Short-Term Outcomes of Colorectal Stenting Using a Low Axial Force Self-Expandable Metal Stent for Malignant Colorectal Obstruction: A Japanese Multicenter Prospective Study.

(1) Background: Endoscopic colorectal stenting with high technical success and safety is essential in discussing the oncological outcomes for the management of malignant colorectal obstruction. Mechanical properties of self-expandable metal stents are usually considered to affect clinical outcomes. (2) Methods: A multicenter, prospective study was conducted in Japan. A self-expandable metal stent with low axial force was inserted endoscopically. The primary endpoint was clinical success, defined as the resolution of symptoms and radiological findings within 24 h. Secondary endpoints were technical success and adverse events. Short-term outcomes of 7 days were evaluated in this study. (3) Results: Two hundred and five consecutive patients were enrolled. Three patients were excluded, and the remaining 202 patients were evaluated. The technical and clinical success rates were 97.5% and 96.0%, respectively. Major stent-related adverse events included stent migration (1.0%), insufficient stent expansion (0.5%), and stent occlusion (0.5%). No colonic perforation was observed. There were two fatal cases (1%) which were not related to stent placement. (4) Conclusions: The placement of self-expandable metal stents with low axial force is safe with no perforation and showed high technical and clinical success rates in short-term outcomes for the management of malignant colorectal obstruction.

Uncovered versus covered metallic stents for the management of unresectable malignant distal biliary obstruction: a randomized multicenter trial.

OBJECTIVE: The treatment result of the uncovered metallic stent (uncovered MS) and covered metallic stent (covered MS) for unresectable malignant distal biliary obstruction is controversial. This time, we conducted this study to compare the efficacies and complication rates of uncovered MS and covered MS in unresectable malignant distal biliary obstructions at a prospective randomized multicenter trial. MATERIALS AND METHODS: From April 2014 to September 2018, patients with unresectable malignant distal biliary obstruction were randomly assigned to 2 groups: the uncovered MS group and the covered MS group. RESULTS: 92 treatment results patients were discussed. 48 patients were assigned to the uncovered MS group and 44 cases were assigned to the covered MS group. Both groups showed a drainage effect. No significant difference was found in the drainage effect between the 2 groups. The number of stent occlusion was significantly greater (p = .0467) in uncovered MS (43.8%) comparing with those in covered MS (22.7%). As the cause of stent occlusion, tumor ingrowth was significantly greater (p < .001) in the uncovered MS group (35.4%) than in the covered MS group (2.3%). The median stent patency period was significantly longer (p = .0112) in the covered MS group (455 days) than that of the uncovered MS group (301 days). A significant difference in the median survival period was not found between the 2 groups. CONCLUSIONS: Covered MS showed the possibility of extending the stent patency period by suppressing tumor ingrowth more than uncovered MS does. The UMIN Clinical Trial Registry number is UMIN000015093.

Predictive model of bleeding following endoscopic sphincterotomy for the treatment of choledocholithiasis in hemodialysis patients: A retrospective multicenter study.

BACKGROUND AND AIM: Although hemodialysis (HD) is a strong risk factor for postendoscopic sphincterotomy (ES) bleeding, additional risk factors in HD patients remain unclear. There is no model for predicting post-ES bleeding risk in HD patients. Therefore, we conducted a retrospective multicenter study to reveal these risk factors and develop a predictive model of post-ES bleeding in HD patients. METHODS: We retrospectively reviewed the medical records of HD patients who underwent ES at eight hospitals between January 2006 and December 2016, with post-ES bleeding as the main outcome measure. Univariate analyses were performed to extract possible risk factors for post-ES bleeding. Factors that were clinically important and statistically significant in our univariate analyses were then included in our logistic regression analysis for the development of a multivariate predictive model of post-ES bleeding. This predictive model was visualized using a predictive nomogram. RESULTS: Post-ES bleeding occurred in 20 (16.3%) of 123 HD patients. Based on clinically important factors and the results of our univariate analyses, platelet count, prothrombin time (international normalized ratio), and HD duration were included in our predictive model of post-ES bleeding. Receiver operating characteristic analysis found that this model had an area under the curve of 0.715 (95% confidence interval, 0.609-0.822). We developed a predictive nomogram based on these results. CONCLUSIONS: We demonstrated that post-ES bleeding is more common in HD patients than in the general population and succeeded in constructing a predictive model that can effectively identify HD patients at risk of post-ES bleeding.

