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1.
Yonsei Medical Journal ; : 291-296, 2023.
Article in English | WPRIM | ID: wpr-977425

ABSTRACT

Purpose@#Ear reconstruction is one of the most difficult areas in the field of reconstructive surgery. Due to limitations of the current practice, a novel method of auricular reconstruction is needed. Major advancements in three-dimensional (3D) printing technique have rendered the process of ear reconstruction more favorable. Herein, we present our experience in designing and clinically using 3D implants in both 1st and 2nd stage ear reconstruction surgery. @*Materials and Methods@#After obtaining 3D CT data from each patient, a 3D geometric ear model was created using mirroring and segmentation processes. The 3D-printed implant design resembles but does not exactly match the normal ear shape, and can be inserted in harmony with the currently used surgical technique. The 2nd stage implant was designed to minimize dead space and support the posterior ear helix. The 3D implants were finally fabricated with a 3D printing system and used in ear reconstruction surgery in our institute. @*Results@#The 3D implants were manufactured for application to the currently used two-stage technique while maintaining the shape of the patient’s normal ear. The implants were successfully used for ear reconstruction surgery in microtia patients. A few months later, the 2nd stage implant was used in the 2nd stage operation. @*Conclusion@#The authors were able to design, fabricate, and apply patient-specific 3D-printed ear implants for 1st and 2nd stage ear reconstruction surgeries. This design, combined with 3D bioprinting technique, may be a future alternative for ear reconstruction.

2.
Tissue Engineering and Regenerative Medicine ; (6): 69-81, 2023.
Article in English | WPRIM | ID: wpr-968795

ABSTRACT

BACKGROUND@#Bone growth factors, particularly bone morphogenic protein-2 (BMP-2), are required for effective treatment of significant bone loss. Despite the extensive development of bone substitutes, much remains to be desired for wider application in clinical settings. The currently available bone substitutes cannot sustain prolonged BMP-2 release and are inconvenient to use. In this study, we developed a ready-to-use bone substitute by sequential conjugation of BMP to a three-dimensional (3D) poly(L-lactide) (PLLA) scaffold using novel molecular adhesive materials that reduced the operation time and sustained prolonged BMP release. @*METHODS@#A 3D PLLA scaffold was printed and BMP-2 was conjugated with alginate-catechol and collagen. PLLA scaffolds were conjugated with different concentrations of BMP-2 and evaluated for bone regeneration in vitro and in vivo using a mouse calvarial model. The BMP-2 release kinetics were analyzed using ELISA. Histological analysis and microCT image analysis were performed to evaluate new bone formation. @*RESULTS@#The 3D structure of the PLLA scaffold had a pore size of 400 lm and grid thickness of 187–230 lm. BMP-2 was released in an initial burst, followed by a sustained release for 14 days. Released BMP-2 maintained osteoinductivity in vitro and in vivo. Micro-computed tomography and histological findings demonstrate that the PLLA scaffold conjugated with 2 lg/ml of BMP-2 induced optimal bone regeneration. @*CONCLUSION@#The 3D-printed PLLA scaffold conjugated with BMP-2 enhanced bone regeneration, demonstrating its potential as a novel bone substitute.

3.
The Korean Journal of Internal Medicine ; : 167-175, 2023.
Article in English | WPRIM | ID: wpr-968755

ABSTRACT

Background/Aims@#Little is known about the effect of Helicobacter pylori eradication on the recurrence of gastric hyperplastic polyps after endoscopic resection. Thus, we evaluated the recurrence rate of gastric hyperplastic polyps based on H. pylori eradication following endoscopic resection. @*Methods@#We retrospectively reviewed the medical records of 201 patients with H. pylori infection who underwent endoscopic resection for gastric hyperplastic polyps at six medical centers. H. pylori status was assessed by histological analysis and a rapid urease test. A total of 149 patients underwent successful H. pylori eradication (eradication group), whereas 52 patients had persistent H. pylori infections (non-eradication group). The recurrence rate of gastric hyperplastic polyps and the risk factors according to H. pylori status were analyzed. @*Results@#During the mean follow-up period of 18.3 months, recurrent gastric polyps developed after endoscopic resection in 10 patients (19.2% [10/52]) in the non-eradication group and 12 patients (8.1% [12/149]) in the eradication group. The cumulative incidence of recurrent gastric hyperplastic polyps was significantly higher in the non-eradication group than in the eradication group (p = 0.041, log‐rank test). In the adjusted analysis, H. pylori eradication reduced the recurrence of gastric hyperplastic polyps (hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.18 to 0.99), whereas anticoagulation therapy increased the risk of recurrence of gastric hyperplastic polyps (HR, 4.91; 95% CI, 1.39 to 17.28). @*Conclusions@#Successful eradication of H. pylori may reduce the recurrence of gastric hyperplastic polyps in patients after endoscopic mucosal resection.

