A Multi-Center, Double-Blind Randomized Controlled Phase III Clinical Trial to Evaluate the Antiviral Activity and Safety of DA-2802 (Tenofovir Disoproxil Orotate) and Viread (Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B Patients

Background@#Tenofovir disoproxil fumarate (TDF, Viread® ) had been used as a standard treatment option of chronic hepatitis B (CHB). This clinical trial was conducted to evaluate the efficacy and safety of DA-2802 (tenofovir disoproxil orotate) compared to TDF. @*Methods@#The present study was a double blind randomized controlled trial. Patients with CHB were recruited from 25 hospitals in Korea and given DA-2802 at a dose of 319 mg once daily or Viread® at a dose of 300 mg once daily for 48 weeks from March 2017 to January 2019. Change in hepatitis B virus (HBV) DNA level at week 48 after dosing compared to baseline was the primary efficacy endpoint. Secondary efficacy endpoints were proportions of subjects with undetectable HBV DNA, those with normal alanine aminotransferase (ALT) levels, and those with loss of hepatitis B envelop antigen (HBeAg), those with loss of hepatitis B surface antigen (HBsAg). Adverse events (AEs) were also investigated. @*Results@#A total of 122 patients (DA-2802 group: n = 61, Viread® group: n = 61) were used as full analysis set for efficacy analysis. Mean age, proportion of males, laboratory results and virologic characteristics were not different between the two groups. The change in HBV DNA level at week 48 from baseline was −5.13 ± 1.40 in the DA-2802 group and −4.97 ± 1.40 log 10 copies/mL in the Viread® group. The analysis of primary endpoint using the nonparametric analysis of covariance showed statistically significant results (P < 0.001), which confirmed non-inferiority of DA-2802 to Viread® by a prespecified noninferiority margin of 1. The proportion of undetectable HBV DNA was 78.7% in the DA-2802 group and 75.4% in the Viread® group (P = 0.698). The proportion of subjects who had normal ALT levels was 75.4% in the DA-2802 group and 73.3% in the Viread® group (P = 0.795). The proportion of those with HBeAg loss was 8.1% in the DA-2802 group and 10.8% in the Viread® group (P = 1.000). No subject showed HBsAg loss. The frequency of AEs during treatment was similar between the two groups. Most AEs were mild to moderate in severity. @*Conclusion@#DA-2802 is considered an effective and safe treatment for patients with CHB.

Prevalence, Awareness, and Treatment of Hepatitis C Virus Infection in South Korea: Evidence from the Korea National Health and Nutrition Examination Survey

Background/Aims@#This study aimed to investigate the epi-demiology of hepatitis C virus (HCV) infection in the Korean general population and the awareness and treatment status of HCV infection among anti-HCV-positive persons. @*Methods@#We used data from the Korea National Health and Nutrition Examination Survey (KNHNES) collected between 2012 and 2016. All the participants aged ≥10 years in the KNHNES were tested for the anti-HCV antibody. Anti-HCV-positive persons were tested for HCV RNA and assessed for their awareness and treatment experience regarding HCV infec-tion. @*Results@# The prevalence of anti-HCV was 0.66% (95% confidence interval, 0.56% to 0.78%) among Koreans aged ≥10 years, representing an estimated 278,819 anti-HCV-pos-itive persons, and 0.71% (95% confidence interval, 0.60% to 0.84%) among Koreans aged ≥20 years. The prevalence of anti-HCV increased with age and had significant geographic variation. The positive rate of HCV RNA in anti-HCV-positive persons was 33.5% and increased with age. The rate of HCV infection awareness was 15.2% (35/250) among antiHCV-positive persons and 30.5% (18/59) among HCV RNApositive persons. Among the participants, 13.5% of HCV RNA-positive persons had been treated for HCV infection. @*Conclusions@# The prevalence of anti-HCV among Koreans aged ≥20 years was 0.71%; one-third of anti-HCV-positive persons tested HCV RNA-positive. The awareness and treat-ment rates of HCV infection were low among HCV-infected persons. Therefore, active measures should be taken to diagnose and treat persons unaware of HCV infection.

