Comparison of covered self-expandable metallic stents with 12-mm and 10-mm diameters for unresectable malignant distal biliary obstructions: a prospective randomized trial.

BACKGROUND AND AIMS: Covered self-expandable metallic stents have longer patency than uncovered self-expandable metallic stents for unresectable malignant distal biliary obstruction because of the prevention of tumor ingrowth, and they are removable during reintervention. One main cause of recurrent biliary obstruction in covered self-expandable metallic stents is sludge formation, which can be prevented by using large-bore stents. We evaluated the treatment results of 12-mm and 10-mm covered self-expandable metallic stents for unresectable malignant distal biliary obstructions using a randomized controlled trial. METHODS: This study was conducted between May 2016 and January 2019 and included 81 consecutive patients with unresectable malignant distal biliary obstruction. The primary endpoint was the rate of nonrecurrent biliary obstruction at 6 months after stent placement. RESULTS: The primary endpoint in the 12-mm group was significantly higher than that in the 10-mm group (P = .0369). Therefore, the median time to recurrent biliary obstruction was 172 days in the 12-mm group and 120 days in the 10-mm group. The median time to recurrent biliary obstruction in the 12-mm group was significantly longer than that in the 10-mm group (P = .0168). Using the 12-mm covered self-expandable metallic stents and receiving chemotherapy were factors affecting the rate of recurrent biliary obstruction in the multivariate analysis. CONCLUSIONS: The 12-mm covered self-expandable metallic stents provide a longer time to recurrent biliary obstruction than do 10-mm covered self-expandable metallic stents for managing unresectable malignant distal biliary obstruction. (Clinical trial registration number: UMIN000016911.).

EUS-guided fine-needle biopsy sampling of solid pancreatic tumors with 3 versus 12 to-and-fro movements: a multicenter prospective randomized controlled study.

BACKGROUND AND AIMS: A novel EUS-guided fine-needle biopsy sampling (EUS-FNB) needle enabled physicians to obtain sufficient pathologic samples with fewer to-and-fro movements (TAFs) within the lesion. We compared the diagnostic yields of EUS-FNB with 3 and 12 TAFs at each puncture pass. METHODS: The primary endpoint of this multicenter, noninferiority, crossover, randomized controlled trial involving 6 centers was diagnostic sensitivity. Secondary endpoints were diagnostic accuracy and quantity and quality evaluation of EUS-FNB specimens. Length of the macroscopically visible core (MVC) and microscopic histologic quantity were used for quantitative evaluation. Macroscopic visual and microscopic histologic evaluations were performed for qualitative evaluation. RESULTS: Among 110 patients (220 punctures, 110 for 3 TAFs and 12 TAFs each), 105 (210 punctures) had malignant histology. Diagnostic sensitivity for malignancy of 3 TAFs (88.6%) was not inferior to that of 12 TAFs (89.5%; difference, -.9%; 95% confidence interval, -9.81 to 7.86). Diagnostic accuracy for malignancy was 92.7% for 3 TAFs and 94.6% for 12 TAFs. Overall median MVC length was 13.5 mm in both groups. The 3-TAF group had a significantly higher rate of score ≥3 on macroscopic visual quality evaluation than the 12-TAF group (71.8% vs 52.7%, P = .009). No significant intergroup differences existed in microscopic histologic quantity and quality evaluations (quantity evaluation, 88.2% for 3 TAFs vs 83.6% for 12 TAFs; quality evaluation, 90.0% for 3 TAFs vs 89.1% for 12 TAFs). CONCLUSIONS: Diagnostic sensitivity and accuracy of EUS-FNB with 3 TAFs were not inferior to those with 12 TAFs for solid pancreatic lesions. The 3-TAF group showed significantly less blood contamination in sampled tissues than the 12-TAF group. (Clinical trial registration number: UMIN000037309.).

A prospective multicenter study of endoscopic ultrasound-guided fine needle biopsy using a 22-gauge Franseen needle for pancreatic solid lesions.

