Safety and efficacy of metallic stent for unresectable distal malignant biliary obstruction in elderly patients.

AIM: To study the safety of insertion of metallic stents in elderly patients with unresectable distal malignant biliary obstruction. METHODS: Of 272 patients with unresectable distal malignant biliary obstruction, 184 patients under the age of 80 were classified into Group A, and 88 subjects aged 80 years or more were classified into Group B. The safety of metallic stent insertion, metal stent patency period, and the obstruction rate were examined in each group. RESULTS: In Group B, patients had a significantly worse performance status, high blood pressure, heart disease, cerebrovascular disease, and dementia; besides the rate of patients orally administered antiplatelet drugs or anticoagulants tended to be higher (P < 0.05). Metallic stents were successfully inserted in all patients. The median patency period was 265.000 ± 26.779 (1-965) d; 252.000 ± 35.998 (1-618) d in Group A and 269.000 ± 47.885 (1-965) d in Group B, with no significant difference between the two groups. Metallic stent obstruction occurred in 82 of the 272 (30.15%) patients; in 53/184 (28.80%) patients in Group A and in 29/88 (32.95%) of those in Group B, showing no significant difference between the two groups. Procedural accidents due to metal stent insertion occurred in 24/272 (8.8%) patients; in 17/184 (9.2%) of patients in Group A and in 7/88 (8.0%) of those in Group B, with no significant difference between the two groups, either. CONCLUSION: These results suggested that metallic stents can be safely inserted to treat unresectable distal malignant biliary obstruction even in elderly patients aged 80 years or more.

Performance of novel tissue harmonic echo imaging using endoscopic ultrasound for pancreatic diseases.

BACKGROUND AND STUDY AIMS: Recently, tissue harmonic echo (THE) imaging has advanced with the development of a new endoscopic ultrasound (EUS) monitor/processing unit. With this new technology, penetration (THE-P) and resolution (THE-R) images can be obtained. The aim of this study was to investigate the performance of this novel THE imaging using a new processing unit for pancreatic diseases. PATIENTS AND METHODS: Fifty patients with pancreatic lesions (38 cystic, 12 solid) were retrospectively analyzed. At each examination, 3 EUS images of the same pancreatic lesion were obtained using B-mode, THE-P mode, and THE-R mode imaging. Each set of EUS images was randomly arranged and evaluated independently by 4 physicians blinded to the imaging technique. Images were compared using a Likert scale 5-point grading system for each parameter. RESULTS: For cystic lesions, THE-P mode images were significantly superior to conventional B-mode images for visualizing the boundary, septum, nodules, and total image quality (P < 0.05). THE-R mode images were significantly superior to conventional B-mode images for visualizing the boundary, septum, and total image quality (P < 0.05). However, for solid lesions, there was no significant difference in all the evaluation points between THE-P and conventional B-mode images. THE-R mode images were inferior to conventional B-mode images for visualizing the boundary, internal structure, and total image quality (P < 0.05). CONCLUSIONS: For pancreatic cystic lesions, THE mode images provided better lesion characterization than conventional B-mode images. Further research is required to determine if this improvement will result in improved EUS diagnostics.

Is endoscopic papillary large balloon dilatation without endoscopic sphincterotomy effective?

