Background/Aims: A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC. Methods: In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events. Results: The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated. Conclusions HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).

Background/Aims: A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC. Methods: In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events. Results: The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated. Conclusions HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).

Background/Aims: A clinical unmet need persists for medications capable of modulating the progression of primary sclerosing cholangitis (PSC). This study aimed to assess the clinical feasibility of HK-660S (beta-lapachone) in PSC. Methods: In this multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 2 trial, participants were assigned in a 2:1 ratio to receive either 100 mg of HK-660S or a placebo twice daily for 12 weeks. The primary outcomes were the reduction in serum alkaline phosphatase (ALP) levels and the percentage of participants showing improvements in PSC severity, as determined by magnetic resonance cholangiopancreatography with the Anali score. Secondary endpoints included changes in liver stiffness and adverse events. Results: The analysis included 21 patients, 15 receiving HK-660S, and six receiving a placebo. Improvements in the Anali score were observed in 13.3% of the HK-660S group, with no improvements in the placebo group. HK-660S treatment resulted in a 15.2% reduction in mean ALP levels, compared to a 6.6% reduction in the placebo group. A stratified ad-hoc analysis based on baseline ALP levels showed a statistically significant response in the HK-660S group among those with ALP levels greater than twice the upper limit of normal, with a 50% responder rate (p=0.05). Additionally, 26.7% of the HK-660S group showed improvements in the enhanced liver fibrosis score, with no improvements in the placebo group. HK-660S was generally well tolerated. Conclusions HK-660S is well tolerated among patients with PSC and may improve bile duct strictures, decrease serum ALP levels, and reduce liver fibrosis (cris.nih.go.kr, Number KCT0006590).

The apprenticeship-based training method (ABTM) is highly effective for gastrointestinal (GI) endoscopic training. However, the conventional ABTM has significant issues. Although many supplementary training methods (TMs) have been developed and utilized, they cannot entirely replace the ABTM, which remains the major TM strategy. Currently, new TM construction is crucial and necessary due to financial constraints, difficulty of obtaining sufficient training time due to patient safety-related regulations, and catastrophic damage caused by disasters such as the coronavirus disease 2019 pandemic. The simulator-based TM (SBTM) is widely accepted as an alternative to the ABTM, owing to the SBTM’s advantages. Since the 1960s, many GI endoscopy training simulators have been developed and numerous studies have been published on their effectiveness. While previous studies have focused on the simulator’s validity, this review focused on the accessibility of simulators that were introduced by the end of 2021. Although the current SBTM is effective in GI endoscopic education, extensive improvements are needed to replace the ABTM. Incorporating simulator-incorporated TMs into an improved ABTM is an attempt to overcome the incompleteness of the current SBTM. Until a new simulator is developed to replace the ABTM, it is desirable to operate a simulator-integrated and well-coordinated TM that is suitable for each country and institution.

Common bile duct (CBD) stones are prevalent in 11% to 21% of patients with gallstones and can cause various clinical manifestations, from biliary colic to biliary sepsis. The treatment of choice is endoscopic retrograde cholangiopancreatography, but approximately 5% to 10% of CBD stones are difficult to remove using these conventional endoscopic methods. Although percutaneous transhepatic cholangioscopy and lithotripsy can be used as an alternative, it can be technically demanding and risky if the intrahepatic duct is not dilated. We report a case of a large CBD stone that was successfully removed using percutaneous transcholecystic cholangioscopy.

Objective: The coronavirus disease 2019 (COVID-19) pandemic has not yet been controlled and herd immunity through vaccination against COVID-19 has been considered the best option to prevent the spread of COVID-19 worldwide. We encountered several patients in our emergency department presenting with adverse reactions after COVID-19 vaccinations. Hence, we investigated the clinical characteristics of patients with adverse reactions after vaccination. Methods: In South Korea, 10,510 doses of the BNT162b2 mRNA COVID-19 vaccine was administered to 5,304 medical staff. To investigate adverse reactions, we reviewed the case report forms from the vaccination centers and the medical charts from the date of first dose administration until two weeks after the last planned second dose. Results: A total of 187 cases, out of the 10,510, experienced adverse reactions and these were more common in females. Dizziness (44.4%), nausea and vomiting (28.3%), and fever (24.1%) were the most reported adverse reactions. Immediate adverse reactions included dizziness, nausea, and vomiting, palpitation, sensory changes, and delayed adverse reactions included fever, myalgia, headache, nausea, and vomiting. The delayed reactions of fever and myalgia were significantly more common after the second, rather than after the first dose (P<0.01 and P=0.03, respectively). One case of anaphylaxis was reported. All adverse reactions improved after conservative care. Conclusion Our findings show diverse adverse reactions to the BNT162b2 mRNA COVID-19 vaccine, but none of them required hospitalization. However, since this vaccine has been manufactured using a newly developed technique, more research focused on the clinical significance of the adverse reactions is necessary.

