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.

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.

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.

Pseudoaneurysm caused by a self-expandable metal stent: a report of three cases.

We present three cases of pseudoaneurysm caused by self-expandable metal stents that formed arteriobiliary fistulas and caused hemobilia. Diagnoses were made on the basis of dynamic computed tomography or angiography. One patient died because of bleeding and cholangitis, whereas the others were successfully treated by transarterial embolization.

Endoscopic retrograde cholangiopancreatography using a cap-assisted highly flexible colonoscope in patients with Roux-en-Y anastomosis.

In this retrospective study of 10 patients with Roux-en-Y anastomosis, endoscopic retrograde cholangiopancreatography (ERCP) using a cap-assisted thin highly flexible colonoscope was done for treatment of bile duct stones. In five patients, the papilla of Vater was successfully reached using the colonoscope alone. However, in the other five patients, combination with an overtube was needed to reach the papilla. In all cases, complete removal of bile duct stones was accomplished. Procedure-related adverse events occurred in two cases. In conclusion, use of a cap-assisted thin highly flexible colonoscope for ERCP was successful in patients with a Roux-en-Y anastomosis.

Can endoscopic sphincterotomy be performed safely in elderly patients aged 80 years or older with pancreatic and biliary diseases?

BACKGROUND/AIMS: The purpose of this study was to investigate whether endoscopic sphincterotomy (EST) can be usefully and safely performed in elderly patients aged 80 years or older. METHODOLOGY: The eligible patients with pancreatic and biliary diseases who required EST were divided into two groups depending on their age: under 80 (group A) and 80 or older (group B). Patient characteristics, EST success rate and incidence of the related complications were evaluated. RESULTS: Of the 720 patients who required EST, 522 patients were in group A and 198 in group B. Group B incidences of patient characteristics at baseline disease and anticoagulant/antiplatelet therapy were significantly higher than in group A (p<0.05). The EST success rates were 97.1% (507/522) in group A and 96.5% (191/198) in group B. The incidences of the related complications were 8.8% (46/522) in group A and 4% (8/198) in group B, respectively, again without significant difference. CONCLUSIONS: The EST success rate and the incidence of related complications were comparable between patients in groups A and B, indicating that EST can be safely performed even in the elderly aged 80 years or older.

Long-term outcome of the WallFlex partially covered stent for unresectable malignant biliary obstruction: a multicenter single-arm prospective study.

BACKGROUND/AIMS: Covered metallic stent was developed to prevent tumor ingrowth. However, procedural accidents due to its insertion often occur and migration after long-term insertion causes problems. The WallFlex partially covered stent (WF) with reduced axial force enables stenting along the bile duct. We examined the usefulness of WF placement in an unresectable malignant distal biliary obstruction. METHODOLOGY: We examined procedural accidents, stent obstruction rate, and patency period caused by WF insertion. RESULTS: Ninety-seven patients were analyzed; procedural accidents caused by WF insertion occurred in 8 patients (7.2%) composed of acute cholecystitis in 3 patients (3.2%), acute pancreatitis in 2 patients (2.1%), acute cholangitis in 1 patient (1%), and other in 1 patient (1%). The stent obstruction rate was 19.6% (19 patients), and obstruction cause includes sludge in 9 patients (9.3%), migration in 4 patients (4.1%), food impaction in 3 patients (3.1%), ingrowth in 1 patient (1%), overgrowth in 0 patients (0%), and unknown in 2 patients (2.1%). The mean stent patency period was 634.918 +/- 66.545 (7-946) days. CONCLUSIONS: WF has less procedural accidents when inserted into unresectable malignant biliary obstruction patients with reduced migration rate after a long period and low obstruction rate.

[A case of solitary liver tuberculosis diagnosed by TB-PCR and managed conservatively].