BACKGROUND AND AIM: While encouraging data of endoscopic ultrasound (EUS)-guided fine-needle biopsy (EUS-FNB) using a 22-gauge Franseen needle have been reported, large-scale data of per pass and quantitative analyses are still lacking. METHODS: This was a multicenter prospective study of EUS-FNB using the 22-gauge Franseen needle for a pancreatic solid lesion. Cytological and histological analyses per pass were evaluated and semi-quantitative analyses were performed on core tissue and blood contamination. Primary end-point was diagnostic accuracy per session. Prognostic factors were analyzed for diagnostic accuracy, sensitivity, core tissue, and blood contamination. RESULTS: A total of 629 passes were performed in 244 cases at 14 centers between 2018 and 2019. The median tumor size was 29 mm, and the puncture was transduodenal in 43%. The median pass number was 2. Diagnostic accuracy per session, at a first pass, and per pass were 93%, 90%, and 88%. In 198 cases with pancreatic cancer, diagnostic sensitivity per session, at a first pass, and per pass were 94%, 89%, and 89%. The rates of core tissue score of 4 and blood contamination score of 3 were 50% and 47%. The adverse event rate was 1.6%. In the multivariate analysis, tumor size ≤20 mm (odds ratio [OR] of 0.46, P = 0.03), transduodenal puncture (OR of 0.53, P = 0.04), and suction (OR of 0.16, P = 0.01) were associated with lower diagnostic accuracy. CONCLUSIONS: The EUS-FNB using the 22-gauge Franseen needle for pancreatic solid lesions showed high per pass and overall diagnostic accuracy.

Usefulness of a target sample check illuminator in the detection of target specimens in endoscopic ultrasound-guided fine-needle biopsy samples: Multicenter prospective study.

OBJECTIVES: Endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) uses a thin needle, rendering unclear whether the collected sample contains pathological evidence. We examined the usefulness of our target sample check illuminator (TSCI) through a multicenter prospective trial. METHODS: We included 52 consecutive patients. After assessing EUS-FNB samples by conventional (visual observation) and TSCI methods, we evaluated consistency with the histopathological diagnosis. We compared the target sample confirmation rate between conventional and TSCI methods and evaluated the diagnostic ability separately. RESULTS: Comparison between the conventional and TSCI methods revealed the following: (i) for all cases: sensitivity, 51.0% (25/49) vs. 95.9% (47/49) (P = 0.001); specificity, 100% (3/3) vs. 66.7% (2/3); positive predictive value (PPV), 100% (25/25) vs. 97.9% (47/48); and negative predictive value (NPV), 11.1% (3/27) vs. 50.0% (2/4) (P = 0.002); (ii) for pancreatic masses: sensitivity, 28.0% (7/25) vs. 96.0% (24/25) (P < 0.001); specificity, 100% (2/2) vs. 100% (2/2); PPV, 100% (7/7) vs. 100% (24/24); and NPV, 10.0% (2/20) vs. 66.7% (2/3) (P < 0.001) (the TSCI method showed significantly better sensitivity and NPV than the conventional method); and (iii) for lymph node tumors: sensitivity, 75.0% (18/24) vs. 95.8% (23/24) (P = 0.025); specificity, 100% (1/1) vs. 0% (0/1); PPV, 100% (18/18) vs. 95.8% (23/24); and NPV, 14.3% (1/7) vs. 0% (0/1). CONCLUSIONS: The TSCI improved the sensitivity, NPV, and accuracy of target sample confirmation for pancreatic mass EUS-FNB. Although the proportion of samples not including a target region was quite low, which could strongly influence our results, the TSCI method can be used in EUS-FNB when rapid on-site evaluation cannot be performed. (A multicenter prospective study for the utility of a target sample check illuminator, Clinical Trial ID: UMIN000023349).

Adverse events of endoscopic ultrasound-guided fine-needle aspiration for histologic diagnosis in Japanese tertiary centers: Multicenter retrospective study.