Feasibility of Robot-Assisted Gait Training with an End-Effector Type Device for Various Neurologic Disorders

Robots are being used to assist the recovery of walking ability for patients with neurologic disorders. This study aimed to evaluate the feasibility and functional improvement of training with robot-assisted gait training (RAGT) using the Morning Walk®, an end-effector type robot using footplates and saddle seat support. A total of 189 individuals (65.1% men, 34.9% women; mean age, 53.2 years; age range: 5–87 years) with brain lesions, spinal cord injuries, Parkinson's disease, peripheral neuropathies, and pediatric patients were involved in this retrospectively registered clinical trial. Each participant performed 30 minutes of RAGT, five times a week, for a total of 24 sessions. Failure was defined as an inability to complete all 24 sessions, and the reasons for discontinuation were analyzed. Parameters of Medical Research Council scales and Functional Ambulation Categories were analyzed before and after RAGT training. Among the 189 patients, 22 (11.6%) failed to complete the RAGT. The reasons included decreased cooperation, musculoskeletal pain, saddle seat discomfort, excessive body-weight support, joint spasticity or restricted joint motion, urinary incontinence from an indwelling urinary catheter, and fatigue. Comparison between the pre- and post-training motor and ambulatory functions showed significant improvement. The result of the study indicates that the Morning Walk® is feasible and safe and useful for functional improvement in patients with various neurologic disordersTRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0003627

Feasibility of Robot-Assisted Gait Training with an End-Effector Type Device for Various Neurologic Disorders

Robots are being used to assist the recovery of walking ability for patients with neurologic disorders. This study aimed to evaluate the feasibility and functional improvement of training with robot-assisted gait training (RAGT) using the Morning Walk®, an end-effector type robot using footplates and saddle seat support. A total of 189 individuals (65.1% men, 34.9% women; mean age, 53.2 years; age range: 5–87 years) with brain lesions, spinal cord injuries, Parkinson's disease, peripheral neuropathies, and pediatric patients were involved in this retrospectively registered clinical trial. Each participant performed 30 minutes of RAGT, five times a week, for a total of 24 sessions. Failure was defined as an inability to complete all 24 sessions, and the reasons for discontinuation were analyzed. Parameters of Medical Research Council scales and Functional Ambulation Categories were analyzed before and after RAGT training. Among the 189 patients, 22 (11.6%) failed to complete the RAGT. The reasons included decreased cooperation, musculoskeletal pain, saddle seat discomfort, excessive body-weight support, joint spasticity or restricted joint motion, urinary incontinence from an indwelling urinary catheter, and fatigue. Comparison between the pre- and post-training motor and ambulatory functions showed significant improvement. The result of the study indicates that the Morning Walk® is feasible and safe and useful for functional improvement in patients with various neurologic disordersTRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0003627

Feasibility of Robot-Assisted Gait Training with an End-Effector Type Device for Various Neurologic Disorders

Robots are being used to assist the recovery of walking ability for patients with neurologic disorders. This study aimed to evaluate the feasibility and functional improvement of training with robot-assisted gait training (RAGT) using the Morning Walk®, an end-effector type robot using footplates and saddle seat support. A total of 189 individuals (65.1% men, 34.9% women; mean age, 53.2 years; age range: 5–87 years) with brain lesions, spinal cord injuries, Parkinson's disease, peripheral neuropathies, and pediatric patients were involved in this retrospectively registered clinical trial. Each participant performed 30 minutes of RAGT, five times a week, for a total of 24 sessions. Failure was defined as an inability to complete all 24 sessions, and the reasons for discontinuation were analyzed. Parameters of Medical Research Council scales and Functional Ambulation Categories were analyzed before and after RAGT training. Among the 189 patients, 22 (11.6%) failed to complete the RAGT. The reasons included decreased cooperation, musculoskeletal pain, saddle seat discomfort, excessive body-weight support, joint spasticity or restricted joint motion, urinary incontinence from an indwelling urinary catheter, and fatigue. Comparison between the pre- and post-training motor and ambulatory functions showed significant improvement. The result of the study indicates that the Morning Walk® is feasible and safe and useful for functional improvement in patients with various neurologic disordersTRIAL REGISTRATION: Clinical Research Information Service Identifier: KCT0003627