4.
Korean Journal of Pancreas and Biliary Tract ; : 126-130, 2023.
Article in Korean | WPRIM | ID: wpr-1002382

ABSTRACT

Acute pancreatitis caused by eosinophilic gastroenteritis is a rare disease, and little has been reported so far. Diagnosing eosinophilic gastroenteritis is difficult because the symptoms and laboratory findings are not specific. We report a rare case of eosinophilic gastroenteritis related to acute pancreatitis as a possible cause of idiopathic acute pancreatitis. A 61-year-old man visited the hospital complaining of epigastric pain. Although no pancreatic abnormalities were confirmed on imaging studies, the patient showed hyperamylasemia and hyperlipasemia. Serum eosinophil fractions were initially normal. However, they were elevated on follow-up examinations, and a large number of eosinophils were observed in the biopsies of the stomach and duodenum, which led to the diagnosis of eosinophilic gastroduodenitis related to acute pancreatitis.

5.
The Journal of the Korean Orthopaedic Association ; : 260-264, 2022.
Article in English | WPRIM | ID: wpr-938328

ABSTRACT

“Locked-lateral” calcaneal fracture-dislocations are very rare. This paper reviewed the helpful radiographic and diagnostic characteristics.A 52-year-old male was treated with reduction and fixation using the sinus tarsi approach. The author reports this case with a review of the related literature.

6.
Journal of Korean Diabetes ; : 225-237, 2021.
Article in Korean | WPRIM | ID: wpr-918905

ABSTRACT

The accuracy and convenience of continuous glucose monitoring (CGM), which efficiently evaluates glycemic variability and hypoglycemia, are improving. There are two types of CGM: professional CGM and personal CGM. Personal CGM is subdivided into real-time CGM (rt-CGM) and intermittently scanned CGM (isCGM). CGM is being emphasized in both domestic and foreign diabetes management guidelines. Regardless of age or type of diabetes, CGM is useful for diabetic patients undergoing multiple insulin injection therapy or using an insulin pump. rt-CGM is recommended for all adults with type 1 diabetes (T1D), and can also be used in type 2 diabetes (T2D) treatments using multiple insulin injections. In some cases, short-term or intermittent use of CGM may be helpful for patients with T2D who use insulin therapy other than multiple insulin injections and/or oral hypoglycemic agents. CGM can help to achieve A1C targets in diabetes patients during pregnancy. CGM is a safe and cost-effective alternative to self-monitoring blood glucose in T1D and some T2D patients. CGM used in diabetes management works optimally with proper education, training, and follow up. To achieve the activation of CGM and its associated benefits, it is necessary to secure sufficient repetitive training and time for data analysis, management, and education. Various supports such as compensation, insurance coverage expansion, and reimbursement are required to increase the effectiveness of CGM while considering the scale of benefit recipients, policy priorities, and financial requirements.

7.
Clinical Endoscopy ; : 563-569, 2021.
Article in English | WPRIM | ID: wpr-890034

ABSTRACT

Background/Aims@#Endoscopic resection (ER) has recently been accepted as the standard treatment modality for superficial nonampullary duodenal tumors (SNADTs). However, the procedure can cause adverse events such as perforation and bleeding. This study aimed to investigate the efficacy of prophylactic clipping in the prevention of delayed complications. @*Methods@#A retrospective review of the medical records of patients who underwent ER for SNADT from 3 centers was performed. Patients were divided into 2 groups: the immediate clipping group (ICG) and the no clipping group (NCG). Various baseline characteristics and factors associated with the appearance of delayed complications, such as size of the lesion, tumor location, histologic type, and co-morbidities, were compared between the two groups. @*Results@#A total of 99 lesions from 99 patients were included in this study. Fifty-two patients were allocated into ICG and 47 patients were allocated into NCG. Delayed bleeding occurred in 1 patient from ICG and in 8 patients from NCG. Delayed perforation occurred in 1 patient from ICG and in 3 patients from NCG. There were no procedure-related deaths in both groups. @*Conclusions@#Although the use of endoscopic clipping seemed to reduce the risk of developing delayed complications, further studies using a prospective design is required.