BACKGROUND AND AIMS: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is used for the histopathological diagnosis of any type of gastrointestinal disease. Few adverse events are experienced with this procedure; however, the actual rate of adverse events remains unclear. This study aimed to clarify the current status of cases that experienced adverse events related to the EUS-FNA procedure used for histopathologic diagnoses. METHODS: A retrospective analysis of cases with EUS-FNA-related adverse events in Japanese tertiary centers was conducted by assessing the following clinical data: basic case information, FNA technique, type of procedural adverse events, and prognosis. RESULTS: Of the 13,566 EUS-FNA cases overall, the total number of cases in which adverse events related to EUS-FNA occurred was 234. The incidence of EUS-FNA-related adverse events was ~1.7%. Bleeding and pancreatitis cases accounted for ~49.1% and 26.5% of all adverse events, respectively. Bleeding was the most common adverse event with only seven cases requiring blood transfusion. In cases with neuroendocrine tumors, pancreatitis was the most frequent adverse event. Needle tract seeding because of EUS-FNA was observed during the follow-up period in only ~0.1% of cases with pancreatic cancer. There was no mortality because of adverse events caused by EUS-FNA. CONCLUSIONS: This study revealed that the adverse events-related EUS-FNA for histopathologic diagnoses were not severe conditions, and had low incidence.

Multicenter randomized trial of endoscopic papillary large balloon dilation without sphincterotomy versus endoscopic sphincterotomy for removal of bile duct stones: MARVELOUS trial.

BACKGROUND : Endoscopic papillary large balloon dilation (EPLBD) has been increasingly used for the management of large common bile duct (CBD) stones. Although EPLBD is often preceded by endoscopic sphincterotomy (EST), EPLBD alone without EST has been increasingly reported as an alternative to EST for large CBD stones. METHODS : This multicenter randomized trial was conducted at 19 Japanese institutions to compare the efficacy and safety of EPLBD alone versus EST for the removal of large (≥ 10 mm) CBD stones. The primary end point was complete stone removal in a single session. The secondary end points included: overall complete stone removal, lithotripsy use, procedure time, adverse events, and cost. RESULTS: 171 patients with large CBD stones were included in the analysis. The rate of single-session complete stone removal was significantly higher in the EPLBD-alone group than in the EST group (90.7 % vs. 78.8 %; P = 0.04). Lithotripsy use was significantly less frequent in the EPLBD group than in the EST group (30.2 % vs. 48.2 %; P = 0.02). The rates of early adverse events were comparable between the two groups: rates of overall adverse events were 9.3 % vs. 9.4 % and of pancreatitis were 4.7 % vs. 5.9 % in the EPLBD and EST groups, respectively. The procedure costs were $1442 vs. $1661 in the EPLBD and EST groups, respectively (P = 0.12). CONCLUSION : EPLBD without EST for the endoscopic treatment of large CBD stones achieved a significantly higher rate of complete stone removal in a single session compared with EST, without increasing adverse events.

Endoscopic ultrasound-guided tissue acquisition with or without macroscopic on-site evaluation: randomized controlled trial.

BACKGROUND: The use of macroscopic on-site evaluation (MOSE) to estimate the adequacy of a specimen for histological diagnosis during endoscopic ultrasound (EUS)-guided fine-needle tissue acquisition (FNTA) has recently been advocated. This study aimed to evaluate the diagnostic yield of MOSE compared with conventional EUS-FNTA without rapid on-site evaluation (ROSE). METHODS: This was an international, multicenter, prospective, randomized controlled study. After providing informed consent, consecutive adult patients referred for EUS-FNTA for solid lesions larger than 2 cm were randomized to a MOSE arm or to a conventional arm without ROSE. A designated cytopathologist from each center performed all cytopathological examinations for that center and was blinded to the randomization results. The primary outcome measure was the diagnostic yield, and the secondary outcomes included sensitivity, specificity, positive predictive value, negative predictive value, diagnostic accuracy, and the rate of procedure-related complications. RESULTS: 244 patients (122 conventional, 122 MOSE) were enrolled during the study period. No significant differences between the two arms were found in procedure time or rate of procedure-related adverse events. The diagnostic yield for the MOSE technique (92.6 %) was similar to that for the conventional technique (89.3 %; P  = 0.37), with significantly fewer passes made (median: conventional 3, MOSE 2; P  < 0.001). CONCLUSIONS: EUS-FNTA with the MOSE technique provided a similar diagnostic yield to conventional EUS-FNTA technique in the absence of ROSE but with fewer passes. This technique can be used when ROSE is not available.

Safety and efficacy of endoscopic ultrasound-guided fine needle aspiration for pancreatic masses: A prospective multicenter study.