A 42-year-old woman was admitted to our hospital with weight loss and right upper quadrant abdominal pain. Though an 8cm mass in liver segment 5/8 was detected by abdominal imaging, we could not confirm the diagnosis because findings on physical examination, blood chemistry, and radiologic examination were nonspecific. No cancer or immunocompromising diseases were found. We performed a liver biopsy because we were suspicious of a cold abscess caused by tuberculosis. Purulent material acquired from the biopsy revealed positive TB-PCR results, which confirmed the diagnosis of solitary liver tuberculosis. She received anti-tuberculosis medications leading to hepatic tumor resolution. There are very few reports of solitary liver tuberculosis diagnosed without surgery, thus we report this case of a solitary tubercle diagnosed by TB-PCR.

Location in the ascending colon is a predictor of refractory colonic diverticular hemorrhage after endoscopic clipping.

BACKGROUND: Predictors of refractory colonic diverticular hemorrhage after endoscopic clipping (EC) remain unclear. OBJECTIVE: To elucidate the predictors of uncontrolled bleeding after EC. DESIGN: Retrospective study. SETTING: Two tertiary referral centers. PATIENTS: Eighty-nine patients with colonic diverticular hemorrhage who underwent EC as a first-line treatment were included. INTERVENTIONS: If bleeding remained uncontrolled after 1 or 2 EC sessions, other interventions (transcatheter arterial embolization, endoscopic band ligation, or surgery) were performed. Patients were divided into EC-controlled and EC-uncontrolled groups; the characteristics of each group were compared. MAIN OUTCOME MEASUREMENTS: Comorbidities, location of bleeding diverticula, and EC technique (direct vs indirect placement). RESULTS: Initial treatment with EC was successful in 87 patients. Early rebleeding (primary failure) occurred in 30 of 87 patients (34%). Secondary failure occurred in 6 of 22 patients treated with reclipping (27%). Cumulatively, 78 patients were successfully managed with EC. Non-EC treatments were required in 11 patients. Location in the right side of the colon, particularly in the ascending colon, was significantly more common in the EC-uncontrolled group than in the EC-controlled group (P = .017 and P = .0029, respectively). Although the difference was not significant, bleeding was successfully managed in all 13 patients treated with direct placement. Bleeding remained uncontrolled after EC in 11 of 52 ascending cases (21%) treated with indirect placement. Diverticular hemorrhage in other locations was managed regardless of EC technique. LIMITATIONS: Retrospective study. CONCLUSIONS: Location in the ascending colon is a significant predictor of refractory colonic diverticular hemorrhage after EC. Indirect placement of hemoclips in ascending lesions is ineffective.

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.

[Case of von Hippel-Lindau disease diagnosed by detection of multiple pancreatic endocrine tumors and renal tumor 13 years after bilateral adrenalectomy].

von Hippel-Lindau (VHL) syndrome is an inherited neoplastic syndrome caused by abnormity of the VHL gene found on the short arm of the chromosome 3. We reported a case of VHL disease diagnosed by the detection of multiple pancreatic endocrine tumors and renal tumor 13 years after bilateral adrenalectomy. A 40-year-old man presented with multiple pancreas tumors (maximum size 42 mm in diameter) detected by screening abdominal ultrasonography. A 23 mm renal tumor was detected by contrast computed tomography scan at that time. His past history included left retinal angioma (age 15) and bilateral adrenal pheochromocytoma (age 27). VHL was diagnosed by genetic testing. Endoscopic ultrasound-guided fine-needle aspiration biopsy of the pancreas tumor was performed, and tumor was diagnosed as an endocrine tumor. After diagnosis, distal pancreatectomy (body-tail) was performed. This was a didactic case indicating that we should suspect VHL syndrome based on past history and family history and follow such cases up strictly.

[A case of duodenal gangliocytic paraganglioma with lymph node metastasis].

A 28-year-old man complained of tarry stool. A series of examinations showed a submucosal tumor with bleeding at the papilla of Vater and a swollen # 17b lymph node, both of which indicated a hypervascular tumor. The pathological findings of the enucleated tumor specimens revealed gangliocytic paraganglioma with metastasis to the # 17b lymph node. Additional pancreaticoduodenectomy revealed another # 17b lymph node metastasis 7-mm in diameter. Although the majority of gangliocytic paragangliomas are benign, 7% of reported cases have lymph node metastases, as shown in the present case. These findings are important in treating patients with gangliocytic paraganglioma.

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.