| Background:The small bowel can be involved in kinds of diseases.Suspected small-bowel bleeding,accounting for about 5-10%of gastrointestinal bleeding cases,is the main indication for small-bowel investigation in clinical practice.However,due to the anatomic characteristics of the small bowel,such as deep position,great length,tortuous shape and high freeness,the diagnosis and treatment of small-bowel diseases had always been a difficult area in the clinical practice of Gastroenterology.In recent years,different types of balloon-assisted enteroscopy（BAE）have been applied one after another,which makes it possible to achieve direct visualization in the whole small bowel under non-surgical conditions and minimally invasive treatment.Thus,BAE has become the most valuable but also the most difficult technical means for the diagnosis and treatment for small-bowel diseases.Single-balloon enteroscopy（SBE）,widely used in domestic clinical centers,has the advantages of relatively easy use and shorter learning curve than double-balloon enteroscopy（DBE）.However,several studies have shown that the procedure-related variables of SBE,such as the insertion depth and the total eneteroscopy rate（TER）,are significantly lower than those of DBE,which may affect its application to a certain extent.Water exchange（WE）is an endoscopic technique of warm water infusion in lieu of air insufflation to extend the digestive tract in the intubation period.Both domestic and foreign studies have confirmed that WE can not only reduce the pain of colonoscopy,improve the cecal intubation rate in difficult colonoscopy,but also has significant advantages in improving the adenoma detection rate（ADR）so as to reduce the risk of interval colorectal cancer.Therefore,we hypothesized that the application of WE in SBE can improve the TER,improve the diagnosis yield,the treatment and prognosis of suspected small-bowel bleeding.Study aims:1.To establish the operation method of water exchange single-balloon enteroscopy（WE-assisted SBE）,and evaluate its safety and effectiveness of improving the TER;2.To evaluate the effect of WE-assisted SBE on the diagnosis,treatment and prognosis of patients with small-bowel bleeding.Methods:1.First of all,we carried out a retrospective study of SBE in our center.We collected and analyzed the baseline characteristics of patients undergoing enteroscopy in our center,as well as the procedure-related data and clinical manifestations of SBE.Then we established the endoscopic operation method and perioperative standard of WE-assisted enteroscopy according to the process of WE-assisted colonoscopy in a prospective case series.The major data included the insertion depth,total enteroscopy,positive findings and endoscopic treatment.Subsequently,a prospective,single-center,single-blinded,randomized controlled trial was conducted.Patients with attempt at total enteroscopy（ATE）were randomly allocated to undergo WE-assisted（WE group）or carbon dioxide-insufflated enteroscopy（CO2 group）.All patients were planned to undergo both antegrade and retrograde procedures.The primary outcome was the total enteroscopy rate（TER）.Secondary outcomes included maximal insertion depth,positive findings,procedural time and adverse events.2.In the retrospective study and prospective case series,we separately analyzed air-insufflated and WE-assisted SBE in patients with suspected small-bowel bleeding,by comparing their clinical outcomes such as the diagnostic and therapeutic rate.After the completion of the prospective randomized controlled trial,we conducted a follow-up and retrospective analysis of the patients with suspected small-bowel bleeding,by comparing the clinical outcomes of the patients who accepted total enteroscopy and those who did not.The recorded data included the diagnostic rate and therapeutic rate during the endoscopy,and the rebleeding rate after discharge.Results:1.In the retrospective study,314 procedures were performed in 245 patients.The most important indication was suspected small intestinal bleeding,which was in 108 cases（44.1%）.About 85%of the patients were examined by two endoscopists.The positive finding rate was 61.2%,and the therapeutic rate during endoscopy was 8.2%.The case series enrolled 20 patients with suspected small-bowel diseases,of which 16 patients were with ATE.Total enteorscopy was achieved in 12 patients（75%）,including 2 cases by oral-only,1 case by anal-only and the others completed by bilateral procedures.The diagnostic rate was 68.8%,and the therapeutic rate during enteroscopy was 25.0%.A total of 110 patients were included in the single-center randomized controlled trial,i.e 55patients in both the WE group and the control group.There was no significant difference in baseline characteristics between patients of the two groups.TER is the WE group was58.2%（32/55）,significantly higher than 36.4%（20/55）in the control group（p=0.022）.The total insertion depth was 521.2±101.4 cm in the WE group and 481.6±95.2 cm in the control group（p=0.037）.The total insertion time（178.9±45.1 min vs.154.2±27.6 min,p<0.001）and antrgrade insertion time（93.6±25.9 min vs.79.2±20.4 min,p=0.002）in the WE group were longer than those in the control group.No significant difference in insertion time was found between the two groups in the anal route（p=0.135）.There was no significant difference in positive findings and of adverse event rate（1.8%vs.1.8%）between the two groups.Multivariate regression analysis showed that the water exchange method was the only independent factor for higher TER.2.In the first retrospective study,108 patients with suspected small-bowel bleeding were included,with a TER of 9.1%（3/33）.The positive detection rate was 63.9%,and the therapeutic rate during endoscopy was 3.7%.The prospective case series included 9patients with suspected small-bowel bleeding.The TER was 77.8%,of which 3 cases（33.3%）were achieved by oral enteroscopy.A total of 7 cases（77.8%）were diagnosed by endoscopy,of which 2 cases（22.2%）underwent endoscopic hemostasis.A total of 33patients with suspected small-bowel bleeding in the randomized controlled trial were followed up,including 16 patients in the total enteroscopy group and 17 in the incomplete enteroscopy group.The positive diagnostic rates of the two groups were comparable（50.0%vs.58.8%,P=0.611）.clinically significant lesions were not detected in small bowel in six patients（18.2%）.During the follow-up,there was no significant difference in 1-year rebleeding rate（56.3%vs.35.3%,P=0.304）and 5-year rebleeding rate（68.8%vs.41.2%,P=0.296）between the two groups.Conclusions:The application of water exchange method can effectively improve the TER and insertion depth during SBE,and also produces comparable safety with air-insufflated enteroscopy.Water exchange method can significantly improve the TER in patients with suspected small-bowel bleeding.While whether it can reduce the rebleeding rate has not been confirmed,which needs further research and evaluation. |
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