Prospective randomized controlled trial of water exchange plus cap versus water exchange colonoscopy in unsedated veterans.

BACKGROUND AND AIMS: Water exchange (WE) and cap-assisted colonoscopy separately have been shown to reduce pain during insertion in unsedated patients. We hypothesized that compared with WE, WE cap-assisted colonoscopy (WECAC) could significantly lower real-time maximum insertion pain (RTMIP). METHODS: Veterans without escort were recruited, randomized, blinded, and examined at 3 U.S. Veterans Affairs sites. The primary outcome was RTMIP, defined as the highest segmental pain (0 = no pain, 10 = most severe pain) during insertion. RESULTS: Randomization (WECAC, 143; WE, 137) produced an even distribution of a racially diverse group of men and women of low socioeconomic status. The intention-to-treat analysis reported results of WECAC and WE for cecal intubation (93% and 94.2%, respectively), mean RTMIP (2.9 [standard deviation {SD}, 2.5] and 2.6 [SD, 2.4]), proportion of patients with no pain (28.7% and 27.7%), mean insertion time (18.6 minutes [SD, 15.6] and 18.8 minutes [SD, 15.9]), and overall adenoma detection rate (48.3% and 55.1%); all P values were >.05. When RTMIP was binarized as "no pain" (0) versus "some pain" (1-10) or "low pain" (0-7) versus "high pain" (8-10), different significant predictors of RTMIP were identified. CONCLUSIONS: Unsedated colonoscopy was appropriate for unescorted veterans. WE alone was sufficient. Adding a cap did not reduce RTMIP. Patient-specific factors and application of WE with insertion suction of infused water contributed to high and low RTMIP, respectively. For unescorted patients, selecting those with low anxiety, avoiding low body mass index, history of depression or self-reported poor health, and complying with the steps of WE can minimize RTMIP to ensure success of unsedated colonoscopy. (Clinical trial registration number: NCT03160859.).

Comparison of Right Colon Flat Polyp Detection Rate by Water Exchange Versus Water Immersion-pooled Results of Data File of 3 Published Reports.

GOALS: We tested the hypothesis that water exchange (WE) achieved a significantly higher right colon flat polyp detection rate (rFPDR) than water immersion (WI). BACKGROUND: Current endoscopy methods provide real-time morphology but not histopathology. Flat serrated polyps are difficult to find during colonoscopy. In 2022 2 studies reported that the serrated polyp detection rate (SPDR) significantly inversely predicted the development of interval cancers. In 2021 1 systemic review with meta-analysis showed that WE, but not WI increased SPDR. The relative contributions of WE and WI on rFPDR are unknown. STUDY: Individual patient data from 3 reports comparing air insufflation, WI, and WE were pooled. Multiple logistic regression analysis was used to assess the factors associated with a higher rFPDR. RESULTS: The pooled data showed that the rFPDR of air insufflation, WI, and WE were 15.4%, 14.1%, and 19.4% ( P =0.009), respectively. After adjusting for age and withdrawal time, multiple logistic regression analysis revealed that WE, when compared with WI, was significantly associated with a higher rFPDR (adjusted odds ratio[aOR]=1.53, P =0.002). Analysis of data on pathology and size were omitted to avoid duplicating our earlier publications. CONCLUSIONS: Significantly higher rFPDR was achieved by WE. Water exchange rather than WI merits consideration for use to maximize rFPDR. Removal of flat polyps, and by inference serrated polyps, ensures their optimal management to minimize the occurrence of interval cancers. The potential benefit of WE in maximizing SPDR and minimizing interval cancers deserves evaluation in long-term randomized controlled studies focused on flat polyps detection.

Identification of a novel bile marker clusterin and a public online prediction platform based on deep learning for cholangiocarcinoma.