The General Rules for the Study of Primary Liver Cancer

The General Rules for the Study of Primary Liver Cancer was published in June 2001 as the first edition. Since then, the 5th edition of the General Rules for the Study of Primary Liver Cancer was published by the 17th Committee of the Korean Liver Cancer Association based on the most recent data. The 5th edition of the General Rules for the Study of Primary Liver Cancer ranged over numerous topics such as anatomy, medical assessment of the patients, staging of hepatocellular carcinoma, description of the image findings, summary of hepatic resection, description of the surgical specimens, liver transplantation, reporting the pathological findings, pathological examinations of liver specimen, non-surgical treatment, radiotherapy, and assessment of tumor response after non-surgical treatment of hepatocellular carcinoma. The 5th General Rules for the Study of Primary Liver Cancer will not only become the basis of academic development for liver cancer studies in Korea, but also serve as the primary form of national liver cancer data accumulation based on standardized rules.

The Usefulness of Argon Plasma Coagulation Compared with Endoscopic Submucosal Dissection to Treat Gastric Adenoma / 대한소화기학회지

BACKGROUND/AIMS: To date, the best therapeutic modality for gastric adenoma, especially low-grade adenoma, has not been established. The aim of this study was to assess the usefulness of argon plasma coagulation (APC) in treating gastric adenoma compared with endoscopic submucosal dissection (ESD). METHODS: We included 210 patients with gastric adenoma, who underwent treatment with either APC (97 patients) or ESD (113 patients). The clinical and pathologic characteristics, mean duration of hospital stay, complications, and recurrence rates between the two groups were compared. RESULTS: The mean adenoma size was 0.9 cm and 1.1 cm in the APC group and ESD group, respectively (p<0.001). The mean duration of hospital stay was significantly shorter in the APC group than in the ESD group (1.6 days vs. 5.8 days, p<0.001). Complications did not occur in the APC group. However, one case of perforation (0.9%) and 6 cases of bleeding (5.3%) occurred in the ESD group. The recurrence rates were 15.3% (15/97 patients) in the APC group and 3.5% (4/113 patients) in the ESD group (p=0.003). The proportion of hospitalization was less in the APC group (43.3%, 42/97) than in the ESD group (100.0%, 113/113) (p<0.001). Medical expense was less in the APC group (377,172 won) than in the ESD group (1,430,610 won) (p<0.001). CONCLUSIONS: The findings of this study suggest that APC is a safe treatment method for gastric adenoma without serious complications. However, regular endoscopic follow-up is necessary to detect any residual or recurrent lesions due to the relatively high rate of local recurrence after APC.

Clinical Characteristics and Treatment Outcome of Peginterferon Plus Ribavirin in Patients Infected with Genotype 6 Hepatitis C Virus in Korea: A Multicenter Study