OBJECTIVES: Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for solid pancreatic lesions has high diagnostic yield. However, few prospective multicenter studies have been performed. We performed a prospective cohort study to evaluate the efficacy and safety of EUS-FNA for diagnosis of solid pancreatic lesions. METHODS: This prospective cohort study involved five hospitals in Japan. The primary outcome was sensitivity of EUS-FNA for diagnosing malignant lesions. We also evaluated parameters of diagnostic sufficiency and the safety of EUS-FNA. RESULTS: In total, 246 patients were enrolled. The absolute values of the parameters evaluated showed no significant differences; however, the percentage changes in the white blood cell counts and C-reactive protein levels after examination were significantly higher, and the percentage change in hemoglobin concentrations was significantly lower. The minor and major complication rates at the time of puncture, 24 h, 7 days and 28 days were 4.1%, 2.8%, 1.6%, and 0.0%, respectively. The true complication rate was 1.2%. The diagnostic sensitivity, specificity, accuracy, positive predictive value, and negative predictive value were 97.2%, 88.0%, 96.2%, 100%, and 81.4%, respectively. CONCLUSIONS: EUS-FNA for solid pancreatic lesions has high diagnostic yield and is safe, consistent with previously studies.

Comparison of late adverse events after endoscopic sphincterotomy versus endoscopic papillary large balloon dilation for common bile duct stones: A propensity score-based cohort analysis.

BACKGROUND AND AIM: Endoscopic sphincterotomy (ES) is a standard procedure for the treatment of common bile duct stones (CBDS). Endoscopic papillary large balloon dilation (EPLBD) is emerging as an effective method to treat difficult CBDS, providing several advantages over ES without increasing early adverse events (AE). However, the late AE of EPLBD have not yet been well studied. The aim of the present study was to compare late AE after EPLBD versus ES for the treatment of CBDS using a propensity score-based cohort analysis. METHODS: Propensity score matching was introduced to reduce the possible bias in baseline characteristics between two treatment groups and formed the matched cohort including 240 patients. Primary endpoint was cumulative as well as estimated 1-year and 3-year late AE rates. Secondary outcome was the incidence of early AE. RESULTS: Cumulative late AE rates were 12.5% and 16.7% in the ELPBD and ES groups (P = 0.936) with a median follow-up period of 915.5 and 1544.5 days, respectively. Estimated 1-year and 3-year late AE rates were 8.4% and 13.1% in the EPLBD group and 5.0% and 15.0% in the ES group, respectively. In multivariate analysis, ≥two procedures were identified as independent risk factors for late AE. Overall early AE rate did not differ between the groups. CONCLUSION: In the present study, late AE rate after EPLBD showed no significant difference compared with that after ES, which had a relatively long follow-up period. Therefore, EPLBD could be used for the treatment of CBDS, if CBDS are considered difficult to treat. Clinical Trial Registry: UMIN000027798.

Hybrid procedure combining endoscopic gallbladder lavage and internal drainage with elective cholecystectomy for acute cholecystitis: A prospective pilot study (The BLADE study).

BACKGROUND AND AIM: Percutaneous transhepatic drainage is the most common method for non-operative gallbladder drainage, but the technique does have several disadvantages because of its invasive nature and requirement for continuous drainage. To overcome these disadvantages, we developed a novel procedure, endoscopic gallbladder lavage followed by stent placement, carried out in a single endoscopic session. Our aim was to prospectively evaluate the efficacy and safety of this procedure in patients with acute cholecystitis. METHODS: Patients diagnosed with moderate cholecystitis at four tertiary care centers were enrolled in this study. We initially placed a 5-Fr tube to carry out gallbladder lavage. The tube was then cut to the optimal length and placed as a stent. Main outcomes were procedural and clinical success rates. RESULTS: The procedure was attempted in 40 patients and was successful in 30 (75.0%). Minor adverse events occurred in two (5.0%) patients: perforation of the cystic duct by the guidewire in one patient and pancreatitis in the other. Among the 30 patients in whom the procedure was successfully done, clinical resolution was obtained in 29 (96.6%). Elective cholecystectomy was carried out in 37 patients (92.5%), with a median delay after drainage of 42 days (range, 12-138 days). There were no adverse events during the waiting period. CONCLUSIONS: Gallbladder rinsing followed by internal drainage using a 5-Fr nasobiliary tube is considered an effective and safe alternative to other techniques, providing an acceptable success rate in patients with acute cholecystitis prior to elective surgery. CLINICAL TRIAL INFORMATION: http://www.umin.ac.jp/ctr/index.htm (ID: UMIN-000009680).

