Introduction: Calciphylaxis is a rare disorder characterized by painful ischemic skin ulcers. There is currently no approved therapy and its pain management is often challenging. Case: A 40-year-old female was diagnosed with calciphylaxis seven years after starting hemodialysis. Despite the administration of sodium thiosulfate intravenous and intralesional combination therapy, the ulcers progressed on both lower limbs and buttocks. She suffered from terrible and opioid refractory pain due to ulcers. After careful consideration of the appropriateness, a lumbar sympathetic ganglion block (LSGB) was performed. Six months later, all the ulcers had re-epithelialized and she was relieved of pain. Conclusion: While the appropriateness of LSGB must be carefully evaluated, it could be a treatment option for patients with central-type calciphylaxis.

Objective: To evaluate the real-world risk of hypocalcemia in Japanese patients with rheumatoid arthritis (RA) receiving disease-modifying antirheumatic drugs (DMARDs) newly initiated on denosumab (PRALIA®) versus those receiving DMARDs alone.Design: Observational cohort study utilizing data obtained from the Medical Information Database Network (MID-­NET®) in Japan.Methods: Patients were eligible if they had a prescription record for any DMARD during the study period (July 2016–­December 2020), with their RA diagnosis ＜30 days before the date of DMARD prescription. Primary and secondary outcomes included the incidence of hypocalcemia (serum calcium level ＜8.50 mg/dL), and severe hypocalcemia (serum calcium level ＜7.00 mg/dL), respectively. Data was classified according to denosumab-exposure versus non-exposure, with outcomes assessed during the follow-up period. Results: Overall, 4,222 patients (denosumab-exposed patients: N＝293; non-exposed patients: N＝3,929) met the study criteria. Hypocalcemia occurred in 4.8％（95％CI: 2.6-­7.9) of denosumab-exposed patients and 1.0％（95％CI: 0.7-­1.4) of non-exposed patients, for an adjusted risk ratio (RR) of 1.67（95％CI: 0.90-­3.10).Conclusion: The incidence of hypocalcemia was increased in denosumab-exposed patients compared with non-exposed patients with RA in this observational study utilizing data from MID-­NET®. As the adjusted RR of hypocalcemia with denosumab was modest, current risk management strategies outlined in the package insert are appropriate.

Objective: To evaluate the real-world risk of hypocalcemia in Japanese patients with rheumatoid arthritis (RA) receiving disease-modifying antirheumatic drugs (DMARDs) newly initiated on denosumab (PRALIA®) versus those receiving DMARDs alone.Design: Observational cohort study utilizing data obtained from the Medical Information Database Network (MID-NET®) in Japan.Methods: Patients were eligible if they had a prescription record for any DMARD during the study period (July 2016-December 2020), with their RA diagnosis ＜30 days before the date of DMARD prescription. Primary and secondary outcomes included the incidence of hypocalcemia (serum calcium level ＜8.50 mg/dL), and severe hypocalcemia (serum calcium level ＜7.00 mg/dL), respectively. Data was classified according to denosumab-exposure versus non-exposure, with outcomes assessed during the follow-up period. Results: Overall, 4,222 patients (denosumab-exposed patients: N＝293; non-exposed patients: N＝3,929) met the study criteria. Hypocalcemia occurred in 4.8％（95％CI: 2.6-­7.9) of denosumab-exposed patients and 1.0％（95％CI: 0.7-­1.4) of non-exposed patients, for an adjusted risk ratio (RR) of 1.67（95％CI: 0.90-­3.10).Conclusion: The incidence of hypocalcemia was increased in denosumab-exposed patients compared with non-exposed patients with RA in this observational study utilizing data from MID-­NET®. As the adjusted RR of hypocalcemia with denosumab was modest, current risk management strategies outlined in the package insert are appropriate.

Background/Aims: The anastomotic site after distal gastrectomy is the area most affected by duodenogastric reflux. Different reconstruction methods may affect the lesion characteristics and treatment outcomes of remnant gastric cancers at the anastomotic site. We retrospectively investigated the clinicopathologic and endoscopic submucosal dissection outcomes of remnant gastric cancers at the anastomotic site. Methods: We recruited 34 consecutive patients who underwent endoscopic submucosal dissection for remnant gastric cancer at the anastomotic site after distal gastrectomy. Clinicopathology and treatment outcomes were compared between the Billroth II and non-Billroth II groups. Results: The tumor size in the Billroth II group was significantly larger than that in the non-Billroth II group (22 vs. 19 mm; p=0.048). More severe gastritis was detected endoscopically in the Billroth II group (2 vs. 1.33; p=0.0075). Moreover, operation time was longer (238 vs. 121 min; p=0.004) and the frequency of bleeding episodes was higher (7.5 vs. 3.1; p=0.014) in the Billroth II group. Conclusions Compared to remnant gastric cancers in non-Billroth II patients, those in the Billroth II group had larger lesions with a background of severe remnant gastritis. Endoscopic submucosal dissection for remnant gastric cancers in Billroth II patients involved longer operative times and more frequent bleeding episodes than that in patients without Billroth II.