BACKGROUND/AIMS: Because of the limited geographic distribution, there have been insufficient data regarding hepatitis C virus (HCV) genotype 6 in Korea. This study aimed to investigate the clinical characteristics and available treatment outcomes of patients with genotype 6 HCV in Korea. METHODS: From 2004 to 2014, data were collected from Korean patients infected with genotype 6 HCV in eight hospitals. RESULTS: Thirty-two patients had genotype 6 HCV. The median age was 44 years, and 6c was the most common subtype. The baseline median alanine transaminase level was 88 (21 to 1,019) IU/mL, and the HCV RNA level was 1,405,000 (96,500 to 28,844,529) IU/mL. Twenty-five patients were treated with peginterferon (PEG-IFN) and ribavirin. Three follow-up losses occurred. Additionally, 13 patients attained a sustained virologic response (SVR), seven patients relapsed, and two patients exhibited a null response. The SVR rates were 40% and 75% for the 24- and more than 48-week treatments, respectively, and five of the six patients who achieved a rapid virologic response (RVR) attained a SVR. CONCLUSIONS: Korean patients infected with genotype 6 HCV are relatively young, and 6c is the most common subtype. When treated with PEG-IFN and ribavirin, the SVR rate was 52%. Similar to other genotypes, a longer duration of treatment and attainment of RVR are important for SVR.

Intramural Duodenal Hematoma after Transpancreatic Septotomy during ERCP: A Case Report and Literature Review / 대한췌담도학회지

Transpancreatic septotomy is known to improve the success rate of selective bile duct cannulation in endoscopic retrograde cholangiopancreatography. Recent retrospective study reported that transpancreatic septotomy is more effective and safer than needle knife sphincterotomy. Herein, we report a case of patient with gallstone pancreatitis who suffered from intramural duodenal hematoma after transpancreatic septotomy that caused obstruction of the duodenum and hypovolemic shock. The intramural hematoma improved after conservative management. The rare adverse event such as intramural duodenal hematoma seems to be considered after transpancreatic septotomy, especially when acute pancreatitis is accompanied.

Acute pancreatitis associated with pegylated interferon-alpha-2a therapy in chronic hepatitis C

Chronic hepatitis C virus (HCV) infection is a major cause of liver cirrhosis and hepatocellular carcinoma. Combination therapy of pegylated interferon-alpha (PEG-IFN-α) and ribavirin (RBV) is a current standard treatment for chronic HCV infection in Korea, which has considerable adverse effects. Acute pancreatitis is a rare complication of PEG-IFN-α administration. We report a case of a 62-year-old female who experienced acute pancreatitis after 4 weeks of PEG-IFN-α-2a and RBV combination therapy for chronic HCV infection. The main cause of the acute pancreatitis in this case was probably PEG-IFN-α rather than RBV for several reasons. A few cases have been reported in which acute pancreatitis occurred during treatment with PEG-IFN-α-2b. This is the first report of acute pancreatitis associated with PEG-IFN-α-2a in Korea.

Fanconi Syndrome Associated with Long-term Adefovir and Subsequent Tenofovir Therapy for Chronic Hepatitis B Infection / 대한내과학회지

Adefovir dipivoxil (ADV) and tenofovir disoproxil fumarate (TDF) are nucleotide analogues used to treat chronic hepatitis B (CHB) infection. Nephrotoxicity associated with the use of these medications causes Fanconi syndrome, a rare condition involving generalized dysfunction of the proximal renal tubule causing impaired reabsorption of glucose, uric acid, and phosphate. Fanconi syndrome has been previously reported in patients with human immunodeficiency virus (HIV) or HIV-CHB coinfection treated with other antiretroviral therapies. However, it is rarely reported in patients with CHB monoinfection. We observed a case of Fanconi syndrome in a 61-year-old woman with CHB monoinfection and a history of long-term ADV therapy (42 months), followed by TDF treatment for 9 months. She presented with ankle pain and a tingling sensation in both lower extremities. Laboratory tests revealed hypokalemia, hypocalcemia, hypophosphatemia, hypouricemia, proteinuria, and glycosuria. This case illustrates the importance of recognizing Fanconi syndrome associated with nucleotide analogue treatment and the need to carefully observe symptoms and monitor renal function in these patients.