Self-expandable metallic stenting as a bridge to surgery for malignant colorectal obstruction: pooled analysis of 426 patients from two prospective multicenter series.

BACKGROUND: Self-expandable metallic stenting (SEMS) for malignant colorectal obstruction (MCO) as a bridge to elective surgery (BTS) is a widely used procedure. The aim of this study was to assess short-term outcomes of SEMS for MCO as BTS. METHODS: This study analyzed pooled data from BTS patients who were enrolled in two multicenter prospective single-arm observational clinical studies that used different stent types. Both studies were conducted by the Japan Colonic Stent Safe Procedure Research Group (JCSSPRG). The first study evaluated the WallFlex™ colonic stent for BTS or palliative treatment (PAL) from May 2012 to October 2013 and the second evaluated the Niti-S™ colonic stent from October 2013 to May 2014. Fifty-three facilities in Japan participated in the studies. Before each study started, the procedure had been shared with the participating institutions by posting details of the standard methods of SEMS placement on the JCSSPRG website. Patients were followed until discharged after surgery. RESULTS: A total of 723 consecutive patients were enrolled in the two studies. After excluding nine patients, the remaining 714 patients were evaluated as a per-protocol cohort. SEMS placement was performed in 426 patients (312 WallFlex and 114 Niti-S) as BTS and in 288 as PAL. In the 426 BTS patients, the technical success rate was 98.1% (418/426). The clinical success rate was 93.8% (392/418). SEMS-related preoperative complications occurred in 8.5% of patients (36/426), perforations in 1.9% (8/426), and stent migration in 1.2% (5/426). Primary anastomosis was possible in 91.8% of patients (391/426), 3.8% of whom (15/393) had anastomosis leakage. The overall stoma creation rate was 10.6% (45/426). The postoperative complication rate was 16.9% (72/426) and mortality rate was 0.5% (2/426). CONCLUSIONS: SEMS placement for MCO as BTS is safe and effective with respect to peri-procedural outcomes. Further investigations are needed to confirm long-term oncological outcomes.

Lactococcus lactis cholangitis and bacteremia identified by MALDI-TOF mass spectrometry: A case report and review of the literature on Lactococcus lactis infection.

Lactococcus lactis is a rare causative organism in humans. Cases of L. lactis infection have only rarely been reported. However, because it is often difficult to identify by conventional commercially available methods, its incidence may be underestimated. We herein report the case of a 70-year-old man with cholangiocarcinoma who developed L. lactis cholangitis and review previously reported cases of L. lactis infection. Our case was confirmed by matrix-assisted desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS). This case shows L. lactis is a potential causative pathogen of cholangitis and that MALDI-TOF MS can be useful for the rapid and accurate identification of L. lactis infection. We searched the literature for published case reports on cholangitis and any other infections caused by L. lactis, and thereby identified 36 cases, including our case. At least 66.7% (n = 24) of the cases had significant underlying conditions; 15 of the cases involved patients with an immunocompromised status. At least 41.7% (n = 15) had a significant food consumption history, such as the consumption of unpasteurized dairy products. The clinical sources of L. lactis were diverse and endocarditis was the most common diagnosis (n = 8), followed by hepatobiliary infection (n = 6), central nervous system infection (n = 5), and peritonitis (n = 4). The prognosis was favorable in most cases.

Factors related to difficult self-expandable metallic stent placement for malignant colonic obstruction: A post-hoc analysis of a multicenter study across Japan.