BACKGROUND/AIMS: Although the risk of bleeding after endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is low, the safety of EUS-FNA in patients prescribed antithrom-botic agents is unclear. Therefore, this study evaluated the incidence of bleeding after EUS-FNA in those patients. METHODS: Between September 2012 and September 2015, patients who were prescribed antithrombotic agents underwent EUS-FNA at 13 institutions in Japan were prospectively enrolled in the study. The antithrombotic agents were managed according to the guidelines of the Japanese Gastrointestinal Endoscopy Society. The rate of bleeding events, thromboembolic events and other complications within 2 weeks after EUS-FNA were analyzed. RESULTS: Of the 2,629 patients who underwent EUS-FNA during the study period, 85 (62 males; median age, 74 years) patients were included in this stduy. Two patients (2.4%; 95% confidence interval [CI], 0.6% to 8.3%) experienced bleeding events. One patient required surgical intervention for hemothorax 5 hours after EUS-FNA, and the other experienced melena 8 days after EUS-FNA and required red blood cell transfusions. No thromboembolic events occurred (0%; 95% CI, 0.0% to 4.4%). Three patients (3.5%; 95% CI, 1.2% to 10.0%) experienced peri-puncture abscess formation. CONCLUSIONS: The rate of bleeding after EUS-FNA in patients prescribed antithrombotic agents might be considerable.
Abscess ; Asian Continental Ancestry Group ; Endoscopic Ultrasound-Guided Fine Needle Aspiration* ; Endoscopy, Gastrointestinal ; Erythrocyte Transfusion ; Fibrinolytic Agents* ; Hemorrhage* ; Hemothorax ; Humans ; Incidence ; Japan ; Male ; Melena ; Prospective Studies*

Background:Capecitabine and irinotecan combination therapy (XELIRI) has been examined at various dose levels to treat metastatic colorectal cancer (mCRC). Recently, in the Association of Medical Oncology of the German Cancer Society (AIO) 0604 trial, tri?weekly XELIRI plus bevacizumab, with reduced doses of irinotecan (200mg/m2 on day 1) and capecitabine (1600mg/m2 on days 1–14), repeated every 3weeks, has shown favorable tolerability and effcacy which were comparable to those of capecitabine and oxaliplatin (XELOX) plus bevacizumab. The doses of capecit?abine and irinotecan in the AIO trial are considered optimal. In a phase I/II study, XELIRI plus bevacizumab (BIX) as second?line chemotherapy was well tolerated and had promising effcacy in Japanese patients. Methods:The Asian XELIRI ProjecT (AXEPT) is an East Asian collaborative, open?labelled, randomized, phase III clinical trial which was designed to demonstrate the non?inferiority of XELIRI with or without bevacizumab versus standard FOLFIRI (5?lfuorouracil, leucovorin, and irinotecan combination) with or without bevacizumab as second?line chemo?therapy for patients with mCRC. Patients with 20years of age or older, histologically conifrmed mCRC, Eastern Coop?erative Oncology Group performance status 0–2, adequate organ function, and disease progression or intolerance of the ifrst?line regimen will be eligible. Patients will be randomized (1:1) to receive standard FOLFIRI with or with?out bevacizumab (5mg/kg on day 1), repeated every 2weeks (FOLIRI arm) or XELIRI with or without bevacizumab (7.5mg/kg on day 1), repeated every 3weeks (XELIRI arm). A total of 464 events were estimated as necessary to show non?inferiority with a power of 80% at a one?sided α of 0.025, requiring a target sample size of 600 patients. The 95% conifdence interval (CI) upper limit of the hazard ratio was pre?speciifed as less than 1.3. Conclusion:The Asian XELIRI ProjecT is a multinational phase III trial being conducted to provide evidence for XELIRI with or without bevacizumab as a second?line treatment option of mCRC.

STUDY DESIGN: Retrospective study. PURPOSE: To assess treatment outcomes of snowboarding-related spinal and spinal cord injuries. OVERVIEW OF LITERATURE: Snowboarding-related spinal or spinal cord injury have a great impact on social and sporting activities. METHODS: A retrospective review of 19 cases of surgically treated snowboard-related injury was done. Analyzed parameters included site of injury, type of fracture, peri- and postoperative complications, pre- and postoperative neurological status, activities of daily living, and participation in sports activities at the final follow-up. RESULTS: The major site of injury was the thoracolumbar junction caused by fracture-dislocation (13/19 cases). The remaining 6 cases had cervical spine injuries. Over 60% of the patients had Frankel A and B paralysis. All patients were surgically treated by posterior fusion with instrumentation. Five underwent additional anterior fusion. Surgical outcome was restoration of ambulatory capacity in 12 patients (63.2%). Ultimately, 15 patients (78.9%) could return to work. Patients with complete paralysis upon admission showed reduced ambulatory capacity compared to those with incomplete paralysis. None of the patients again participated in any sports activities, including snowboarding. CONCLUSIONS: Snowboarding-related spinal or spinal cord injury has a great impact on social as well as sports activities. It is necessary to enhance promotion of injury prevention emphasizing the snowboarders' responsibility code.
Activities of Daily Living ; Follow-Up Studies ; Humans ; Paralysis ; Postoperative Complications ; Retrospective Studies ; Return to Work ; Skiing* ; Spinal Cord Injuries ; Spinal Injuries* ; Spine ; Sports