8.
Clinical Endoscopy ; : 563-569, 2021.
Article in English | WPRIM | ID: wpr-897738

ABSTRACT

Background/Aims@#Endoscopic resection (ER) has recently been accepted as the standard treatment modality for superficial nonampullary duodenal tumors (SNADTs). However, the procedure can cause adverse events such as perforation and bleeding. This study aimed to investigate the efficacy of prophylactic clipping in the prevention of delayed complications. @*Methods@#A retrospective review of the medical records of patients who underwent ER for SNADT from 3 centers was performed. Patients were divided into 2 groups: the immediate clipping group (ICG) and the no clipping group (NCG). Various baseline characteristics and factors associated with the appearance of delayed complications, such as size of the lesion, tumor location, histologic type, and co-morbidities, were compared between the two groups. @*Results@#A total of 99 lesions from 99 patients were included in this study. Fifty-two patients were allocated into ICG and 47 patients were allocated into NCG. Delayed bleeding occurred in 1 patient from ICG and in 8 patients from NCG. Delayed perforation occurred in 1 patient from ICG and in 3 patients from NCG. There were no procedure-related deaths in both groups. @*Conclusions@#Although the use of endoscopic clipping seemed to reduce the risk of developing delayed complications, further studies using a prospective design is required.

9.
Nutrition Research and Practice ; : 54-65, 2021.
Article in English | WPRIM | ID: wpr-875343

ABSTRACT

BACKGROUND/OBJECTIVES@#This study aimed to develop healthy, appetizing high-protein snacks with enhanced isolated soy protein for diabetic patients and determine the blood glucose and insulin response after being consumed by these patients.MATERIALS/METHODS: Thirty adult patients aged between 30 and 75 years, with a ≤ 10-year history of type 2 diabetes and hemoglobin A1c of < 7.5%, were enrolled in this study. They made 3 clinical visits at one-week intervals. The control group consumed 50 g carbohydrates (white bread), whereas the test groups consumed high-protein grain (HP_G) or high-protein chocolate (HP_C) after an 8-hrs fast. Blood (2 cm 3 ) was drawn at 15, 30, 45, 60, 90, and 120 min before and after consumption to analyze the blood glucose and insulin concentrations. @*RESULTS@#Compared to the commercial snacks, the developed high-protein snacks had belowaverage calorie, carbohydrate, and fat content and a 2.5-fold higher protein content. In diabetic patients who consumed these snacks, the postprandial blood glucose increased between 15 min and 2 h after consumption, which was significantly slower than the time taken for the blood glucose to increase in the patients who consumed the control food product (P< 0.001). Insulin secretion was significantly lower at 45 min after consumption (P < 0.05), showing that the highprotein snacks did not increase the blood glucose levels rapidly. The incremental area under the curve (iAUC), which indicated the degree of blood sugar and insulin elevation after food intake, was higher in the control group than the groups given the 2 developed snacks (P < 0.001), and there was no significant difference in insulin secretion. @*CONCLUSIONS@#The results of the postprandial blood glucose and insulin response suggest that high-protein snacks are potential convenient sources of high-quality protein and serve as a healthier alternative for patients with type 2 diabetes, who may have limited snack product choices. Such snacks may also provide balanced nutrition to pre-diabetic and obese individuals.