BACKGROUND AND AIM: Colorectal cancer patients often present with large bowel obstruction. Elective placement of a self-expandable metallic stent (SEMS) can relieve obstruction, but can be challenging. Previous studies have compared cases by outcomes only, but the present study investigated successful cases only to identify factors related to prolonged and difficult SEMS placement in patients with malignant colonic obstruction. METHODS: A post-hoc analysis of a multicenter clinical trial conducted between March 2012 and October 2013 at 46 facilities across Japan (UMIN000007953) was carried out; 511 patients who required SEMS placement for acute colorectal obstruction or symptomatic stricture secondary to malignant neoplasm were enrolled. Technical success rates and procedure times were recorded. Clinical and interventional parameters were investigated for their potential effect on procedure time by univariate and multivariate analyses. RESULTS: Technical success rate of SEMS placement was 98%. Median procedure time was 30 (range, 4-170) min. In 27% of patients, procedure time exceeded 45 min, indicating technically difficult placement. Multivariate analyses showed significant associations between technically difficult placement and a ColoRectal Obstruction Scoring System (CROSS) score of 0 before SEMS placement (odds ratio [OR], 1.6; P < 0.05), tumor site in the right colon (OR, 2.5; P < 0.0001), stricture length ≥5 cm (OR, 2.2; P < 0.001), peritoneal carcinomatosis (OR, 1.7; P < 0.05), and multiple SEMS placement (OR, 8.0; P < 0.01). CONCLUSION: Clinicians must anticipate technical challenges in cases with peritoneal carcinomatosis, a CROSS score of 0, or expansive strictures; such cases require experienced clinicians to carry out SEMS placement.

Hemodialysis is a strong risk factor for post-endoscopic sphincterotomy bleeding in patients with choledocholithiasis.

BACKGROUND AND STUDY AIMS: Hemodialysis (HD) is considered one of the risk factors for post-endoscopic sphincterotomy (ES) bleeding. Therefore, we conducted a retrospective study to evaluate HD as a risk factor for post-ES bleeding in patients with choledocholithiasis. PATIENTS AND METHODS: We used the post-ES bleeding rate as the main outcome measure. To evaluate the influence of HD on the risk of post-ES bleeding, logistic regression and propensity score analyses were conducted. In addition, univariate analysis-based comparisons of various clinical parameters (as secondary outcome measures) were performed between the patients in the HD and non-HD groups that experienced post-ES bleeding. RESULTS: A total of 1518 patients were enrolled. In the multivariate analysis, a platelet count of < 50,000, anticoagulant therapy, bleeding during ES, and HD were found to be significantly associated with post-ES bleeding (odds ratio [OR]: 35.30, 95 % confidence interval [CI]: 3.81 - 328.00; OR: 4.39, 95 % CI: 1.53 - 12.60; OR: 4.28, 95 % CI: 2.30 - 7.97; and OR: 13.30, 95 % CI: 5.78 - 30.80, respectively). Propensity score matching created 28 matched pairs. Propensity score analysis showed that the risk difference between the groups was 0.214 (95 % CI: 0.022 - 0.407). In a comparison between the patients in the HD and non-HD groups that suffered post-ES bleeding, it was found that the post-ES bleeding was significantly more severe in the HD group (p = 0.033), and massive blood transfusions and long periods of hospitalization were more frequently required in the HD group (p = 0.008 and p < 0.001, respectively). CONCLUSION: HD is an independent risk factor for post-ES bleeding and makes post-ES bleeding more serious.

Gastroduodenal Intussusception with a Gastric Gastrointestinal Stromal Tumor Treated by Endoscopic Submucosal Dissection.

A 95-year-old Japanese woman presented to our hospital with intermittent vomiting and several episodes of melena. Abdominal computed tomography revealed intussusception of the gastric tumor into the duodenum. After endoscopic reduction, endoscopic ultrasonography identified a hypoechogenic lesion limited to the submucosal layer. Endoscopic resection was performed as a localized treatment for the prevention of recurrent gastroduodenal intussusception. To our knowledge, there have been no other reports describing a gastric gastrointestinal stromal tumor presenting with gastroduodenal intussusception and treated using an endoscopic submucosal dissection technique.

Clinical utility of 0.025-inch guidewire VisiGlide2TM in the endoscopic retrograde cholangiopancreatography-related procedures.