STUDY DESIGN: Animal study. PURPOSE: To review the present warning point criteria of the compound muscle action potential (CMAP) and investigate new criteria for spinal surgery safety using an animal model. OVERVIEW OF LITERATURE: Little is known about correlation palesis and amplitude of spinal cord monitoring. METHODS: After laminectomy of the tenth thoracic spinal lamina, 2-140 g force was delivered to the spinal cord with a tension gage to create a bilateral contusion injury. The study morphology change of the CMAP wave and locomotor scale were evaluated for one month. RESULTS: Four different types of wave morphology changes were observed: no change, amplitude decrease only, morphology change only, and amplitude and morphology change. Amplitude and morphology changed simultaneously and significantly as the injury force increased (p<0.05) Locomotor scale in the amplitude and morphology group worsened more than the other groups. CONCLUSIONS: Amplitude and morphology change of the CMAP wave exists and could be the key of the alarm point in CMAP.
Action Potentials* ; Animals* ; Contusions ; Gravitation ; Laminectomy ; Models, Animal* ; Spinal Cord

BACKGROUND/AIMS: Several studies have shown the usefulness of endoscopic nasogallbladder drainage (ENGBD) in patients with acute cholecystitis. However, the procedure is difficult, and factors that affect technical success have not yet been clarified. We conducted a prospective study to evaluate the technical feasibility, efficacy, and predictive factors for the technical success of ENGBD in patients with acute cholecystitis. METHODS: All patients with moderate or severe acute cholecystitis who were enrolled underwent ENGBD between April 2009 and April 2011. Patients with surgically altered anatomy or pancreatobiliary malignancies were excluded. The primary outcomes included technical success, clinical success, and complications. Factors that could affect the technical success were also examined. RESULTS: Of the 27 patients who underwent ENGBD during the study period, technical success was achieved in 21 (78%) and clinical improvement was achieved in 20 (95%). Early complications were encountered in four patients (15%). Gallbladder wall thickness (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.08 to 2.47) and age (OR, 1.16; 95% CI, 1.00 to 1.35) were effective predictors of technical failure. CONCLUSIONS: ENGBD was effective in resolving acute cholecystitis; however, this modality was technically challenging and had a limited success rate. Because of technical difficulties, ENGBD should be reserved for limited indications.
Age Factors ; Aged ; Aged, 80 and over ; Cholecystitis, Acute/*surgery ; Drainage/*methods ; Endoscopy, Gastrointestinal/*methods ; Feasibility Studies ; Female ; Gallbladder/pathology/*surgery ; Humans ; Male ; Middle Aged ; Odds Ratio ; Postoperative Complications/epidemiology ; Prospective Studies ; Sphincterotomy, Endoscopic ; Treatment Outcome

BACKGROUND/AIMS: Several studies have shown the usefulness of endoscopic nasogallbladder drainage (ENGBD) in patients with acute cholecystitis. However, the procedure is difficult, and factors that affect technical success have not yet been clarified. We conducted a prospective study to evaluate the technical feasibility, efficacy, and predictive factors for the technical success of ENGBD in patients with acute cholecystitis. METHODS: All patients with moderate or severe acute cholecystitis who were enrolled underwent ENGBD between April 2009 and April 2011. Patients with surgically altered anatomy or pancreatobiliary malignancies were excluded. The primary outcomes included technical success, clinical success, and complications. Factors that could affect the technical success were also examined. RESULTS: Of the 27 patients who underwent ENGBD during the study period, technical success was achieved in 21 (78%) and clinical improvement was achieved in 20 (95%). Early complications were encountered in four patients (15%). Gallbladder wall thickness (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.08 to 2.47) and age (OR, 1.16; 95% CI, 1.00 to 1.35) were effective predictors of technical failure. CONCLUSIONS: ENGBD was effective in resolving acute cholecystitis; however, this modality was technically challenging and had a limited success rate. Because of technical difficulties, ENGBD should be reserved for limited indications.
Age Factors ; Aged ; Aged, 80 and over ; Cholecystitis, Acute/*surgery ; Drainage/*methods ; Endoscopy, Gastrointestinal/*methods ; Feasibility Studies ; Female ; Gallbladder/pathology/*surgery ; Humans ; Male ; Middle Aged ; Odds Ratio ; Postoperative Complications/epidemiology ; Prospective Studies ; Sphincterotomy, Endoscopic ; Treatment Outcome