Endoscopic ultrasound-guided antegrade biliary stenting for unresectable malignant biliary obstruction in patients with surgically altered anatomy: Single-center prospective pilot study.

BACKGROUND AND AIM: Endoscopic retrograde cholangiography (ERCP) with biliary stenting for the treatment of unresectable malignant biliary obstruction (MBO) is challenging among patients with surgically altered anatomy. Endoscopic ultrasound-guided antegrade biliary stenting (EUS-ABS) was introduced as an alternative biliary drainage method, although it has not yet been well studied. In this single-center prospective pilot study, we aimed to evaluate the feasibility and safety of EUS-ABS for MBO in patients with surgically altered anatomy. METHODS: EUS-ABS for MBO was attempted in patients with surgically altered anatomy. In EUS-ABS, the bile duct in the left lobe was accessed from the intestine under EUS guidance, and a guidewire was placed. Thereafter, an uncovered metallic stent was deployed at the MBO through the fistula. All devices were then removed. Technical, clinical, and adverse event rates, as well as patient characteristics and procedure details, were evaluated. RESULTS: Twenty patients (10 women; median age, 69 years) were enrolled in the present study. Technical and clinical success rates of EUS-ABS were both 95% (19/20). In one patient, unsuccessful EUS-ABS as a result of failed visualization of the left lobe of the liver with EUS was salvaged with percutaneous biliary drainage. Rate of adverse events was 20% (4/20), including mild pancreatitis in three patients and mild fever in one patient, which were successfully managed conservatively. CONCLUSIONS: EUS-ABS for MBO in patients with surgically altered anatomy was a feasible and safe procedure. Further large scale comparison studies are needed to confirm its efficacy (Clinical Trial Registration Number: UMIN000008589).

Intrahepatic cholangiocarcinoma producing granulocyte colony-stimulating factor and parathyroid hormone-related protein.

A 78-year-old man was referred to our hospital with suspected liver abscess. Fever and inflammatory reaction resolved after percutaneous drainage and administration of antibiotics. However, leukocyte count was remarkably increased, and hypercalcemia was noted. The liver mass was also enlarged, as observed in the follow-up abdominal CT scans. Therefore, a percutaneous needle biopsy was performed, and the histopathological findings indicated the presence of adenocarcinoma. Additional blood examination revealed high serum levels of granulocyte colony-stimulating factor (G-CSF) and parathyroid hormone-related protein (PTHrP). Lastly, the patient was diagnosed with cholangiocarcinoma producing G-CSF and PTHrP. Chemoradiotherapy with S-1 was initiated, which was partially effective. However, the patient died 134 days after initiating the therapy. Only two cases of cholangiocarcinoma producing G-CSF and PTHrP have been reported to date. Here we reported an additional case of cholangiocarcinoma producing G-CSF and PTHrP.

EUS-guided rendezvous for difficult biliary cannulation using a standardized algorithm: a multicenter prospective pilot study (with videos).