BACKGROUND: Cholangiocarcinoma (CCA) is a highly aggressive malignant tumor, and its diagnosis is still a challenge. This study aimed to identify a novel bile marker for CCA diagnosis based on proteomics and establish a diagnostic model with deep learning. METHODS: A total of 644 subjects (236 CCA and 408 non-CCA) from two independent centers were divided into discovery, cross-validation, and external validation sets for the study. Candidate bile markers were identified by three proteomics data and validated on 635 clinical humoral specimens and 121 tissue specimens. A diagnostic multi-analyte model containing bile and serum biomarkers was established in cross-validation set by deep learning and validated in an independent external cohort. RESULTS: The results of proteomics analysis and clinical specimen verification showed that bile clusterin (CLU) was significantly higher in CCA body fluids. Based on 376 subjects in the cross-validation set, ROC analysis indicated that bile CLU had a satisfactory diagnostic power (AUC: 0.852, sensitivity: 73.6%, specificity: 90.1%). Building on bile CLU and 63 serum markers, deep learning established a diagnostic model incorporating seven factors (CLU, CA19-9, IBIL, GGT, LDL-C, TG, and TBA), which showed a high diagnostic utility (AUC: 0.947, sensitivity: 90.3%, specificity: 84.9%). External validation in an independent cohort (n = 259) resulted in a similar accuracy for the detection of CCA. Finally, for the convenience of operation, a user-friendly prediction platform was built online for CCA. CONCLUSIONS: This is the largest and most comprehensive study combining bile and serum biomarkers to differentiate CCA. This diagnostic model may potentially be used to detect CCA.

A survey of colonoscopists with and without in-depth knowledge of water-aided colonoscopy.

BACKGROUND AND AIM: Endoscopy featured water-aided colonoscopy (WAC) as novel in the Innovation Forum in 2011. Gastrointestinal Endoscopy published a modified Delphi consensus review (MDCR) that supports WAC for clinical practice in 2021. We tested the hypothesis that experience was an important predictor of WAC use, either as water immersion (WI), water exchange (WE), or a combination of WI and WE. METHODS: A questionnaire was sent by email to the MDCR authors with an in-depth knowledge of WAC. They responded and also invited colleagues and trainees without in-depth knowledge to respond. Logistic regression analysis was used with the reasons for WAC use treated as the primary outcome. Reports related to WAC post MDCR were identified. RESULTS: Of 100 respondents, > 80% indicated willingness to adopt and modify practice to accommodate WAC. Higher adenoma detection rate (ADR) incentivized WE use. Procedure time slots ≤ 30 and > 30 min significantly predicted WI and WE use, respectively. Co-authors of the MDCR were significantly more likely to perform WAC (odds ratio [OR] = 7.5, P = 0.037). Unfamiliarity with (OR = 0.11, P = 0.02) and absence of good experience (OR = 0.019, P = 0.002) were associated with colonoscopists less likely to perform WAC. Reports related to WAC post MDCR revealed overall and right colon WE outcomes continued to improve. Network meta-analyses showed that WE was superior to Cap and Endocuff. On-demand sedation with WE shortened nursing recovery time. CONCLUSIONS: An important predictor of WAC use was experience. Superior outcomes continued to be reported with WE.

Water-assisted colonoscopy: an international modified Delphi review on definitions and practice recommendations.

BACKGROUND AND AIMS: Since 2008, a plethora of research studies has compared the efficacy of water-assisted (aided) colonoscopy (WAC) and underwater resection (UWR) of colorectal lesions with standard colonoscopy. We reviewed and graded the research evidence with potential clinical application. We conducted a modified Delphi consensus among experienced colonoscopists on definitions and practice of water immersion (WI), water exchange (WE), and UWR. METHODS: Major databases were searched to obtain research reports that could potentially shape clinical practice related to WAC and UWR. Pertinent references were graded (Grading of Recommendations, Assessment, Development and Evaluation). Extracted data supporting evidence-based statements were tabulated and provided to respondents. We received responses from 55 (85% surveyed) experienced colonoscopists (37 experts and 18 nonexperts in WAC) from 16 countries in 3 rounds. Voting was conducted anonymously in the second and third round, with ≥80% agreement defined as consensus. We aimed to obtain consensus in all statements. RESULTS: In the first and the second modified Delphi rounds, 20 proposed statements were decreased to 14 and then 11 statements. After the third round, the combined responses from all respondents depicted the consensus in 11 statements (S): definitions of WI (S1) and WE (S2), procedural features (S3-S5), impact on bowel cleanliness (S6), adenoma detection (S7), pain score (S8), and UWR (S9-S11). CONCLUSIONS: The most important consensus statements are that WI and WE are not the same in implementation and outcomes. Because studies that could potentially shape clinical practice of WAC and UWR were chosen for review, this modified Delphi consensus supports recommendations for the use of WAC in clinical practice.

