Endoscopic ultrasound-guided biliary drainage (EUS-BD), EUS-guided choledochoduodenostomy (EUS-CDS), and EUS-guided hepaticogastrostomy (EUS-HGS) can effectively palliate obstructive jaundice, but have not been well established yet. The incidence of complications is about 30% in EUSBD and higher for EUS-HGS. Several complications have been reported such as bleeding, perforation and peritonitis. Bleeding occurs due to puncture of portal vein, hepatic vein and artery, and we should use color Doppler. When a cautery dilator is used for fistula dilation, burn effects may cause delayed bleeding. Endoscopic hemostasis is only effective for anastomotic bleeding and embolization with interventional radiology technique is required for pseudo aneurysm. There are some types of perforation: failed stent placement after puncture or fistula dilation, double puncture during CDS procedure, and stent migration. Peritonitis with perforation requires surgery and can be fatal. Stent migration before mature fistula formation causes severe peritonitis because EUS-BD makes fistula between two unattached organs. Stents with flaps or long covered self-expandable metallic stents (cSEMSs) are effective to prevent migration. Recent development of lumen apposing stents may reduce early migration in EUS-CDS. Peritonitis without migration can be due to 1) leakage of bile juice or gastric/duodenal contents during EUS-BD or 2) leakage along the placed stent. We should make procedure time as short as possible, and cSEMSs reduce bile leak along the stent by occluding the dilated fistula. In summary, we should understand the mechanism of complications and the technique to prevent and manage complications. Development of dedicated devices to increase the success rate and reduce complications is required.
Aneurysm ; Arteries ; Bile ; Burns ; Cautery ; Choledochostomy ; Drainage* ; Fistula ; Hemorrhage ; Hemostasis, Endoscopic ; Hepatic Veins ; Incidence ; Jaundice, Obstructive ; Peritonitis ; Portal Vein ; Punctures ; Radiology, Interventional ; Stents

BACKGROUND/AIMS: In distal malignant biliary obstruction, an antireflux metal stent (ARMS) with a funnel-shaped valve is effective as a reintervention for metal stent occlusion caused by reflux. This study sought to evaluate the feasibility of this ARMS as a first-line metal stent. METHODS: Patients with nonresectable distal malignant biliary obstruction were identified between April and December 2014 at three Japanese tertiary centers. We retrospectively evaluated recurrent biliary obstruction and adverse events after ARMS placement. RESULTS: In total, 20 consecutive patients were included. The most common cause of biliary obstruction was pancreatic cancer (75%). Overall, recurrent biliary obstruction was observed in seven patients (35%), with a median time to recurrent biliary obstruction of 246 days (range, 11 to 246 days). Stent occlusion occurred in five patients (25%), the causes of which were sludge and food impaction in three and two patients, respectively. Stent migration occurred in two patients (10%). The rate of adverse events associated with ARMS was 25%: pancreatitis occurred in three patients, cholecystitis in one and liver abscess in one. No patients experienced non-occlusion cholangitis. CONCLUSIONS: The ARMS as a first-line biliary drainage procedure was feasible. Because the ARMS did not fully prevent stent dysfunction due to reflux, further investigation is warranted.
Arm ; Asian Continental Ancestry Group ; Cholangiopancreatography, Endoscopic Retrograde ; Cholangitis ; Cholecystitis ; Drainage ; Humans ; Liver Abscess ; Pancreatic Neoplasms ; Pancreatitis ; Pilot Projects* ; Retrospective Studies ; Sewage ; Stents*

BACKGROUND/AIMS: Endoscopic placement of self-expandable metal stents (SEMSs) has emerged as a palliative treatment for malignant gastric outlet obstruction (GOO). Although covered SEMSs can prevent tumor ingrowth, frequent migration of covered SEMSs may offset their advantages in preventing tumor ingrowth. METHODS: We conducted this multicenter, single-arm, retrospective study at six tertiary referral centers to evaluate the safety and efficacy of a partially covered SEMS with an uncovered large-bore flare at the proximal end as an antimigration system in 41 patients with symptomatic malignant GOO. The primary outcome was clinical success, and the secondary outcomes were technical success, stent dysfunction, adverse events, and survival after stent placement. RESULTS: The technical and clinical success rates were 100% and 95%, respectively. Stent dysfunctions occurred in 17 patients (41%), including stent migration in nine (23%), tumor ingrowth in one (2%), and tumor overgrowth in four (10%). Two patients (5%) developed adverse events: one pancreatitis and one perforation. No procedure-related death was observed. CONCLUSIONS: A novel partially covered SEMS with a large-bore flare proximal end was safe and effective for malignant GOO but failed to prevent stent migration. Further research is warranted to develop a covered SEMS with an optimal antimigration system.
Gastric Outlet Obstruction* ; Humans ; Palliative Care ; Pancreatitis ; Retrospective Studies ; Self Expandable Metallic Stents ; Stents* ; Tertiary Care Centers