BACKGROUND AND AIMS: Biliary cannulation is necessary in therapeutic ERCP for biliary disorders. EUS-guided rendezvous (EUS-RV) can salvage failed cannulation. Our aim was to determine the safety and efficacy of EUS-RV by using a standardized algorithm with regard to the endoscope position in a prospective study. METHODS: EUS-RV was attempted after failed cannulation in 20 patients. In a standardized approach, extrahepatic bile duct (EHBD) cannulation was preferentially attempted from the second portion of the duodenum (D2) followed by additional approaches to the EHBD from the duodenal bulb (D1) or to the intrahepatic bile duct from the stomach, if necessary. A guidewire was placed in an antegrade fashion into the duodenum. After the guidewire was placed, the endoscope was exchanged for a duodenoscope to complete the cannulation. RESULTS: The bile duct was accessed from the D2 in 10 patients, but from the D1 in 5 patients and the stomach in 4 patients because of no dilation or tumor invasion at the distal EHBD. In the remaining patient, biliary puncture was not attempted due to the presence of collateral vessels. The guidewire was successfully manipulated in 80% of patients: 100% (10/10) with the D2 approach and 66.7% (6/9) with other approaches. The overall success rate was 80% (16/20). Failed EUS-RV was salvaged with a percutaneous approach in 2 patients, repeat ERCP in 1 patient, and conservative management in 1 patient. Minor adverse events occurred in 15% of patients (3/20). CONCLUSIONS: EUS-RV is a safe and effective salvage method. Using EUS-RV to approach the EHBD from the D2 may improve success rates.

No Benefit of Oral Diclofenac on Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.

BACKGROUND: Pancreatitis following endoscopic retrograde cholangiopancreatography (ERCP) is a serious complication. Rectal diclofenac (100 mg) has been shown to reduce the incidence of pancreatitis; however, this dosage form is unavailable in several countries. AIMS: We aimed to investigate the preventive effect of oral diclofenac on pancreatitis after ERCP in a multicenter, randomized, prospective, placebo-controlled, double-blind trial. METHODS: Patients undergoing a first ERCP in seven high-volume centers between July 2012 and August 2014 were considered eligible. Participants were administered oral diclofenac (50 mg) or placebo before and after ERCP. The primary endpoint was the incidence of pancreatitis. A subgroup analysis was performed for patients at high or low risk of pancreatitis. Secondary endpoints were pancreatic enzyme levels (amylase and lipase). RESULTS: We initially enrolled 430 patients (216 in the diclofenac and 214 in the placebo group), and 23 were excluded after randomization. The overall incidence of pancreatitis was 9.8 % (20/205) and 9.4 % (19/202) in the diclofenac and placebo groups, respectively (p = 0.90). The incidence of pancreatitis was 20.3 % (13/64) and 21.3 % (13/61) in patients at high risk of pancreatitis (p = 0.78) and 5.0 % (7/141) and 4.3 % (6/141) in patients at low risk of pancreatitis in the diclofenac and placebo groups (p = 0.94), respectively. There were no significant differences in serum amylase and lipase levels between the two groups before and 24 h after ERCP. CONCLUSIONS: Oral administration of diclofenac before and after ERCP showed no benefit in the prevention of pancreatitis. CLINICAL TRIALS REGISTRY NO: UMIN000008109.

Significance of Endoscopic Sphincterotomy Preceding Endoscopic Papillary Large Balloon Dilation in the Management of Bile Duct Stones.

BACKGROUND: Endoscopic papillary large balloon dilation (EPLBD) is safe and effective in management of common bile duct stones (CBDS). Endoscopic sphincterotomy (EST) prior to EPLBD has been performed as a standard procedure. However, the significance of EST prior to EPLBD has not been well studied yet. AIMS: To compare the clinical outcomes of EPLBD with and without EST to evaluate the significance of EST. METHODS: Between April 2010 and March 2015, a total of 82 patients with naïve papillae underwent EPLBD with or without EST for the management of CBDS. A retrospective analysis compared the efficacy and safety of EPLBD with and without EST. RESULTS: Basic patient characteristics were not significantly different between the groups that underwent EPLBD with EST (n = 27) and without EST (n = 55). Complete stone removal rates were similar between the groups (100 % in the EST group and 98 % in the non-EST group, p = 1.00). There was no significant difference in the median balloon size (13 mm in both groups, p = 0.445), rate of application of mechanical lithotripsy (26 vs. 35 % in the EST and non-EST groups, respectively, p = 0.463), or the median procedure time (38 vs. 34 min in the EST and non-EST groups, respectively, p = 0.682). The overall adverse event rates were not statistically different (4 vs. 7 % in the EST and non-EST groups, respectively, p = 1.00). Pancreatitis, cholangitis, and hemorrhage rates were also similar in both groups. CONCLUSIONS: EST prior to EPLBD may be unnecessary since this study did not demonstrate its benefits.