10.
Journal of the Korean Society of Biological Therapies in Psychiatry ; (3): 218-226, 2020.
Article | WPRIM | ID: wpr-836414

ABSTRACT

Objectives@#:Community managements for elderly are changing due to increased social and economic burdens.The purpose of this study was to find out if there is an effect on depression, anxiety, quality of life, and life management by using a care robot, which is a future technology. @*Methods@#:For 100 elderly patients who visited the hospital with cognitive impairment or type 2 diabetes, we install a care robot between August 20 and November 14, 2019. The self-report questionnaire was used to measure changes in depression, sleep quality, quality of life, and life management among patients. In this study, 77 patients completed the survey were compared before and after the use of a care robot. @*Results@#:It was confirmed that the elderly patients using the care robot improved in terms of depression, sleep quality, anxiety, and life management. When the mean values of the scores before and after the care robot intervention were compared, there was a significant decrease (p≤0.001) in depression scale. In the sleep quality category, there was a significant positive effect (p≤0.001). In quality of life category, anxiety/depression showed a significant decrease (p≤0.001). In the life management category, there was a significant improvement (p=0.004) in the cognitive impairment group, and especially in the drug compliance, patients with the cognitive impairment group had a positive effect (p=0.01). @*Conclusion@#:For elderly patients, the use of care robots as a non- pharmacological intervention can help improve depression, anxiety and sleep quality. In particular, in the cognitive impairment group, it is effective in improving life management.

11.
Journal of the Korean Fracture Society ; : 134-141, 2020.
Article | WPRIM | ID: wpr-836389

ABSTRACT

Purpose@#To evaluate the clinical and radiological outcomes of bipolar hemiarthroplasty using a polished cemented femoral stem for intertrochanteric fractures in elderly patients. @*Materials and Methods@#From July 2005 to May 2015, 48 patients diagnosed with intertrochanteric fractures underwent bipolar hemiarthroplasty. The mean age and follow-up period were 80.5 years and 30.5 months, respectively. The postoperative results were evaluated clinically and radiologically. @*Results@#The mean operation time was 100 minutes (range, 90-120 minutes), and the mean amount of blood loss was 334 ml (range, 170-500 ml). At the last follow-up, the mean Harris hip score (HHS), visual analogue scale (VAS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores were 82.2 (range, 76-90), 0.8 (range, 1-3), and 36 (range, 30-40), respectively. Walking was initiated using a walker for partial weight-bearing, and the mean walking time was 5.8 days (range, 3-14 days). Ambulatory ability was restored to a walking state before the injury in 36 cases (75.0%), and wheelchair ambulation was possible in 12 cases (25.0%). The instrumental activities of daily living (IADLs) were 17 patients (35.4%), and the basic activities of daily living (BADLs) were 31 patients (64.6%). @*Conclusion@#Polished cemented bipolar hemiarthroplasty can achieve secure fixation with no postoperative thigh pain. Restoring the preoperative walking ability will be more helpful for intertrochanteric fractures in elderly patients.

12.
Journal of the Korean Association of Oral and Maxillofacial Surgeons ; : 313-320, 2020.
Article | WPRIM | ID: wpr-834728

ABSTRACT

Objectives@#The aim of this study was to evaluate the relationship between masticatory muscle thickness and mandibular morphology in young Korean adults with normal occlusion and mandibular prognathism. @*Patients and Methods@#Multidetector computed tomography (MDCT) was used to measure the masticatory muscle thickness on the right side in 100 Korean young adults (50 normal occlusion group, 50 mandibular prognathism group). Cephalometric analysis was done to measure mandibular morphology. Pearson correlation analysis was done to investigate the relationship between the masticatory muscle thickness and mandibular morphometry. @*Results@#The four masticatory muscles showed positive correlation with intergonial width in all subjects. All muscles, except temporalis, positively correlated with height of the ramus and mandibular length. Positive correlation was also observed in all muscles, except medial pterygoid, with thickness of the ramus. In the normal occlusion group, all four masticatory muscles showed positive correlation with intergonial width and ramus thickness.Positive correlation was also observed in all muscles (except lateral pterygoid) with mandibular length. Masseter and lateral pterygoid positively correlated with height of the ramus. In the mandibular prognathism group, all masticatory muscles, except lateral pterygoid, showed positive correlation with intergonial width. The masseter muscle showed negative correlation with ANB. @*Conclusion@#The results suggest a positive correlation of the thickness of masticatory muscles with both horizontal and vertical dimensions of the mandible. However, thickness of the masseter was found to decrease in patients with increasing severity of mandibular prognathism.

