| Magnetically controlled capsule endoscopy(MCE) has been widely used in clinical practice due to the characteristics of painlessness,noninvasiveness and favorable diagnostic accuracy as conventional esophagogastroduodenoscopy(EGD).However,the upper gastrointestinal tract(UGI)and small bowel continue to present challenges for MCE,especially in complete viewing of esophagus and duodenum,which is mainly attributed to two technical limitations.Firstly,the photoelectric technologies related to frame rate,field of view,image resolution and battery life are not in the most ideal state.Secondly,it is difficult for MCE to achieve active and effective control in esophagus and duodenum with its rapid transit.Therefore,we developed the second-generation MCE(MCE-2)with improved properties and a new detachable string MCE(DS-MCE)with a novel inspecting method to further promote the complete observation in UGI tract and small bowel,making a one-stop examination of whole digestive tract possibility.Part Ⅰ Preliminary clinical study of second-generation magnetically controlled capsule endoscopy with improved image resolution and adaptive frame rate: a prospective randomized controlled trial.Aims: MCE-2 highlighted with improved properties in photoelectric technology,and we aimed to evaluate whether it can make better clinical outcome.Methods: Consecutive patients undergoing MCE examination were prospectively enrolled and randomized in a 1:1 ratio to swallow the first-generation MCE(MCE-1)or MCE-2.The main outcomes included visualization of the esophagus,stomach and duodenum,operation related time in UGI tract and small bowel,maneuverability,image quality,detection rate of lesions,as well as safety evaluation.Results:(1)A total of 80 subjects(40 in each group)(mean age 46.5±13.8 years,range24-78 years)were enrolled and finished MCE-1 or MCE-2 examination from May to June2019,and there was no statistical difference in baseline characteristics between two groups.(2)MCE-2 greatly improved the visualization of esophagus as the frames captured for esophageal mucosa and Z-line were 171.00(IQR,81.25-409.25)and 2.00(IQR,0-13.00),significantly increased from those in MCE-1 group with 97.00(IQR,42.00-160.25)and 0.00(IQR,0-2.75)(P=0.002 and 0.028,respectively),and circumferential viewing of Z-line was also greatly improved(P=0.043).An obvious upward trend of the detection of Z-line(42.6%vs.60.0%,P=0.117)and duodenal papilla(7.5% vs.15.0%,P=0.479)existed in MCE-2group.(3)MCE-2 can dramatically shorten the gastric examination time from 7.78 ± 0.97 to5.27 ± 0.74 min,and extend the total running time from 702.83(IQR,648.47-856.10)to1001.99 min(IQR,774.42-1207.38 min,P<0.001).Esophageal transit time,gastric transit time and small-bowel transit time were similar between the two groups.(4)Compared with MCE-1 group,the image quality under MCE-2 was better(7.90±0.61 vs.8.63±0.57,P<0.001),and maneuverability of fluency,comfortableness and stability was significantly improved(10.05±1.04 vs.13.28±0.90,P<0.001).(5)There was no significant difference in detection of inflammation and focal lesions,and two tumors(one esophagus cancer and one gastric cancer)were both detected under MCE-2.(6)No adverse events such as capsule retention and aspiration were observed in all patients during the 2-week follow up period.Conclusions: MCE-2 showed better performance in UGI mucosal visualization,examination duration,image quality and maneuverability,making benefits for both patients and doctors.Part Ⅰ Detachable string magnetically controlled capsule endoscopy for complete examination of the upper gastrointestinal tract and small bowel: a prospective self-controlled trialAims: We developed a new detachable string magnetically controlled capsule endoscopy(DS-MCE)with a modified inspecting method,and aimed to assess its feasibility and safety of complete examination for UGI and small bowel.Methods: Patients were prospectively recruited to underwent DS-MCE and EGD within 1 week.All DS-MCE procedures in UGI tract were conducted under the control of both magnet and string.Main outcomes included technical success of DS-MCE,visualization of UGI tract,operation related parameters,maneuverability,diagnostic value,discomfort and safety evaluation.Results:(1)From September 2019 to August 2020,a total of 30 subjects(mean age30.6 years,range 19-65 years;20 man,10 women)were prospectively enrolled,18 of which had gastrointestinal complaints and 22 of which demanded and received small-bowel examination after UGI examination.(2)All participants(100%)were performed for successful repeated observation in esophagus,stomach and duodenum,but the detachment of capsule and string by injecting air after UGI examination was failed in one patient,showing that the technical success rate of DS-MCE was 96.7%.(3)DS-MCE provided satisfactory visualization of UGI tract mucosa.Z-line was detected in all 30(100%)participants,with at least two quadrants,three quadrants and four quadrants viewed in 28(93.3%),25(83.3%)and 20(66.7%)participants,respectively.Visualization of gastric mucosa were all assessed as good(≥90%)in all participants.The detection rate of duodenal papilla was 80.0%,and full view of duodenal papilla was captured in 17(56.7%)participants.DS-MCE detected the reverse side of pylorus in 26(86.7%)participants,obtaining a full view in 20(66.7%)participants.And the cleanliness of UGI tract was evaluated as good in most subjects.(4)Among 22 participants,21(95.5%)achieved complete small-bowel examination.(5)Swallowing time and esophageal examination time were 9.5(IQR,6.0-19.25 s)and 2.42(IQR,1.95-3.00 min),respectively.Gastric examination time and duodenal examination time were 6.24 ± 0.98 min and 12.06 ± 4.71 min,respectively.Pyloric transit time was 44.50(IQR,11.11-82.96 min)and small-bowel transit time was 297.04 ± 68.86 min.(6)More than 80%(24/30)of participants had none or mild discomfort(0 or 1)during DS-MCE procedure,and overall discomfort score of DS-MCE was 1.37(range 0-3)compared to 10 of EGD.(7)Diagnostic accuracy of DS-MCE for esophageal,gastric and duodenal diseases was 100%,96.7% and 86.7%,respectively.There were 4 lesions detected by EGD or DS-MCE alone,and 11 small-bowel findings were detected by DS-MCE.(8)No cases of allergic reaction or injury caused by the string and other adverse events occurred.Conclusions: DS-MCE proved to further optimize the visualization of esophagus,stomach and duodenum with excellent diagnostic capability and tolerance,providing an alternative screening modality for UGI tract and small bowel. |
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