Macroscopic on-site quality evaluation of biopsy specimens to improve the diagnostic accuracy during EUS-guided FNA using a 19-gauge needle for solid lesions: a single-center prospective pilot study (MOSE study).

BACKGROUND: Although rapid on-site cytologic evaluation provides high efficacy of EUS-guided FNA (EUS-FNA), its availability is limited. Alternatively, macroscopic on-site quality evaluation (MOSE) may increase the efficacy of EUS-FNA. OBJECTIVE: To assess the efficacy of MOSE in estimating the adequacy of histologic core specimens obtained by EUS-FNA using a standard 19-gauge needle (19GN) for solid lesions. DESIGN: A prospective pilot study. SETTING: Tertiary-care referral center. PATIENTS: One hundred patients with solid lesions (n = 111 lesions). INTERVENTIONS: EUS-FNA using 19GN MAIN OUTCOME MEASUREMENTS: The relation of a macroscopic visible core (MVC) in the FNA specimens on MOSE with histologic core and the diagnostic yields were studied. RESULTS: The feasibility of EUS-FNA using a 19GN was 99%. The final diagnoses were malignancy in 83 lesions and benign in 28. MOSE revealed MVC in 91.1% with the median length of 8 mm. Histologic core was confirmed in 78.9%. The receiver-operating characteristic curve of the length of MVC for the presence of histologic core showed the cut-off MVC length of 4 mm with area under the curve of .893. Comparisons of per-pass diagnostic yields showed significantly superior histologic, cytologic, and overall diagnostic yields in MVC ≥ 4 mm as compared with <4 mm. The multivariate analysis for false-negative pass identified lesion in the pancreas and MVC < 4 mm as significant risk factors. No adverse events were seen. LIMITATIONS: Single center, limited operators CONCLUSION: MVC of ≥4 mm on MOSE can be an indicator of specimen adequacy and can improve diagnostic yield; however, additional FNA may be recommended for pancreatic lesions. ( CLINICAL TRIAL REGISTRATION NUMBER: UMIN000010417.).

Endoscopic nasogallbladder tube or stent placement in acute cholecystitis: a preliminary prospective randomized trial in Japan (with videos).

BACKGROUND: There are currently no prospective, controlled trials of endoscopic transpapillary gallbladder drainage in patients with acute cholecystitis. OBJECTIVE: We evaluated the technical success rate and efficacy of endoscopic transpapillary gallbladder drainage by using either endoscopic nasogallbladder drainage (ENGBD) or endoscopic gallbladder stenting (EGBS) for patients with acute cholecystitis. DESIGN: Randomized, controlled study. SETTING: Tertiary-care referral centers. PATIENTS: Seventy-three consecutive patients with acute cholecystitis were randomized. INTERVENTIONS: ENGBD by using a 5F or 7F tube (n = 37) or EGBS (n = 36) by using a 7F stent. MAIN OUTCOME AND MEASUREMENTS: Technical success, clinical success, adverse events, and procedure-related pain score. RESULTS: The overall technical success rates in the ENGBD and EGBS groups were 91.9% and 86.1%, respectively (P > .05). The mean procedure times of ENGBD and EGBS were 20.3 ± 12.1 and 22.2 ± 14.5 minutes, respectively (P > .05). The overall clinical success rates by per protocol analysis were 94.1% and 90.3% in the ENGBD and EGBS groups, respectively, whereas the rates by intention-to-treat analysis were 86.5% and 77.8%, respectively (P > .05). Moderate adverse events were observed in the ENGBD (n = 2) and EGBS (n = 1) groups. The mean visual analog score of postprocedure pain in the ENGBD group was significantly higher than that in the EGBS group (1.3 ± 1.1 vs 0.4 ± 0.8, respectively; P < .001). LIMITATIONS: Small sample size and the participation of multiple endoscopists who may have different levels of experience in endoscopic transpapillary gallbladder drainage. CONCLUSIONS: Both ENGBD and EGBS appear to be suitable for the treatment of acute cholecystitis in patients who are poor candidates for emergency cholecystectomy. ( CLINICAL TRIAL REGISTRATION NUMBER: UMIN000012316.).

Effect of a stylet on a histological specimen in EUS-guided fine-needle tissue acquisition by using 22-gauge needles: a multicenter, prospective, randomized, controlled trial.