Obstructive ileus caused by phlebosclerotic colitis

A 57-year-old man with chronic kidney disease and a history of using numerous herbal medications visited Inje University Ilsan Paik Hospital for abdominal pain and vomiting. An abdominal radiograph showed diffuse small bowel distension containing multiple air-fluid levels and extensive calcifications along the colon. Computed tomography showed colon wall thickening with diffuse calcification along the colonic mesenteric vein and colonic wall. Colonoscopy, performed without bowel preparation, showed bluish edematous mucosa from the transverse to the distal sigmoid colon, with multiple scar changes. At the mid transverse colon, a stricture was noted and the scope could not pass through. A biopsy of the stricture site revealed nonspecific changes. The patient was diagnosed with phlebosclerotic colitis. After the colonoscopy, the obstructive ileus spontaneously resolved, and the patient was discharged without an operation. Currently, after 2 months of follow-up, the patient has remained asymptomatic. Herein, we report the rare case of an obstructive ileus caused by phlebosclerotic colitis with a colon stricture.

Obstructive ileus caused by phlebosclerotic colitis

A 57-year-old man with chronic kidney disease and a history of using numerous herbal medications visited Inje University Ilsan Paik Hospital for abdominal pain and vomiting. An abdominal radiograph showed diffuse small bowel distension containing multiple air-fluid levels and extensive calcifications along the colon. Computed tomography showed colon wall thickening with diffuse calcification along the colonic mesenteric vein and colonic wall. Colonoscopy, performed without bowel preparation, showed bluish edematous mucosa from the transverse to the distal sigmoid colon, with multiple scar changes. At the mid transverse colon, a stricture was noted and the scope could not pass through. A biopsy of the stricture site revealed nonspecific changes. The patient was diagnosed with phlebosclerotic colitis. After the colonoscopy, the obstructive ileus spontaneously resolved, and the patient was discharged without an operation. Currently, after 2 months of follow-up, the patient has remained asymptomatic. Herein, we report the rare case of an obstructive ileus caused by phlebosclerotic colitis with a colon stricture.

Ischemic Colitis Caused by Terlipressin during Treatment of Hepatorenal Syndrome / 대한내과학회지

Terlipressin, a vasopressin agonist, is widely used to treat variceal bleeding and hepatorenal syndrome in patients with liver cirrhosis. Terlipressin increases systemic vascular resistance, particularly in the splanchnic area, thus decreasing portal pressure. Although terlipressin is associated with a lower incidence of severe cardiovascular complications than is vasopressin, terlipressin can induce serious ischemic complications including myocardial infarction, skin necrosis, and bowel ischemia in < 1% of patients. We report the case of a 79-year-old female with liver cirrhosis treated with terlipressin to control hepatorenal syndrome that developed into ischemic colitis. The patient improved upon cessation of terlipressin and provision of supportive care.

Feasibility of alpha-fetoprotein as a diagnostic tool for hepatocellular carcinoma in Korea

BACKGROUND/AIMS: The aim of this study was to evaluate the feasibility of alpha-fetoprotein (AFP) as a diagnostic tool for hepatocellular carcinoma (HCC) in Korean patients. METHODS: We retrospectively reviewed the medical records of HCC and cirrhosis patients at three hospitals. For each HCC patient, a cirrhosis patient matched for age, sex, etiology, and Child-Pugh classification was selected by simple random sampling. The performance of AFP in the diagnosis of HCC was determined using receiver operating characteristic curve analysis. RESULTS: A total of 732 patients with HCC or cirrhosis were selected for each case and the control groups. The mean age was 54 years, and 72.4% of patients were male. The mean serum AFP levels in the HCC group and cirrhosis group were 3,315.6 and 117.2 ng/mL, respectively (p < 0.001). The area under the receiver operating characteristic curve for all HCC patients was 0.757. The sensitivity, specificity, and positive predictive value of AFP was 50.55%, 87.70%, and 80.43%, respectively, at a cut-off of 20 ng/mL; 37.70%, 95.90%, and 90.20%, respectively, at a cut-off of 100 ng/mL, and 30.05%, 97.27%, and 91.67%, respectively, at a cut-off of 200 ng/mL. A cut-off of 100 ng/mL was more sensitive than one of 200 ng/mL with equivalent specificity and positive predictive value. CONCLUSIONS: The cut-off AFP value for early-stage HCC was 17.4 ng/mL. Our study cautiously suggests that AFP has a role in the diagnosis of HCC, and that the appropriate value of AFP for the diagnosis of HCC may be 100 ng/mL rather than 200 ng/mL.