Underwater versus conventional endoscopic resection of nondiminutive nonpedunculated colorectal lesions: a prospective randomized controlled trial (with video).

BACKGROUND AND AIMS: Incomplete resection of colorectal neoplasia decreases the efficacy of colonoscopy. Conventional resection (CR) of polyps, performed in a gas-distended colon, is the current standard, but incomplete resection rates of approximately 2% to 30% for nondiminutive (>5 mm), nonpedunculated lesions are reported. Underwater resection (UR) is a novel technique. The aim of this study was to determine the incomplete resection rates of colorectal lesions removed by UR versus CR. METHODS: In a randomized controlled trial, patients with small (6-9 mm) and large (≥10 mm) nonpedunculated lesions were assigned to CR (gas-distended lumen) or UR (water-filled, gas-excluded lumen). Small lesions in both arms were removed with a dedicated cold snare. For CR, large lesions were removed with a hot snare after submucosal injection. For UR, large lesions were removed with a hot snare without submucosal injection. Four-quadrant biopsy samples around the resection sites were used to evaluate for incomplete resection. RESULTS: Four hundred sixty-two eligible polyps (248 UR vs 214 CR) from 255 patients were removed. Incomplete resection rates for UR and CR were low and did not differ (2% vs 1.9%, P = .91). UR was performed significantly faster for lesions ≥10 mm in size (10-19 mm, 2.9 minutes vs 5.6 minutes, P < .0001); ≥20 mm, 7.3 minutes vs 9.5 minutes, P = .015). CONCLUSIONS: Low incomplete resection rates are achievable with UR and CR. UR is effective and safe with the advantage of faster resection and potential cost savings for removal of larger (≥10 mm) lesions by avoiding submucosal injection. As an added approach, UR has potential to improve the cost-effectiveness of colonoscopy by increasing efficiency and reducing cost while maintaining quality. (Clinical trial registration number: NCT02889679.).

Impact of mechanical simulator practice on clinical ERCP performance by novice surgical trainees: a randomized controlled trial.

BACKGROUND: Lack of forward-viewing endoscopy experience impairs training in endoscopic retrograde cholangiopancreatography (ERCP). We evaluated the effect of ERCP mechanical simulator (EMS) practice on ERCP performance by surgical trainees. PATIENTS AND METHODS: 12 surgical trainees without endoscopy experience were randomly allocated to non-EMS (n = 6) programs or to EMS (n = 6) programs with coaching and 20 hours of supervised EMS practice. All trainees then received supervised hands-on clinical ERCP training. Trainers provided verbal instructions and hands-on assistance, and took over if cannulation was not achieved by 20 minutes. Blinded trainers rated clinical performance. RESULTS: Each group performed 150 clinical ERCPs. Biliary cannulation success was significantly higher in the EMS vs. the non-EMS group (P = 0.006), with shorter mean times (in minutes) for intubation, cannulation, and completion (all P < 0.001). EMS trainees showed a significantly better mean performance score (P = 0.006). In multivariate analysis, after adjusting for case sequence, CBD stone, complexity, and EMS training, the effect of EMS practice on odds for successful cannulation remained highly significant (odds ratio [OR] 2.10 [95 %CI 1.46 - 3.01]). At 6 months EMS trainees still had better cannulation success vs. non-EMS controls (P = 0.045); no difference was observed after 1 year. CONCLUSIONS: EMS practice shortens the ERCP early learning curve of inexperienced surgical trainees, improves clinical success in selective biliary cannulation, and may reduce complications.