BACKGROUND: EUS-guided FNA (EUS-FNA) has become the most efficacious way to obtain specimens from a solid lesion adjacent to the GI tract. Previous reports regarding the use of a stylet during EUS-FNA were all based on cytological diagnosis and have showed no significant superiority in terms of diagnostic yield. OBJECTIVE: To clarify the noninferiority of EUS-FNA without a stylet (S-) compared with EUS-FNA with a stylet (S+) on histological assessment. DESIGN: A prospective, single-blind, randomized, controlled crossover study. SETTING: Five tertiary referral centers in Japan. PATIENTS: Patients referred for EUS-FNA of a solid lesion. INTERVENTION: EUS-FNA S+ and S- in a total of 4 alternate passes with randomization to S+ first or S- first. MAIN OUTCOME MEASUREMENTS: The primary endpoint was the acquisition rate of an appropriate and sufficient specimen for histological assessment. The secondary endpoints were cellularity, contamination, bloodiness, diagnostic ability, and diagnostic accuracy. RESULTS: We enrolled 107 patients (110 lesions) and analyzed 220 specimens each in the S+ and S- groups. The acquisition rate of appropriate and sufficient specimens in the S+ group was 121 of 220 (55.0%) and 122 of 220 (55.5%) in the S- group. The difference in the acquisition rate of the specimen (S- minus S+) based on the generalized estimating equation was 0.42% (95% confidence interval, -6.72% to 7.56%), which was less than 10% of the prespecified noninferiority margin of this study. With regard to cellularity, contamination, bloodiness score, diagnostic ability, and diagnostic accuracy, there were no significant differences between both groups. There were no dropouts in the study. LIMITATIONS: A variety of target lesions, multiple pathologists, lack of an assessment of intraobserver and interobserver variability, and a single-blind study for the pathologists. CONCLUSION: EUS-FNA S- is noninferior to EUS-FNA S+ on histological assessment. ( CLINICAL TRIAL REGISTRATION NUMBER: UMIN000008695.).

High and low negative pressure suction techniques in EUS-guided fine-needle tissue acquisition by using 25-gauge needles: a multicenter, prospective, randomized, controlled trial.

BACKGROUND: EUS-guided FNA (EUS-FNA) has a high diagnostic accuracy for pancreatic diseases. However, although most reports have typically focused on cytology, histological tissue quality has rarely been investigated. The effectiveness of EUS-FNA combined with high negative pressure (HNP) suction was recently indicated for tissue acquisition, but has not thus far been tested in a prospective, randomized clinical trial. OBJECTIVE: To evaluate the adequacy of EUS-FNA with HNP for the histological diagnosis of pancreatic lesions by using 25-gauge needles. DESIGN: Prospective, single-blind, randomized, controlled crossover trial. SETTING: Seven tertiary referral centers. PATIENTS: Patients referred for EUS-FNA of pancreatic solid lesions. From July 2011 to April 2012, 90 patients underwent EUS-FNA of pancreatic solid masses by using normal negative pressure (NNP) and HNP with 2 respective passes. The order of the passes was randomized, and the sample adequacy, quality, and histology were evaluated by a single expert pathologist. INTERVENTION: EUS-FNA by using NNP and HNP. MAIN OUTCOME MEASUREMENTS: The adequacy of tissue acquisition and the accuracy of histological diagnoses made by using the EUS-FNA technique with HNP. RESULTS: We found that 72.2% (65/90) and 90% (81/90) of the specimens obtained using NNP and HNP, respectively, were adequate for histological diagnosis (P = .0003, McNemar test). For 73.3% (66/90) and 82.2% (74/90) of the specimens obtained by using NNP and HNP, respectively, an accurate diagnosis was achieved (P = .06, McNemar test). Pancreatitis developed in 1 patient after this procedure, which subsided with conservative therapy. LIMITATIONS: This was a single-blinded, crossover study. CONCLUSION: Biopsy procedures that combine the EUS-FNA with HNP techniques are superior to EUS-FNA with NNP procedures for tissue acquisition. ( CLINICAL TRIAL REGISTRATION NUMBER: UMIN000005939.).