AIM: To evaluate the safety and efficacy of endoscopic papillary large balloon dilatation (EPLBD) without endoscopic sphincterotomy in a prospective study. METHODS: From July 2011 to August 2013, we performed EPLBD on 41 patients with naïve papillae prospectively. For sphincteroplasty of EPLBD, endoscopic sphincterotomy (EST) was not performed, and balloon diameter selection was based on the distal common bile duct diameter. The balloon was inflated to the desired pressure. If the balloon waist did not disappear, and the desired pressure was satisfied, we judged the dilatation as complete. We used a retrieval balloon catheter or mechanical lithotripter (ML) to remove stones and assessed the rates of complete stone removal, number of sessions, use of ML and adverse events. Furthermore, we compared the presence or absence of balloon waist disappearance with clinical characteristics and endoscopic outcome. RESULTS: The mean diameters of the distal and maximum common bile duct were 13.5 ± 2.4 mm and 16.4 ± 3.1 mm, respectively. The mean maximum transverse-diameter of the stones was 13.4 ± 3.4 mm, and the mean number of stones was 3.0 ± 2.4. Complete stone removal was achieved in 97.5% (40/41) of cases, and ML was used in 12.2% (5/41) of cases. The mean number of sessions required was 1.2 ± 0.62. Pancreatitis developed in two patients and perforation in one. The rate of balloon waist disappearance was 73.1% (30/41). No significant differences were noted in procedure time, rate of complete stone removal (100% vs 100%), number of sessions (1.1 vs 1.3, P = 0.22), application of ML (13% vs 9%, P = 0.71), or occurrence of pancreatitis (3.3% vs 9.1%, P = 0.45) between cases with and without balloon waist disappearance. CONCLUSION: EST before sphincteroplasty may be unnecessary in EPLBD. Further investigations are needed to verify the relationship between the presence or absence of balloon waist disappearance.

Diagnostic ability of EUS-FNA for pancreatic solid lesions with conventional 22-gauge needle using the slow pull technique: a prospective study.

OBJECTIVE: Endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) using the slow pull technique (SP-FNA) has recently attracted attention as an effective tissue acquisition technique. However, efficacy of SP-FNA with a 22-gauge conventional needle remains unclear. The aim of this study is to evaluate the diagnostic ability of SP-FNA with a 22-gauge needle. MATERIAL AND METHODS: Patients with a pancreatic solid lesion were prospectively enrolled in this study. SP-FNA was performed at two needle passes with a 22-gauge needle. One dedicated pathologist evaluated the obtained samples in terms of quantity (Grade 0: scant; Grade 1: inadequate; Grade 2: adequate), quality (Grade 0: poor; Grade 1: moderate; Grade 2: good), and blood contamination (Grade 0: significant; Grade 1: moderate; Grade 2: low), and provided a pathological diagnosis. Additional EUS-FNA was performed by applying suction (SA-FNA). The evaluation points were as follows: diagnostic accuracy of SP-FNA compared with that of SA-FNA, and the quantity, quality, and blood contamination level of SP-FNA-obtained samples. RESULTS: We enrolled 40 cases. The diagnostic accuracy of SP-FNA was 90% (36/40). There was no significant difference in the accuracy between SP-FNA and SA-FNA (90% vs. 90%, p = 1.000). The samples obtained using SP-FNA were assessed as Grade 2 for quantity in 29 cases (73%), quality in 31 (78%), and blood contamination in 25 (63%). CONCLUSIONS: Adequate, high-quality, and unsubstantially blood-contaminated samples could be obtained using SP-FNA. The diagnostic ability of SP-FNA was 90%, which appeared to be similar to that of SA-FNA.

Feasibility, efficacy, and predictive factors for the technical success of endoscopic nasogallbladder drainage: a prospective study.

BACKGROUND/AIMS: Several studies have shown the useful-ness of endoscopic nasogallbladder drainage (ENGBD) in patients with acute cholecystitis. However, the procedure is difficult, and factors that affect technical success have not yet been clarified. We conducted a prospective study to eval-uate the technical feasibility, efficacy, and predictive factors for the technical success of ENGBD in patients with acute cholecystitis. METHODS: All patients with moderate or severe acute cholecystitis who were enrolled underwent ENGBD between April 2009 and April 2011. Patients with surgically altered anatomy or pancreatobiliary malignancies were ex-cluded. The primary outcomes included technical success, clinical success, and complications. Factors that could affect the technical success were also examined. RESULTS: Of the 27 patients who underwent ENGBD during the study period, technical success was achieved in 21 (78%) and clinical improvement was achieved in 20 (95%). Early complications were encountered in four patients (15%). Gallbladder wall thickness (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.08 to 2.47) and age (OR, 1.16; 95% CI, 1.00 to 1.35) were effective predictors of technical failure. CONCLUSIONS: ENGBD was effective in resolving acute cholecystitis; however, this modality was technically challenging and had a limited suc-cess rate. Because of technical difficulties, ENGBD should be reserved for limited indications. (Gut Liver, 2015;9239-246).