AIM: To examine the result of the use of 0.025-inch guidewire (GW) VisiGlide2TM as the first choice in the endoscopic retrograde cholangiopancreatography (ERCP)-related procedures without selecting the patient in a multicenter prospective study. METHODS: ERCP using 0.025-inch GW VisiGlide2TM as the first choice was conducted in patients who have needed ERCP, and its accomplishment rate of procedure, procedural time, incidence of accidental symptoms were compared with those of ERCP using 0.025-inch GW VisiGlideTM. RESULTS: The accomplishment rate of procedure was 97.5% (197/202), and procedural time was 23.930 ± 16.207 min. The accomplishment rate of procedure using 0.025-inch GW VisiGlideTM was 92.3% (183/195), and procedural time was 31.285 ± 19.122 min, thus the accomplishment rate of procedure was significantly improved and procedural time was significantly shortened (P < 0.05). Accidental symptoms by ERCP-related procedures were observed in 3.0% (6/202), and all were conservatively alleviated. CONCLUSION: When 0.025-inch GW VisiGlide2TM was used for ERCP-related procedure as the first choice, it showed high accomplishment rate of procedure and low incidence of accidental symptoms, suggesting it can be used as the universal GW. Clinical Trial Registry (UMIN0000016042).

Short-course antimicrobial treatment for acute cholangitis with Gram-negative bacillary bacteremia.

OBJECTIVES: The optimal antimicrobial treatment duration for patients with acute cholangitis with bacteremia remains unknown. The updated Tokyo Guidelines 2013 recommend a minimum duration of 2 weeks only when bacteremia with Gram-positive cocci is present. Since May 2013, a shorter antimicrobial treatment duration of under 2 weeks has been implemented at the authors' institution for acute cholangitis with Gram-negative bacillary bacteremia. The aim of the present study was to validate this modified practice. METHODS: A single-center retrospective cohort study was conducted. The antimicrobial treatment duration, 30-day mortality rate, and recurrence rate within 3 months were compared between patients treated before May 2013 and after May 2013. RESULTS: Ninety-one patients with cholangitis with bacteremia were analyzed. The median antimicrobial treatment duration was 14.5days in patients treated before May 2013 and 10.0days after May 2013 (p <0.001). While the 30-day mortality rate did not differ significantly, the recurrence rate was higher in those treated before May 2013 (5.7% vs. 0.0%, p=0.17 and 13.3% vs. 0.0%, p=0.03, respectively). The median treatment duration after May 2013 was 8days for grade I patients, 10days for grade II patients, and 11.5days for grade III patients. CONCLUSIONS: The results of this study suggest that acute cholangitis with Gram-negative bacillary bacteremia can be treated safely with a shorter antimicrobial treatment duration of <14 days.

Evaluation of the viability of hepatocellular carcinoma in the caudate lobe using contrast-enhanced endoscopic ultrasonography after transarterial chemoembolization.

A 71-year-old female was diagnosed with hepatocellular carcinoma (HCC). The tumor measured 65 mm in diameter and was located in the caudate lobe. Transarterial chemoembolization (TACE) was performed repeatedly; however, a follow-up dynamic computed tomography (CT) scan showed that the tumor remained viable. Thus, TACE was performed using drug-eluting beads that had been preloaded with epirubicin. Contrast-enhanced endoscopic ultrasonography (CE-EUS) was conducted for evaluating the treatment effects. First, we detected the internal part of the tumor. Then, a perflubutane suspension was injected intravenously. Next, CE-EUS was performed for the external ventral part of the tumor in the same manner. The perflubutane flowed into the tumor and spread into both its internal and external ventral regions. Thus, we considered that the tumor was still viable and planned to carry out TACE again. CE-EUS could be a useful tool for evaluating the treatment effects of TACE on HCC deep inside the liver.

Clinical outcomes of endoscopic ultrasound-guided ethanol injection for hepatocellular carcinoma in the caudate lobe.