Water Exchange (WE) and Quality Improvement-Enhanced Advanced Adenoma Detection: A Pooled Data Analysis of 6 Randomized Controlled Trials.

INTRODUCTION: Advanced adenomas (≥10 mm in diameter, >25% villous, or high-grade dysplasia), a marker of colorectal cancer risk, are used to stratify patients for closer surveillance. Modern accessories, endoscopes, and age-adjusted evaluation have variable impacts on the advanced adenoma detection rate (AADR). In 1 randomized controlled trial (RCT) comparing air insufflation (AI) with water exchange (WE), the right colon AADR was significantly increased by WE. Four network meta-analyses reported that WE significantly increased overall adenoma detection rate (ADR), but the impact on AADR was not addressed. AIM: The aim of this study was to test the hypothesis that WE significantly increased AADR compared with AI. METHOD: Six Clinicaltrial.gov-registered RCTs were reported by a group of WE investigators. Data including AADR (primary outcome) and overall ADR (secondary outcome) were pooled. RESULTS: A total of 5407 patients were randomized to AI (2699) and WE (2708). Compared with AI, WE significantly increased AADR (5.7% vs. 8.3%, P=0.001) and overall ADR (20.9% vs. 27.4%, P=0.001). CONCLUSIONS: In contrast to published reports, which showed variable impacts on AADR, WE was consistent in increasing AADR in 6 reported RCTs. The pooled data confirm that the impact of WE in increasing AADR was significant. The significantly enhanced overall ADR indicated that WE provided a higher quality outcome than AI. The significant improvement in AADR confirmed WE to be clinically relevant and has finally arrived as a timely addition to colorectal cancer prevention programs.

Water Exchange Produces Significantly Higher Adenoma Detection Rate Than Water Immersion: Pooled Data From 2 Multisite Randomized Controlled Trials.

GOALS: To test the hypothesis that water exchange (WE) significantly increases adenoma detection rates (ADR) compared with water immersion (WI). BACKGROUND: Low ADR was linked to increased risk for interval colorectal cancers and related deaths. Two recent randomized controlled trials of head-to-head comparison of WE, WI, and traditional air insufflation (AI) each showed that WE achieved significantly higher ADR than AI, but not WI. The data were pooled from these 2 studies to test the above hypothesis. STUDY: Two trials (5 sites, 14 colonoscopists) that randomized 1875 patients 1:1:1 to AI, WI, or WE were pooled and analyzed with ADR as the primary outcome. RESULTS: The ADR of AI (39.5%) and WI (42.4%) were comparable, significantly lower than that of WE (49.6%) (vs. AI P=0.001; vs. WI P=0.033). WE insertion time was 3 minutes longer than that of AI (P<0.001). WE showed significantly higher detection rate (vs. AI) of the >10 mm advanced adenomas. Right colon combined advanced and sessile serrated ADR of AI (3.4%) and WI (5%) were comparable and were significantly lower than that of WE (8.5%) (vs. AI P<0.001; vs. WI P=0.039). CONCLUSIONS: Compared with AI and WI, the superior ADR of WE offsets the drawback of a significantly longer insertion time. For quality improvement focused on increasing adenoma detection, WE is preferred over WI. The hypothesis that WE could lower the risk of interval colorectal cancers and related deaths should be tested.

Comparable Long-term Outcomes of 1-Minute vs 5-Minute Endoscopic Papillary Balloon Dilation for Bile Duct Stones.