A novel dry model for practicable sphincterotomy and precut needle knife sphincterotomy.

Aim. We aimed to develop a simulation dry model for endoscopic sphincterotomy (ES) and needle knife precut sphincterotomy (NKP) and to evaluate its usefulness as a training simulator. Materials and Methods. An endoscopic retrograde cholangiopancreatography trainer was used as a duodenum, bile duct, and papilla simulator. A simulated papilla was created with a piece of rolled uncured ham, and ES and NKP were performed. Hands-on training was carried out using this model, and success and failure of the procedures were evaluated. A questionnaire survey was conducted among the participants to assess the performance and usefulness of the dry model for ES and NKP training. Results. Twenty-two endoscopists participated in the hands-on training using this dry model. ES was successful in 33 out of 34 attempts (97%) whereas NKP was successful in all 7 attempts (100%). Based on the results of the questionnaire survey, the median score for realism was 7 (range: 2-9) for ES and 8 for NKP on a scale of 1 to 10. Conclusions. The dry model using an uncured ham provides a condition closely similar to actual clinical practice and is useful as a training model for ES and NKP.

Direct peroral cholangioscopy using an ultraslim upper endoscope for biliary lesions.

BACKGROUND: The development of direct peroral cholangioscopy (DPOC) using an ultraslim endoscope simplifies biliary cannulation. The conventional techniques are cumbersome to perform and require advanced skills. The recent introduction of the guidewires and balloons has improved the therapeutic outcomes. Here we describe an effective and easier method for performing DPOC using an ultraslim upper endoscope. METHODS: Indications for DPOC were the presence of stones on follow-up of patients who had previously undergone complete sphincteroplasty, including endoscopic sphincterotomy or endoscopic papillary large balloon dilatation. Fifteen patients underwent DPOC. An ultraslim endoscope was inserted perorally and was advanced into the major papilla. The ampulla of Vater was visualized by retroflexing the endoscope in the distal second portion of the duodenum, and then DPOC was performed using a wire-guided cannulation technique with an anchored intraductal balloon catheter. RESULTS: One patient failed in the treatment due to looping of the endoscope in the fornix of the stomach. Fourteen (93.3%) were successfully treated with our modified DPOC technique. Only one patient (6.7%) experienced an adverse event (pancreatitis) who responded well to conservative management. Residual stones of the common bile duct were completely removed in 3 patients. CONCLUSION: The modified method of DPOC is simple, safe and easy to access the bile duct.

Newly designed J-shaped tip guidewire: a preliminary feasibility study in wire-guided cannulation.

AIM: To perform wire-guided cannulation using a newly designed J-shaped tip guidewire, and to verify feasibility and safety for use. METHODS: The study was conducted on endoscopic retrograde cholangiopancreatography (ERCP) patients with naïve papilla undergoing diagnosis and treatment of biliary diseases between September 2011 and July 2012. We performed ERCP in a succession of 50 cases with a J-shaped tip guidewire. The first insertion attempt began with a trainee who had 5 min to complete cannulation, followed if necessary by the trainer for another 5 min. We assessed the primary success rate of selective biliary cannulation within 10 min and adverse events such as post-ERCP pancreatitis (PEP), bleeding or perforation. RESULTS: The primary success rate was 90% (45/50) within 10 min, the initial success rate within 5 min by trainee staff was 76% (38/50). The rate of PEP was 6% (3/50), but all 3 cases were mild pancreatitis. All patients were managed successfully with conservative treatment. There was no bleeding or perforation. CONCLUSION: A newly designed J-shaped tip guide-wire has the possibility to facilitate selective biliary cannulation for ERCP and appears to be safe.

Efficacy, Safety, and Long-Term Follow-Up Results of EUS-Guided Transmural Drainage for Pancreatic Pseudocyst.