Background and study aims: Accurately puncturing hepatocellular carcinomas (HCC) that arise from the caudate lobe is generally considered to be technically difficult. We conducted a retrospective study to evaluate the feasibility and safety (the therapeutic outcomes and adverse events) of endoscopic ultrasound (EUS)-guided ethanol injection as a novel treatment for HCC in the caudate lobe. Patients and methods: Twelve patients with early-stage HCC of the caudate lobe that were treated with EUS-guided ethanol injection at two tertiary referral centers were reviewed retrospectively. To evaluate the therapeutic effect of the treatment, a local control curve and an overall survival curve were constructed using the Kaplan-Meier method. Results: The mean follow-up duration was 31.0 months. The 1-year local control rate was 80.2 %, and recurrent lesions developed in 2 cases (after 3 and 9 months, respectively). The overall survival rate was 91.7 %, 75.0 %, and 53.3 % at 1, 2, and 3 years, respectively. Concerning procedure-related adverse events (AEs), 2 patients suffered episodes of fever lasting a few days; however, no serious AEs occurred. Conclusions: EUS-guided ethanol injection could be a useful treatment for early-stage HCC in the caudate lobe because of its simplicity and reduced invasiveness.

A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients.

BACKGROUND: Endoscopic stenting with a self-expandable metallic stent (SEMS) is a widely accepted procedure for malignant colonic obstruction. The Colonic Stent Safe Procedure Research Group conducted the present prospective feasibility study. METHODS: Our objectives were to estimate the safety and feasibility of SEMS placement as a bridge to surgery (BTS) for malignant colorectal obstruction. We conducted a prospective, observational, single-arm, multicenter clinical trial from March 2012 to October 2013. Each patient was treated with an uncovered WallFlex enteral colonic stent. Patients were followed up until discharge after surgery. RESULTS: A total of 518 consecutive patients were enrolled in this study. The cohort intended for BTS consisted of 312 patients (61 %), and the stent could be released in 305 patients. Technical and clinical success rates were 98 and 92 %, respectively. Elective surgery was performed in 297 patients, and emergency surgery was performed in eight patients for the treatment of complications. The overall preoperative complication rate was 7.2 %. Major complications, including perforation, occurred in 1.6 %, persistent colonic obstruction occurred in 1.0 %, and stent migration occurred in 1.3 % patients. The median time from SEMS to surgery was 16 days. Silent perforations were observed in 1.3 %. Open and laparoscopic surgery was performed in 121 and 184 patients, respectively. The tumor could be resected in 297 patients. The primary anastomosis rate was 92 %. The rate of anastomotic leakage was 4 %, and the overall stoma creation rate was 10 %. The median duration of hospitalization following surgery was 12 days. Overall postoperative morbidity and mortality rates were 16 and 0.7 %, respectively. CONCLUSIONS: This largest, multicenter, prospective study demonstrates the feasibility of SEMS placement as a BTS for malignant colorectal obstruction. SEMS serves as a safe and effective BTS with acceptable stoma creation and complication rates in patients with acute malignant colonic obstruction.

A Japanese prospective multicenter study of self-expandable metal stent placement for malignant colorectal obstruction: short-term safety and efficacy within 7 days of stent procedure in 513 cases.

BACKGROUND: Endoscopic self-expandable metal stent placement has been used as an alternative to surgery for malignant colorectal obstruction; however, factors affecting its clinical outcome are unclear. OBJECTIVE: To clarify the short-term safety and efficacy of endoscopic self-expandable metal stent placement for malignant colorectal obstruction and to identify factors associated with its clinical and technical failure. DESIGN: Prospective clinical cohort study. SETTING: Fourteen academic centers and 32 community hospitals. PATIENTS: A total of 513 consecutive patients with malignant colorectal obstruction. INTERVENTION: Endoscopic self-expandable metal stent placement, sharing of stent placement methods among participating facilities. MAIN OUTCOME MEASUREMENTS: The primary endpoint was clinical success, defined as symptom and radiological finding resolution within 24 hours. Secondary endpoints were technical success and adverse events. The follow-up period was 7 days. RESULTS: The clinical and technical success rates were 95.5% and 97.9%, respectively. Major adverse events included perforation (2.1%), stent migration (1.0%), and stent occlusion (0.8%). The main causes of perforation were the procedure itself (0.8%) and comorbidities (obstructive colitis and impending perforation) not apparent before stent placement (0.6%). Extrinsic tumor origin was independently associated with the clinical failure after stent placement (odds ratio 4.23; 95% confidence interval, 1.21-14.79; P = .02). Stricture marking trended toward a negative association with technical failure (P = .09). LIMITATIONS: Noncomparative study. CONCLUSION: Strict inclusion criteria and stricture marking may improve the technical and clinical success of stent placement.