BACKGROUND & AIMS: Endoscopic papillary balloon dilation (EPBD) is an alternative to endoscopic sphincterotomy for choledocholithiasis. Unlike endoscopic sphincterotomy, EPBD preserves biliary sphincter function, reducing long-term risk of recurrent choledocholithiasis by 50%. Guidelines recommend that duration of EPBD exceeds 2 minutes, to adequately loosen the sphincter and reduce risks of failed stone extraction and post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, it is unclear whether this long duration of EPBD impairs sphincter function and negates the long-term benefit of EPBD. We performed a randomized controlled trial to determine whether long-duration (>1 minute) EPBD increases the risk of subsequent choledocholithiasis and hepatobiliary complications compared with short-duration EPBD (<1 minute). METHODS: We performed a prospective study of 170 adult patients who underwent ERCP for suspected choledocholithiasis from April 2007 through October 2008 at 2 centers in Taiwan. Patients were randomly assigned to groups that underwent 1-minute (n = 86) or 5-minute (n = 84) EPBD for choledocholithiasis; patients were followed through June 2015. One month after the initial ERCP, patients were examined and liver function tests and abdominal sonographies were performed. Patients were then examined every 3-6 months over a median follow-up period of approximately 7 years. The primary outcome was recurrent choledocholithiasis or acute cholangitis and the secondary outcome was overall hepatobiliary complications. We assessed the effects of EPBD duration by Cox regression. RESULTS: Thirteen patients (15.1%) developed recurrent choledocholithiasis or acute cholangitis after 1-minute EPBD, and 10 patients (11.9%) developed recurrent choledocholithiasis or acute cholangitis after 5-minute EPBD (P = .352). There was no significant difference between groups in number of hepatobiliary complications (P = .154). Compared with 1-minute EPBD, 5-minute EPBD did not increase risk of the primary outcome (adjusted hazard ratio, 0.76; 95% confidence interval, 0.32-1.82) or the secondary outcome (adjusted hazard ratio, 0.65; 95% confidence interval, 0.31-1.40). Mechanical lithotripsy, performed for failed stone extraction with EPBD at initial ERCP, was a risk factor for primary and secondary outcomes. CONCLUSIONS: In a randomized controlled trial, we found that the risk of recurrent choledocholithiasis and hepatobiliary complications did not increase with long-duration EPBD (>1 minute), but was increased with mechanical lithotripsy.

Impact of water exchange colonoscopy on serum sodium and potassium levels: an observational study.

BACKGROUND: Concerns over the hypothetical adverse effects of water absorption and the disturbance of serum sodium and potassium levels prompted a quality assurance evaluation of water exchange (WE) colonoscopy. AIM: The purpose of this study was to evaluate the balance of water infused and suctioned in WE colonoscopy, and to quantify the acute impact on serum levels of sodium and potassium. METHODS: Prospectively collected quality monitoring data of patients undergoing screening and surveillance colonoscopy at the Sacramento Veterans Affairs Medical Center were analyzed. Measurements were made of volume infused and suctioned during, and blood samples drawn 10 min before the start of and 10 min after completion of WE colonoscopy. Outcome measures included volume of water infused and suctioned, and serum levels of sodium and potassium. RESULTS: A total of 140 patients (134M:6F), mean age of 59, underwent WE colonoscopy. Mean total volume of water infused was 1,839 mL. A negative balance of an average of 22 mL was documented. The mean (standard deviation) values (in meq/L) of serum levels of sodium 139.33 (2.27) and 139.28 (2.32), and potassium 3.86 (0.36) and 3.91 (0.39), before and after colonoscopy, respectively, showed no significant change. CONCLUSION: The WE method allowed most of the water infused during colonoscopy to be recovered by suction at the completion of colonoscopy. Serum sodium and potassium levels did not change significantly within 10 min after completion. The WE method appears to be safe with minimal water retention and is devoid of acute fluctuations in serum levels of sodium and potassium.

Beyond ribosomal function: RPS6 deficiency suppresses cholangiocarcinoma cell growth by disrupting alternative splicing.