Background and Aim. EUS-guided transmural drainage (EUS-GTD) is now considered a minimally invasive and effective alternative to surgery for drainage of symptomatic pancreatic pseudocysts. However, the technique is rather difficult, and sometimes serious complications occur to patients undergoing this procedure. We retrospectively evaluated efficacy, safety, and long-term follow-up results of EUS-GTD for pancreatic pseudocyst. Methods. Sixty-seven patients with pancreatic pseudocyst who underwent EUS-GTD from April 2000 to March 2011 were enrolled. We retrospectively evaluated (1) technical success, (2) clinical success, (3) adverse event of procedure, and (4) long-term follow-up results. Results. Total technical success rate was 88%. Ninety-one percent of external drainage, 79% of internal drainage, and 66% of puncture and aspiration only achieved clinical success. There was only one case with an adverse event, perforation (1.5%). The case required emergency operation. Total recurrence rate was 23.9%. Median follow-up period was 33.9 months. The recurrence rates in the cases of stent remaining, spontaneously dislodged, removed on schedule, external tube removal, and aspiration only were 10.0%, 12.5%, 42.9%, 50%, and 0%, respectively. Conclusion. EUS-GTD is a relatively safe and effective therapeutic method. However, further analysis should be done by larger series to determine the method of EUS-GTD for pancreatic pseudocyst.

What is the preferred shape for an esophageal stent flange?

AIM: Self-expandable metallic stents (SEMS) for the gastrointestinal tract have different types of flanges at either the oral end or both ends to prevent stent migration. The effect of flange shape on the properties of SEMS, to our knowledge, has not been evaluated. The aim of this study was to measure the strain that a SEMS imposes on the adjacent wall and the anti-migration force (AF) exerted by three stents, each with a different flange shape. METHODS: Stents with one of three different flanges (flared, dumbbell, and barrel) were designed and then their strain and AF values were measured with apparatuses devised in our laboratory. RESULTS: Although the average maximal strain values at the flange were similar (508.4 µm/m, 513.3 µm/m and 486.4 µm/m for flared, dumbbell and barrel, respectively), strain values for each position differed among the three different types of stents. Strain values for the flared shape increased toward the stent end, reaching the maximum value. Maximal strain values for the dumbbell and barrel shapes were observed near the flange's midpoint. Maximal AF values differed significantly according to flange shape. Thus, the median maximal AF values were 1.85 newton, 1.35 newton, and 1.13 newton, for barrel, dumbbell and flared shapes, respectively. CONCLUSIONS: The performance of braided esophageal SEMS with barrel shaped flanges is superior to that of SEMS with dumbbell or flared flanges, based on the strain on the adjacent wall and the prevention of stent migration.

Comparison of modified introducer method with pull method for percutaneous endoscopic gastrostomy: prospective randomized study.

AIM: The pull method is associated with a high incidence of percutaneous endoscopic gastrostomy (PEG) site infection. The introducer method has been shown to be less likely to cause infection, because it avoids the passage of a tube through the oropharynx. The aim of the present study was to compare the modified introducer method with the pull method for PEG. METHODS: The study included patients who were scheduled for PEG from April 2008 to April 2010. The patients were randomly assigned to receive PEG by the pull method (Group I) or the modified introducer method (Group II). We evaluated the incidence of PEG site infection, some infection-associated parameters and other complications. Wound infections were evaluated in accordance with the Jain's score. RESULTS: Of 62 patients enrolled, 31 patients were assigned to each of the two groups. One patient in Group I died on the day after PEG. The cause of death and relationship with PEG were unclear. Excluding this patient, 61 were included in the per-protocol analysis. The incidence of peristomal infection within 1 week was slightly lower in Group II than in Group I, albeit not statistically significant (12.9% vs 23.3%, P = 0.3354). White blood cell count (WBC) and C-reactive protein (CRP) levels were significantly lower in Group II (WBC: P = 0.0345, CRP: P = 0.0346). None of the patients underwent surgical procedures for the treatment of peristomal infection. CONCLUSION: The results of the present study show that gastrostomy by the modified introducer method may be less likely, although not significantly, to cause peristomal infection than the pull method.