BACKGROUND: This study was designed to assess the acceptability and the diagnostic accuracy of unsedated ultrathin EGD (uUT-EGD) by using a newly developed 5.2-mm-diameter videoscope compared with unsedated small-caliber EGD (uSC-EGD) by using a 6.5-mm-diameter videoscope or sedated conventional EGD (sC-EGD) by using a 9.0-mm-diameter videoscope. DESIGN: First, 80 patients who had undergone uSC-EGD approximately 1 year earlier were randomized to receive uUT-EGD (n = 40) or uSC-EGD (n = 40). Endoscopist satisfaction and patient comfort were assessed by using a 10-cm visual analog scale. Patient comfort level was compared with that of the previous uSC-EGD. Second, 40 patients who had undergone sC-EGD within the previous 1.5 years underwent uUT-EGD. The optical quality and EGD findings of uUT-EGD were compared with those of the previous sC-EGD. Last, in the 80 patients undergoing uUT-EGD, the ability to identify a validated endoscopic marker, the rearrangement of collecting venues (RAC) pattern, for no Helicobacter pylori, was compared with the results of a (13)C-urea breath test or H pylori stool antigen test. SETTING: Showa Inan General Hospital, Komagane, Japan. PATIENTS: A total of 120 patients who undergo EGD every year as part of a gastric cancer surveillance program. RESULTS: The patient comfort level of uUT-EGD was significantly better than that of uSC-EGD (P < .0001). The optical quality of the endoscopic images and the EGD findings of uUT-EGD were similar to those of the previous sC-EGD. The overall sensitivity, specificity, and accuracy of the RAC pattern in uUT-EGD in recognizing H pylori-uninfected patients were 90%, 100%, and 93%, respectively. The interobserver agreement for RAC was good (kappa = 0.42). CONCLUSIONS: The use of a 5.2-mm-diameter videoscope is expected to enhance the patient acceptance of unsedated EGD.
RCT Entities:
BACKGROUND: This study was designed to assess the acceptability and the diagnostic accuracy of unsedated ultrathin EGD (uUT-EGD) by using a newly developed 5.2-mm-diameter videoscope compared with unsedated small-caliber EGD (uSC-EGD) by using a 6.5-mm-diameter videoscope or sedated conventional EGD (sC-EGD) by using a 9.0-mm-diameter videoscope. DESIGN: First, 80 patients who had undergone uSC-EGD approximately 1 year earlier were randomized to receive uUT-EGD (n = 40) or uSC-EGD (n = 40). Endoscopist satisfaction and patient comfort were assessed by using a 10-cm visual analog scale. Patient comfort level was compared with that of the previous uSC-EGD. Second, 40 patients who had undergone sC-EGD within the previous 1.5 years underwent uUT-EGD. The optical quality and EGD findings of uUT-EGD were compared with those of the previous sC-EGD. Last, in the 80 patients undergoing uUT-EGD, the ability to identify a validated endoscopic marker, the rearrangement of collecting venues (RAC) pattern, for no Helicobacter pylori, was compared with the results of a (13)C-urea breath test or H pylori stool antigen test. SETTING: Showa Inan General Hospital, Komagane, Japan. PATIENTS: A total of 120 patients who undergo EGD every year as part of a gastric cancer surveillance program. RESULTS: The patient comfort level of uUT-EGD was significantly better than that of uSC-EGD (P < .0001). The optical quality of the endoscopic images and the EGD findings of uUT-EGD were similar to those of the previous sC-EGD. The overall sensitivity, specificity, and accuracy of the RAC pattern in uUT-EGD in recognizing H pylori-uninfected patients were 90%, 100%, and 93%, respectively. The interobserver agreement for RAC was good (kappa = 0.42). CONCLUSIONS: The use of a 5.2-mm-diameter videoscope is expected to enhance the patient acceptance of unsedated EGD.