Cholangiocarcinoma (CCA) is a bile duct malignancy with a dismal prognosis. This study systematically investigated the role of the ribosomal protein S6 (RPS6) gene, which is dependent in CCA. We found that RPS6 upregulation in CCA tissues was correlated with a poor prognosis. Functional investigations have shown that alterations in RPS6 expression, both gain- and loss-of function could affect the proliferation of CCA cells. In xenograft tumor models, RPS6 overexpression enhances tumorigenicity, whereas RPS6 silencing reduces it. Integration analysis using RNA-seq and proteomics elucidated downstream signaling pathways of RPS6 depletion by affecting the cell cycle, especially DNA replication. Immunoprecipitation followed by mass spectrometry has identified numerous spliceosome complex proteins associated with RPS6. Transcriptomic profiling revealed that RPS6 affects numerous alternative splicing (AS) events, and combined with RNA immunoprecipitation sequencing, revealed that minichromosome maintenance complex component 7 (MCM7) binds to RPS6, which regulates its AS and increases oncogenic activity in CCA. Targeting RPS6 with vivo phosphorodiamidate morpholino oligomer (V-PMO) significantly inhibited the growth of CCA cells, patient-derived organoids, and subcutaneous xenograft tumor. Taken together, the data demonstrate that RPS6 is an oncogenic regulator in CCA and that RPS6-V-PMO could be repositioned as a promising strategy for treating CCA.

Biliary fibrosis is an important but neglected pathological feature in hepatobiliary disorders: from molecular mechanisms to clinical implications.

Fibrosis resulting from pathological repair secondary to recurrent or persistent tissue damage often leads to organ failure and mortality. Biliary fibrosis is a crucial but easily neglected pathological feature in hepatobiliary disorders, which may promote the development and progression of benign and malignant biliary diseases through pathological healing mechanisms secondary to biliary tract injuries. Elucidating the etiology and pathogenesis of biliary fibrosis is beneficial to the prevention and treatment of biliary diseases. In this review, we emphasized the importance of biliary fibrosis in cholangiopathies and summarized the clinical manifestations, epidemiology, and aberrant cellular composition involving the biliary ductules, cholangiocytes, immune system, fibroblasts, and the microbiome. We also focused on pivotal signaling pathways and offered insights into ongoing clinical trials and proposing a strategic approach for managing biliary fibrosis-related cholangiopathies. This review will offer a comprehensive perspective on biliary fibrosis and provide an important reference for future mechanism research and innovative therapy to prevent or reverse fibrosis.

A novel method with significant impact on adenoma detection: combined water-exchange and cap-assisted colonoscopy.

BACKGROUND: Water exchange provides salvage cleansing and improves adenoma detection, but drawbacks include prolonged procedure time. Cap-assisted colonoscopy decreases cecal intubation time but is limited by impaired views when feces lodge in the cap. OBJECTIVE: To investigate the impact of combined water-exchange and cap-assisted colonoscopy (WCC) on detection of adenomas and proximal colon serrated polyps. DESIGN: Retrospective, single-center, single-colonoscopist, consecutive group observational study. SETTING: Veterans Affairs outpatient endoscopy suite. PATIENTS: Outpatients undergoing screening or surveillance colonoscopy. INTERVENTION: WCC data collected from 100 consecutive patients were compared to a control group of 101 consecutive patients examined with conventional air insufflation colonoscopy during the prior 4-month period. MAIN OUTCOME MEASUREMENTS: Adenoma detection rate (ADR), adenomas detected per colonoscopy, proximal colon serrated polyp detection rate, and proximal colon serrated polyps per colonoscopy rate. RESULTS: Compared with controls, the WCC group had a higher polyp detection rate (93.0% vs 84.2%; P = .07), ADR (75.0% vs 59.4%; P = .02), proximal colon ADR (61.0% vs 47.5%; P = .07), proximal colon serrated polyp detection rate (24.0% vs 9.9%; P = .009), number of adenomas per colonoscopy (2.70 vs 1.50; P = .002), and mean number of proximal colon serrated polyps per colonoscopy (0.38 vs 0.12; P = .004). LIMITATIONS: Retrospective study; single, unblinded endoscopist. CONCLUSION: ADR and adenomas per colonoscopy are both sensitive indicators of colonoscopy quality. WCC merges two simple methods to improve the performance of screening and surveillance colonoscopy. The data suggest that larger, prospective studies are necessary to determine if there are differences between water-exchange combined with cap-assisted maneuvers and the individual components used alone in lesion detection in screening and surveillance colonoscopy.

Coached practice using ERCP mechanical simulator improves trainees' ERCP performance: a randomized controlled trial.