RevMate®is one of risk minimization activities in Japanese RMPs of Revlimd®and Pomalyst®, of which indications are hematological malignancy including multiple myeloma. This is a proper management procedure approved by Japanese health authorities in order to prevent exposure to pregnant women because these agents are derivatives of thalidomide. RevMate® was revised in 2015 after the discussion in MHLW's Taskforce and its operation started from April 2016. Due to this revision of version 5.0, the manufacture no longer receives the patient name, and this and other information must be managed by the hospital. In addition, with regard to the same objective in the format used in the management procedure（TERMS®）of thalidomide drug products, unification was attempted concerning the name of the format andthe notation of confirmation items. Physician becomes to make judgment to omit explanation of some RevMate® requirements based on the patient's level of their understandings to RevMate®. Periodical survey sheet regarding compliance with RevMate® requirement filled by a patient is to be submitted directly to a physician on his/her visit instead of sending it to the manufacturer by mail under previous procedures. A representative person of the manufacture is required to visit the hospital periodically and confirm filing condition of the survey sheets and compliance check lists of RevMate® for every prescription as well appropriately at the hospital. Furthermore, RevMate® was revised to add clear role description of relevant pharmacists and nurses for in-patients and its strict drug-handling procedures at bedside as version 5.1, as we received four reports from hospitals of medication error of our drug to the another patient in the hospital within 2016. After getting approval of additional indications for Revlimid® from March 2017, RevMate® of version 5.2 started. In the view of implement RevMate® as strict “risk minimization activities” to prevent pregnant women from exposure, we will continue to solve each problem recognized from the actual operation, constantly keep basics in mind by providing necessary training to our employees about thalidomide drug problem etc. In addition, we appreciate the understanding and support from the patient, patient family, Healthcare Professional, etc. involved in this procedure without incompleteness as well as non-compliance with procedures caused by habituation. Including all these, we consider it is important to endeavor as a manufacture continuously in the future.

Endoscopic ultrasound (EUS)-guided intervention has been established as a safe, effective and minimally invasive procedure for various diseases in adults, but there have been limited reports in pediatric patients. Herein, we report our experience with successful EUS-guided drainage of an intra-abdominal abscess in a 1-year-old infant concomitant with disseminated intravascular coagulation. The abscess was punctured via the stomach using a standard, convex-type echoendoscope, and the patient's condition improved after naso-cystic catheter placement. Although the clinical course was complicated by delayed hemorrhage from the puncture site, the bleeding was successfully managed by endoscopic hemostasis using a standard forward-viewing endoscope.
Abdominal Abscess* ; Abscess ; Adult ; Catheters ; Disseminated Intravascular Coagulation ; Drainage* ; Endoscopes ; Hemorrhage ; Hemostasis, Endoscopic ; Humans ; Infant* ; Punctures ; Stomach ; Ultrasonography

Mengen is an acute symptom that sometimes occurs after administration of a Kampo formula. It is a shortterm phenomenon and its onset indicates that the patient's clinical course will improve rapidly. It is important to distinguish it from other adverse events, which are not temporary. However, to date, detailed analysis of mengen characteristics such as its frequency, time of onset after Kampo administration, and duration have not been reported. Therefore, we report a precise analysis of mengen characteristics through a literature review of case reports published between 1945 and 2009 in Japan, and retrospective analyses of the cases in our institute.
The literature review revealed that 42% patients developed symptoms of mengen within a day of administration, and 79% developed symptoms within 3 days. In terms of mengen duration, the symptoms persisted for 1 day in 35% cases and 3 days in 63% cases. A diagnosis of mengen proved difficult in 39% cases that presented with atypical symptoms.
Overall, the retrospective analysis of the cases in our institute revealed that 11 patients (7.7%) developed mengen, among 143 patients treated with Kampo between May 2010 and November 2011.