Combination transarterial chemoembolization and radiofrequency ablation therapy for early hepatocellular carcinoma

BACKGROUND/AIMS: We compared the recurrence of hepatocellular carcinoma (HCC) and the survival of patients who received radiofrequency ablation (RFA) after transarterial chemoembolization (TACE) with patients treated with TACE or RFA alone. METHODS: This study included 201 patients with HCC, who were consecutively enrolled at Seoul St. Mary's Hospital between December 2004 and February 2010. Inclusion criteria were a single HCC < or = 5.0 cm or up to three HCCs < or = 3.0 cm. We used a propensity score model to compare HCC patients (n = 87) who received RFA after TACE (TACE + RFA) with those who received TACE (n = 71) or RFA alone (n = 43). RESULTS: The median follow-up period was 33.3 months (range, 6.8 to 80.9). The TACE + RFA group showed significantly lower local recurrence than the RFA or TACE groups (hazard ratio [HR], 0.309; 95% confidence interval [CI], 0.130 to 0.736; p = 0.008; and HR, 0.352; 95% CI, 0.158 to 0.787; p = 0.011, respectively). The overall survival was significantly better in the TACE + RFA group compared to the RFA group (HR, 0.422; 95% CI, 0.185 to 0.964; p = 0.041). However, the survival benefit was not different between the TACE + RFA and TACE groups (p = 0.124). Subgroup analysis showed that among patients with a tumor size < 3 cm, the TACE + RFA group had significantly better long-term survival than those in the TACE or RFA groups (p = 0.017, p = 0.004, respectively). CONCLUSIONS: TACE + RFA combination treatment showed favorable local recurrence and better overall survival rates in early-stage HCC patients. Patients with tumors < 3 cm are likely to benefit more from TACE + RFA combination treatment. Additional studies are needed for the selection of suitable HCC patients for TACE + RFA treatment.

Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide analogue-naive and nucleos(t)ide analogue-experienced chronic hepatitis B patients

BACKGROUND/AIMS: This study investigated the antiviral effects of tenofovir disoproxil fumarate (TDF) monotherapy in nucleos(t)ide analogue (NA)-naive and NA-experienced chronic hepatitis B (CHB) patients. METHODS: CHB patients treated with TDF monotherapy (300 mg/day) for > or =12 weeks between December 2012 and July 2014 at a single center were retrospectively enrolled. Clinical, biochemical, and virological parameters were assessed every 12 weeks. RESULTS: In total, 136 patients (median age 49 years, 96 males, 94 HBeAg positive, and 51 with liver cirrhosis) were included. Sixty-two patients were nucleos(t)ide (NA)-naive, and 74 patients had prior NA therapy (NA-exp group), and 31 patients in the NA-exp group had lamivudine (LAM)-resistance (LAM-R group). The baseline serum hepatitis B virus (HBV) DNA level was 4.9+/-2.3 log IU/mL (mean+/-SD), and was higher in the NA-naive group than in the NA-exp and LAM-R groups (5.9+/-2.0 log IU/mL vs 3.9+/-2.0 log IU/mL vs 4.2+/-1.7 log IU/mL, P<0.01). The complete virological response (CVR) rate at week 48 in the NA-naive group (71.4%) did not differ significantly from those in the NA-exp (71.3%) and LAM-R (66.1%) groups. In multivariate analysis, baseline serum HBV DNA was the only predictive factor for a CVR at week 48 (hazard ratio, 0.809; 95% confidence interval, 0.729-0.898), while the CVR rate did not differ with the NA experience. CONCLUSIONS: TDF monotherapy was effective for CHB treatment irrespective of prior NA treatment or LAM resistance. Baseline serum HBV DNA was the independent predictive factor for a CVR.