BACKGROUND AND STUDY AIMS: Preliminary data suggested that simulation practice using an endoscopic retrograde cholangiopancreatography (ERCP) mechanical simulator (EMS) improved trainees' skill. The aims of the current study were to confirm the impact of coached EMS practice at the beginning of ERCP training and to investigate whether subsequent uncoached EMS practice provides additional benefit. METHODS: Trainees entering ERCP training in 2008 (n = 8) and 2009 (n = 8) at two referral medical centers were randomized to receive a coached EMS practice either with (2009) or without (2008) subsequent uncoached practices or only routine training (controls). The outcome measures were successful deep biliary cannulation by the trainee and overall performance score as rated by blinded trainers, during the subsequent 3 months of clinical practice. RESULTS: Trainees undergoing single and multiple EMS practices were more likely than controls to achieve successful biliary cannulation (single: adjusted odds ratio [aOR] 2.89, 95 % confidence interval [CI] 2.21 - 3.80 [P < 0.001]; multiple: 3.09, 95 %CI 1.13 - 8.46 [P = 0.028]) and to have superior overall performance scores (aOR 3.29, 95 %CI 1.37 - 7.91 [P = 0.008] and 6.92, 95 %CI 3.77 - 12.69 [P < 0.001], respectively). The benefit of single and multiple EMS practices on overall performance score remained significant after adjustment for success or failure of deep biliary cannulation (aOR 2.98, 95 %CI 1.38 - 6.43 [P = 0.005] and 6.09, 95 %CI 2.40 - 15.45 [P < 0.001], respectively). The benefits of single vs. multiple EMS practices were not statistically different. CONCLUSIONS: Coached simulation using EMS improved novice trainees' success of biliary cannulation and overall ERCP performance. Additional uncoached practices did not appear to provide further benefit. Trainees should undergo a coached EMS practice at the beginning of ERCP training.

Saline irrigation for reducing the recurrence of common bile duct stones after lithotripsy: a randomized controlled trial.

Background: Mechanical lithotripsy produces stone fragments that are not easily detected by cholangiography and is a potential cause of recurrence of common bile duct stones (CBDS). This study aims to clarify whether 100 ml saline irrigation after mechanical lithotripsy reduces the recurrent rate of CBDS. Methods: In this randomized controlled trial performed at the Surgical Endoscopy Center, the First Hospital of Lanzhou University between May 10, 2019, and Dec 31, 2020, patients undergoing endoscopic mechanical lithotripsy were randomly assigned to receive saline irrigation (study group) or no irrigation (control group). The saline irrigation was given 100 ml saline pulse irrigation after cholangiography showed no residual stones. Patients were followed up for at least 24 months after endoscopic stone removal to assess the recurrence of CBDS. This study was registered with ClinicalTrials.gov (NCT03937037). Findings: During the median follow-up period of 35.6 months (interquartile range, 26.0-40.7), 43 of the 180 patients had stone recurrence (24%). The frequency of recurrence of CBD stones was 12.22% in the saline irrigation group and 35.56% in the control group, with a difference of 23.33% between the two groups (95% confidence interval [CI], 11.35%-35.32%, p < 0.001). Multivariable Cox proportional hazards analyses showed that constipation (hazard risk [HR] 2.42; 95% CI, 1.22-4.80, p = 0.012), periampullary diverticulum (PAD) (HR 3.06; 95% CI, 1.62-5.79, p < 0.001), and total to direct bilirubin ratio (HR 1.48; 95% CI, 1.21-1.81, p < 0.001) were independent risk factors for the recurrence of CBDS. Saline irrigation was the only preventive factor for the recurrence of CBDS (HR 0.22; 95% CI, 0.11-0.44, p < 0.001). Interpretation: For patients with CBDS requiring mechanical lithotripsy, 100 ml saline irrigation effectively reduces the recurrent rate of CBDS after endoscopic stone removal. Funding: This work was supported by National Natural Science Foundation of China (32160255); Natural Science Foundation of Gansu Province (22JR5RA898, 20JR10RA676); Science and Technology Planning Project of Chengguan District in Lanzhou (2020JSCX0043).