ERCP procedure: a prospective randomized comparative study.

BACKGROUND: There is scarce information on whether performing the precut procedure early rather than after several cannulation attempts is associated with different success and complication rates. OBJECTIVE: To compare the success and complication rates of precutting implemented either early or after prolonged attempts by the standard approach. DESIGN: Single-center prospective randomized study. SETTING: Tertiary care center. PATIENTS: Over the 2-year study period, 1078 therapeutic ERCP procedures were performed. One hundred forty-six patients (mean age 68.5 years [range: 34-88 years], 67 men and 79 women) met the selection criteria and were randomized into 2 groups (on a 1:3 basis): group A underwent precut immediately after randomization (36 patients) and group B underwent standard cannulation attempts for a further 20 minutes followed by needle-knife precut in case of failure (110 patients). MAIN OUTCOME MEASUREMENTS: Deep biliary cannulation and the incidence of post-ERCP complications. RESULTS: The precut procedure performed in group A allowed deep cannulation of the common bile duct in 33 of 36 patients (92%). In group B, cannulation was successfully achieved in 104 of 110 patients (95%). Among group B patients, biliary cannulation was achieved with the standard approach in 78 patients, whereas precutting was performed in 32 patients, and deep cannulation was achieved in 26 of them. The overall complication rate was 8% (3/36) in group A and 6% (7/110) in group B. LIMITATIONS: Small sample size. CONCLUSIONS: Timing of pre-cutting does not appear to influence success and complication rates of ERCP procedures.

WallFlex colonic stent placement for management of malignant colonic obstruction: a prospective study at two centers.

BACKGROUND: Self-expanding metal stents (SEMSs) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery. The use of colonic larger-diameter SEMSs may improve bowel function and reduce migration risk. OBJECTIVE: To evaluate the effectiveness and safety of a novel large-diameter SEMS (WallFlex) designed for delivery through the endoscope in treating malignant colonic obstruction. DESIGN: Prospective clinical cohort study. SETTING: Two Italian study centers. PATIENTS: Forty-two consecutive patients with malignant colonic obstruction: 23 requiring palliation and 19 bridging to surgery. INTERVENTIONS: Colorectal SEMS placement. MAIN OUTCOME MEASUREMENTS: Technical success, defined as accurate SEMS deployment across the stricture on the first attempt; clinical success, ie, complete relief of bowel obstruction without complications; and bridging to surgery, denoting the performance of elective one-stage surgery. RESULTS: The rate of technical success was 93% (95% CI, 81%-99%) and of initial clinical success was 95% (95% CI, 84%-99%). In 58% (95% CI, 40%-84%) of the palliation group, clinical success was maintained after 6 months. All 19 patients with operable tumors were successfully bridged to one-stage elective surgery within a median of 5 days. One perforation and one stent migration occurred. All complications could be resolved nonsurgically. LIMITATIONS: No control group was included. CONCLUSIONS: In a prospective study of through-the-scope WallFlex stent placement for malignant colonic obstruction, high rates of technical and initial clinical success, and bridging to surgery were achieved. Complications could be readily managed.

Anesthesiological risk and endoscopic sphincterotomy in acute biliary pancreatitis.

INTRODUCTION: The rate of complications after endoscopic sphincterotomy (ES) is about 10%, and early complications have been reported in 20% of patients considered unfit for surgery. AIM: To evaluate the early and long-term results of endoscopic intervention in relation to the anesthesiological risk for 87 patients with acute biliary pancreatitis. METHODOLOGY: All patients underwent endoscopic retrograde cholangiopancreatography (ERCP) and were evaluated according to the American Society of Anesthesiology (ASA) criteria immediately before the operative procedure. Patients' ASA scores were as follows: 49.4%, ASA 2; 29.9%, ASA 3; and 20.7%, ASA 4. RESULTS: The severity of acute pancreatitis was positively related to the anesthesiological grade (p = 0.014). Six patients (6.9%) had complications related to the endoscopic procedure. There was no significant relationship between the frequency of biliopancreatic complications during the follow-up (23/84, 27.4%) and the ASA grade. The frequency of cholecystectomy was inversely related to the ASA grade (p = 0.003). Seven patients (8.3%) died during the follow-up period: multivariate analysis showed that the ASA grade (odds ratio [OR], 10.9; 95% confidence interval [CI], 1.2-96.6; p = 0.001) and age (OR, 1.1; 95% CI, 1.0-1.3; p = 0.037) were significantly related to survival. CONCLUSIONS: Endoscopic treatment is safe and effective in patients at high anesthesiological risk with acute pancreatitis, and survival is significantly related to the ASA grade.