13.
Journal of the Korean Association of Oral and Maxillofacial Surgeons ; : 288-291, 2020.
Article | WPRIM | ID: wpr-834698

ABSTRACT

Angiosarcoma is a rare malignant mesenchymal tumor of vascular or lymphatic origin and represents less than 1% of all malignant tumors. Radiation therapy is a standard treatment in many head and neck cancer cases, but ionizing radiation is associated with radiation carcinogenesis including radiation-induced angiosarcoma. In this article, we report a rare case of radiation-induced angiosarcoma found in a 58-year-old female patient who was previously diagnosed with an odontogenic keratocyst and mucoepidermoid carcinoma.

14.
Infection and Chemotherapy ; : 369-380, 2020.
Article | WPRIM | ID: wpr-834278

ABSTRACT

Background@#A novel antiviral agent, remdesivir (RDV), is a promising candidate treatment for coronavirus disease 2019 (COVID-19) in the absence of any proven therapy.Materials and @*Methods@#This retrospective case series included 10 patients with a clinically and laboratory confirmed diagnosis of severe COVID-19 pneumonia who had received RDV for 5 days (n = 5) or 10 days (n = 5) in the Phase III clinical trial of RDV (GS-US-540-5773) conducted by Gilead Sciences. The clinical and laboratory data for these patients were extracted. @*Results@#One patient in the 10-day group received RDV for only 5 days because of nausea and elevated liver transaminases. No patient had respiratory comorbidity. Seven patients had bilateral lesions and three had unilateral lesions on imaging. All patients had received other medications for COVID-19, including lopinavir/ritonavir and hydroxychloroquine, before administration of RDV. Five patients required supplemental oxygen and one required mechanical ventilation. All patients showed clinical and laboratory evidence of improvement.Half of the patients developed elevated liver transaminases and three had nausea. There were no adverse events exceeding grade 2. @*Conclusion@#Our experience indicates that RDV could be a therapeutic option for COVID-19.A well-designed randomized controlled clinical trial is now needed to confirm the efficacy of RDV in patients with COVID-19.

15.
The Korean Journal of Gastroenterology ; : 356-361, 2020.
Article | WPRIM | ID: wpr-834074

ABSTRACT

Autoimmune pancreatitis (AIP) is a rare and unique type of chronic pancreatitis. The prognosis of AIP, particularly when associated with pancreatic cancer or a related malignancy, is not known. Only a few cases, where metachronous pancreas-related cancer developed during follow-up, have been reported. Most of these patients either underwent surgery or steroid therapy. This paper reports a case of a 66-year-old woman with untreated type I AIP who developed peritoneal carcinomatosis more than 2 years later. Initially, the patient had a markedly elevated serum IgG4 level and a diffuse, infiltrative mass-like lesion in the pancreatic head, in which the biopsy results were consistent with type I AIP. The patient was not treated with steroids because of a cerebellar infarction. Twenty-eight months after the diagnosis of AIP, peritoneal carcinomatosis developed without noticeable changes in the pancreas from the initial findings.

16.
Journal of Korean Physical Therapy ; (6): 359-364, 2020.
Article in English | WPRIM | ID: wpr-900173

ABSTRACT

Purpose@#This study was undertaken to compare the efficacy of instrument assisted soft tissue mobilization (IASTM) and a neural dynamic technique (NDYT). As an intervention to treat spastic lower limb muscle tone, stiffness, and static balance in stroke patients. @*Methods@#Totally, 26 participants were assigned randomly to two groups: the IASTM (n=13) and NDYT (n=13) groups. Both groups were subjected to their respective technique for 15 minutes, 5 times a week, for 6 weeks. Muscle tone, stiffness, and static balance were evaluated before and after training, to compare both group changes. @*Results@#IASTM group showed significant decrease in the gastrocnemius medial region and semitendinosus muscle tone and stiffness (p0.05). @*Conclusion@#The results suggest that IASTM is an effective method for decreasing the muscle tone and stiffness in acute stroke patients.