Lymph node metastasis after endoscopic submucosal dissection of a differentiated gastric cancer confined to the mucosa with an ulcer smaller than 30 mm.

In the expanded indications for endoscopic resection, Japanese guidelines for gastric cancer include differentiated cancers confined to the mucosa with an ulcer <30 mm. We describe a patient with lymph node metastasis after curative endoscopic submucosal dissection (ESD) for a tumor of this indication. The patient was a 70-year-old man with chronic hepatitis C. He underwent ESD for early gastric cancer in May 2010. Pathology revealed a moderately differentiated adenocarcinoma, 22 × 17 mm in size, that was confined to the mucosa with an ulcer. The horizontal and vertical margins were negative for the tumor. We diagnosed thiscase as curative resection of expanded indication and followed this patient with endoscopy, abdominal ultrasonography (AUS) or enhanced computed tomography (CT) approximately every 6 months. After 17 months, lymph node metastasis was detected with AUS and CT and diagnosed by endoscopic ultrasound-guided fine-needle aspiration biopsy in August 2011. Distal gastrectomy with D2 dissection was carried out in December 2011. Although it is low, the possibility of recurrence should be borne in mind after endoscopic treatment of early gastric cancer, despite its inclusion in the expanded indications for endoscopic resection.

Endoscopic papillary large balloon dilation for removal of bile duct stones.

AIM: To investigate the efficacy and outcomes of endoscopic papillary large balloon dilation (EPLBD) for bile duct stones in a multicenter prospective study. METHODS: Lithotomy by EPLBD was conducted in 124 patients with bile duct stones ≥ 13 mm in size or with three or more bile duct stones ≥ 10 mm. After endoscopic sphincterotomy, the papilla was dilated using balloons 12-20 mm in diameter fitting the bile duct diameter. RESULTS: The success rate of first-time lithotomy was 86.3% (107/124) and the final lithotomy success rate was 100% (124/124). Lithotripsy was needed in 10 of the 124 (13.6%) patients. Adverse events due to the treatment procedure occurred in 6 (4.8%) patients, all of which were mild. Performing large balloon dilation after endoscopic sphincterotomy in patients with large stones or multiple stones in the bile duct is considered to ensure the safety of treatment and to reduce the need for lithotripsy. CONCLUSION: It is suggested that treatment by EPLBD for large bile duct stones may be safe and useful.

Gastrointestinal stromal tumor of the ampulla of Vater: a case report.

Gastrointestinal stromal tumors (GISTs) usually develop in the stomach and small intestine and only rarely occur at the ampulla of Vater, with only 11 cases reported in the literature. We report a case of a GIST of the ampulla of Vater. A 36-year-old, previously healthy man presented with a loss of consciousness lasting a few minutes. A gastroduodenal endoscopy revealed a submucosal tumor with central ulceration at the ampulla of Vater. The enhanced computed tomography scan revealed a smooth-outlined hypervascular solid mass (24 mm × 30 mm) in the second part of the duodenum. Neither lymphadenopathy nor metastasis was observed. Magnetic resonance cholangiopancreatography and endoscopic retrograde cholangiopancreatography showed normal bile and pancreatic ducts. Biopsies were collected from the ulcerative lesion, and the tumor was diagnosed as a GIST. A submucosal tumor with central ulceration may be a characteristic form of GISTs of the ampulla of Vater, and biopsy studies are useful for the diagnosing such tumors. The patient underwent pancreatoduodenectomy, and the operative specimen revealed a 2.2-cm GIST with 1 mitosis per 50 high-power fields. The gold standard for treatment of GISTs is surgical resection without rupture of a capsule. If technically possible, local resection may be considered. However, when the location of the lesion presents challenges, a pancreatoduodenectomy should be performed for GIST of the ampulla of Vater.