Surgeries performed for patients with coronavirus disease 2019 (COVID-19) place the medical staff at very high risk of infection. We suggest recommendations for appropriate operation preparation, anesthetic management, and infection control for COVID-19 patients in operating rooms.Current Concepts: Surgeries must be performed in an airborne infection isolation room, such as a negative-pressure operating room. It is recommended that scheduled surgeries for COVID-19 patients be postponed to an acceptable extent, with the exception of emergency cases. Moreover, the number of medical staff participating in the surgery should be minimized. Medical staffs should practice proper hand hygiene and wear an appropriate level of personal protective equipment depending on the infection risk. While performing surgery and inducing anesthesia in COVID-19 patients, endotracheal intubation should be performed by trained anesthesiologists with a video laryngoscope, preferably using high-efficiency viral filters, which can prevent contamination in the anesthesia machine. Use of disposable equipment or COVID-19 patient-specific devices is recommended to prevent the spread of infection, but instruments that require sharing among multiple patients must be thoroughly cleaned and disinfected before their use for the next patient.Discussion and Conclusion: Medical staff performing surgeries for COVID-19 patients are at very high risk of infection. Therefore, the use of appropriate personal protective equipment, high-efficiency viral filters in breathing circuits during anesthesia, and disinfection of contaminated equipment after the operation are mandatory.

Surgeries performed for patients with coronavirus disease 2019 (COVID-19) place the medical staff at very high risk of infection. We suggest recommendations for appropriate operation preparation, anesthetic management, and infection control for COVID-19 patients in operating rooms.Current Concepts: Surgeries must be performed in an airborne infection isolation room, such as a negative-pressure operating room. It is recommended that scheduled surgeries for COVID-19 patients be postponed to an acceptable extent, with the exception of emergency cases. Moreover, the number of medical staff participating in the surgery should be minimized. Medical staffs should practice proper hand hygiene and wear an appropriate level of personal protective equipment depending on the infection risk. While performing surgery and inducing anesthesia in COVID-19 patients, endotracheal intubation should be performed by trained anesthesiologists with a video laryngoscope, preferably using high-efficiency viral filters, which can prevent contamination in the anesthesia machine. Use of disposable equipment or COVID-19 patient-specific devices is recommended to prevent the spread of infection, but instruments that require sharing among multiple patients must be thoroughly cleaned and disinfected before their use for the next patient.Discussion and Conclusion: Medical staff performing surgeries for COVID-19 patients are at very high risk of infection. Therefore, the use of appropriate personal protective equipment, high-efficiency viral filters in breathing circuits during anesthesia, and disinfection of contaminated equipment after the operation are mandatory.

Background: The analgesic effect of perineural opioid in clinical practice are still controversial. This randomized controlled trial compared analgesic effect of ropivacaine with fentanyl or ropivacaine alone for continuous femoral nerve block following unilateral total knee arthroplasty. Methods: Fourty patients of ASA PS Ⅰ or Ⅱ receiving total knee arthroplasty with spinal anesthesia were enlisted and randomly allocated into two groups. Group R; bolus injection of 0.375% ropivacaine, 30 ml and an infusion of 0.2% ropivacaine at 8 ml/h (n = 20). Group RF; 0.375% ropivacaine, 29 ml added with 50 μg of fentanyl as a bolus and an infusion of 0.2% ropivacaine mixed with 1 μg/ml of fentanyl at 8 ml/h (n = 20). Local anesthetic infusion via a femoral nerve catheter was started at the end of operation and continued for 48 h. Intravenous patient-controlled analgesia with hydromorphone (0.15 mg/ml, 0-1-10) were used for adjuvant analgesics. Position of catheter tip and contrast distribution, visual analog scale of pain, hydromorphone consumption, side effects were recorded for 48 h after operation. Patient satisfaction for the pain control received were noted. Results: The pain visual analogue scale, incidences of side effects and satisfaction were not different between the two groups (P > 0.05), but the hydromorphone usage at 48 h after operation were lower in the Group RF than in the Group R (P = 0.047). Conclusions The analgesic effect of ropivacaine with fentanyl for continuous femoral nerve block after knee replacement arthroplasty was not superior to that of the ropivacaine alone.

Background: Surgeries in patients with coronavirus disease 2019 (COVID-19) put medical staff at a high risk of infection. We report the anesthetic management and infection control of a mechanically ventilated COVID-19 patient who underwent exploratory laparotomy for suspected duodenal ulcer perforation.Case: A 73-year-old man, mechanically ventilated for confirmed COVID-19, showed clinical and radiographic signs of a perforated duodenal ulcer, and he was transferred under sedation and intubation to a negative-pressure operating room. The operating and assistant staff wore personal protective equipment. High-efficiency particulate absorbing (HEPA) filters were inserted into the expiratory circuits of the anesthesia machine and portable ventilator. No participating staff contracted COVID-19, although the patient later died due to pneumonia. Conclusions This report can contribute to establishing clinical guidelines for the surgical management and operation room setting of COVID-19 patients.