17.
Journal of Korean Medical Science ; : e33-2020.
Article in English | WPRIM | ID: wpr-899757

ABSTRACT

BACKGROUND@#Although Helicobacter pylori is a key cause of gastric cancer development, its eradication rate has been decreasing by standard regimens. For successful eradication, duration of treatment has been issued for overcoming antibiotics resistance. We were to compare the eradication rate of 7-day vs. 14-day treatment in first- and second-line regimens.@*METHODS@#This study was an open-label randomized controlled trial. A total of 369 H. pylori-infected patients were enrolled and assigned either to 7-day or 14-day proton pump inhibitor (PPI)-based standard triple therapy (STT; PPI-clarithromycin-amoxicillin). Bismuth-containing quadruple therapy was used as second-line therapy. Eradication success was defined as a negative ¹³C-urea breath test.@*RESULTS@#In first-line treatment, eradication rate was 78.5% (106/135) and 78.6% (114/143) in the 7-day and 14-day treatment in per-protocol (PP) analysis (P = 0.805). In intention-to-treat (ITT) analysis, eradication rate was 64.0% (114/178) and 66.0% (126/191), respectively (P = 0.924). There was no significant difference in drug compliance (81.5% vs. 84.3%, P = 0.320). In second-line therapy, eradication rate was not significantly different in both treatments of PP analysis (91.7% [33/36] vs. 100% [45/45], P = 0.084). In the ITT analysis, eradication rate was 79.6% (35/44) and 90.4% (47/52), respectively (P = 0.080). Drug compliances were not significantly different between the two groups (95.5% vs. 98.1%, P = 0.728).@*CONCLUSION@#PPI-based STT for H. pylori is not efficient as a first-line therapy both in 7 days and 14 days in Korea. Although bismuth-containing quadruple therapy for 14 days as a second line therapy tend to show higher eradication rate compared to 7-day therapy, this should be elucidated by further larger scaled studies.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02487511

18.
Journal of Korean Physical Therapy ; (6): 359-364, 2020.
Article in English | WPRIM | ID: wpr-892469

ABSTRACT

Purpose@#This study was undertaken to compare the efficacy of instrument assisted soft tissue mobilization (IASTM) and a neural dynamic technique (NDYT). As an intervention to treat spastic lower limb muscle tone, stiffness, and static balance in stroke patients. @*Methods@#Totally, 26 participants were assigned randomly to two groups: the IASTM (n=13) and NDYT (n=13) groups. Both groups were subjected to their respective technique for 15 minutes, 5 times a week, for 6 weeks. Muscle tone, stiffness, and static balance were evaluated before and after training, to compare both group changes. @*Results@#IASTM group showed significant decrease in the gastrocnemius medial region and semitendinosus muscle tone and stiffness (p0.05). @*Conclusion@#The results suggest that IASTM is an effective method for decreasing the muscle tone and stiffness in acute stroke patients.

19.
Journal of Korean Medical Science ; : e33-2020.
Article in English | WPRIM | ID: wpr-892053

ABSTRACT

BACKGROUND@#Although Helicobacter pylori is a key cause of gastric cancer development, its eradication rate has been decreasing by standard regimens. For successful eradication, duration of treatment has been issued for overcoming antibiotics resistance. We were to compare the eradication rate of 7-day vs. 14-day treatment in first- and second-line regimens.@*METHODS@#This study was an open-label randomized controlled trial. A total of 369 H. pylori-infected patients were enrolled and assigned either to 7-day or 14-day proton pump inhibitor (PPI)-based standard triple therapy (STT; PPI-clarithromycin-amoxicillin). Bismuth-containing quadruple therapy was used as second-line therapy. Eradication success was defined as a negative ¹³C-urea breath test.@*RESULTS@#In first-line treatment, eradication rate was 78.5% (106/135) and 78.6% (114/143) in the 7-day and 14-day treatment in per-protocol (PP) analysis (P = 0.805). In intention-to-treat (ITT) analysis, eradication rate was 64.0% (114/178) and 66.0% (126/191), respectively (P = 0.924). There was no significant difference in drug compliance (81.5% vs. 84.3%, P = 0.320). In second-line therapy, eradication rate was not significantly different in both treatments of PP analysis (91.7% [33/36] vs. 100% [45/45], P = 0.084). In the ITT analysis, eradication rate was 79.6% (35/44) and 90.4% (47/52), respectively (P = 0.080). Drug compliances were not significantly different between the two groups (95.5% vs. 98.1%, P = 0.728).@*CONCLUSION@#PPI-based STT for H. pylori is not efficient as a first-line therapy both in 7 days and 14 days in Korea. Although bismuth-containing quadruple therapy for 14 days as a second line therapy tend to show higher eradication rate compared to 7-day therapy, this should be elucidated by further larger scaled studies.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02487511

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