Long-term virological outcome in chronic hepatitis B patients with a partial virological response to entecavir

BACKGROUND/AIMS: The clinical outcome of patients with a partial virological response (PVR) to entecavir (ETV), in particular nucloes(t)ide analogue (NA)-experienced patients, has not been thoroughly investigated. The aim of the present study was to assess long-term outcomes in NA-naive and NA-experienced chronic hepatitis B patients with a PVR to ETV. METHODS: Chronic hepatitis B patients treated with ETV (0.5 mg/day) for at least 1 year were enrolled retrospectively. PVR was defined as a decrease in hepatitis B virus (HBV) DNA titer of more than 2 log10 IU/mL, yet with residual serum HBV DNA, as determined by real time-polymerase chain reaction, at week 48 of ETV therapy. RESULTS: A total of 202 patients (127 NA-naive and 75 NA-experienced, male 70.8%, antigen positive 53.2%, baseline serum HBV DNA 6.2 +/- 1.5 log10 IU/mL) were analyzed. Twenty-eight patients demonstrated a PVR. The PVR was associated with a high serum HBV DNA titer at baseline and at week 24. Virological response (< 60 IU/mL) was achieved in 46.2%, 61.5%, 77.6%, and 85% of patients with PVR at week 72, 96, 144, and 192, respectively. Resistance to antivirals developed in two NA-experienced patients. Failure of virological response (VR) in patients with PVR was associated with high levels of serum HBV DNA at week 48. CONCLUSIONS: Patients with PVR to ETV had favorable long-term virological outcomes. The low serum level of HBV DNA (< 200 IU/mL) at week 48 was associated with subsequent development of a VR in patients with PVR to ETV.

Is tenofovir disoproxil fumarate an all-powerful weapon in the treatment of chronic hepatitis B?

No abstract available.

Difference in Adenoma Detection Rates according to Colonoscopic Withdrawal Times and the Level of Expertise / 대한소화기학회지

BACKGROUND/AIMS: Adequate screening colonoscopy in the general population decreases the mortality associated with colorectal cancer through detection and removal of adenomatous polyps. Prolonged colonoscopic withdrawal times (>6 min) are reportedly beneficial for adenoma detection rates (ADRs). However, the quality of the endoscopist compared with colonoscopic withdrawal times is not known. The aims of this study were to investigate the difference in ADRs between trainees and experienced examiners. METHODS: A total of 967 consecutive patients who underwent screening colonoscopy in a single University hospital from June 2010 to November 2011 were enrolled in this prospective observational study. Colonoscopy was performed by four experienced staff and seven gastroenterology fellows. RESULTS: Seven gastroenterology fellows performed 633 colonoscopies and four experienced staff performed 334 colonoscopies. The overall detection rates of colorectal adenoma were 31.5% with ADRs of fellows and staff of 29.4% and 35.6%, respectively (p=0.047). Fellows also showed lower advanced ADRs (5.7% vs. 9.9%, p=0.016), and fellows had longer mean withdrawal times than staff (12.4+/-4.9 min vs. 8.2+/-4.1 min, p<0.001). Multivariate analysis showed significantly increased ADRs and advanced ADRs for staff compared with fellows (adjusted OR 2.41, 95% CI 1.70-3.43; adjusted OR 2.55, 95% CI 1.47-4.45, respectively). CONCLUSIONS: ADRs were significantly lower when colonoscopy was performed by trainees, although withdrawal times were longer than those of staff. Our results demonstrated that the quality of colonoscopy, as measured by ADRs, may be improved by experienced examiners.