Success Rate Of Biliary Cannulation Research Articles

Precut Over a Pancreatic Duct Stent Versus Transpancreatic Precut Sphincterotomy for Difficult Biliary Cannulation in Endoscopic Retrograde Cholangiopancreatography: A Retrospective Cohort Study.

Precut over a pancreatic duct stent (PPDS) and transpancreatic precut sphincterotomy (TPS) with immediate pancreatic duct stent placement are techniques employed to promote biliary access during endoscopic retrograde cholangiopancreatography (ERCP) in cases of challenging biliary cannulation. However, limited data are available to compare the efficacy of these two pancreatic stent-assisted precut sphincterotomy techniques. The aim of this study was to compare the efficacy of PPDS versus TPS. A retrospective analysis was performed on the clinical data of consecutive patients who underwent ERCP between April 1, 2019 and May 31, 2023. According to the selected cannulation approaches, patients were assigned to two groups. In the PPDS group, a pancreatic duct stent was initially placed, followed by needle-knife precut over the stent. In the TPS group, transpancreatic precut sphincterotomy was initially performed, followed by immediate pancreatic stent placement. The success rate of biliary cannulation and the incidence of post-ERCP pancreatitis (PEP) between the two groups were analysed. Among 864 patients who underwent ERCP, 46 patients were equally enrolled in the two groups. Selective bile duct cannulation was successfully achieved in 42 out of 46 (91.3%) cases using the PPDS and in 32 out of 46 (69.6%) cases using TPS technique alone, indicating significantly higher success rate of bile duct cannulation with PPDS compared to TPS (91.3% vs. 69.6%, P = 0.009). The overall success rates for bile duct cannulation were 93.5% and 97.8% in the PPDS and TPS groups, respectively, with no significant difference identified (P = 0.307). PEP occurred in 0 and 4 (8.7%) cases in the PPDS and TPS groups, respectively, with no significant difference between the two groups (8.7% vs. 0%, P = 0.117). There were no cases of bleeding or perforation in either group. Both PPDS and TPS followed by immediate pancreatic duct stent placement are viable options. TPS stands out for its simplicity and cost-effectiveness, while PPDS is more appropriate for patients who are at a high-risk of developing PEP.

Needle-Knife Fistulotomy Versus Needle-Knife Papillotomy in Difficult Biliary Cannulation: A Systematic Review and Meta-Analysis.

Endoscopic retrograde cholangiopancreatography (ERCP) is an essential endoscopic therapeutic modality for biliary and pancreatic diseases. Needle-knife fistulotomy (NKF) and papillotomy (NKP) are the two most commonly used rescue techniques for patients with difficult biliary cannulation. However, there remains a need for comparative studies on these approaches to inform clinical decision-making. This meta-analysis aimed to evaluate the efficacy and safety of NKF compared to NKP as a rescue technique in difficult biliary cannulation after failed conventional ERCP. We searched PubMed, Scopus, Embase, and Web of Science databases through November 2023 to include all studies that directly compared the outcomes of NKF with NKP in difficult biliary cannulation. Single-arm studies were excluded. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) for dichotomous data related to clinical events were calculated using the Mantel-Haenszel method within a random-effect model. The primary outcome was the biliary cannulation success rate. Four studies with 823 patients (n = 376 NKF vs. n = 447 NKP) were included in our analysis. There was no significant difference between the two groups in biliary cannulation success rate (91.7% vs. 86.9%, respectively; OR = 1.54, 95% CI: 0.21 - 2.49, P = 0.14; I2 = 0%). However, the overall rate of adverse events was significantly lower in the NKF group than in the NKP group (OR = 0.46, 95% CI: 0.25 - 0.84, P = 0.01). Pancreatitis (OR = 0.23, 95% CI: 0.05 - 1.11, P = 0.07) and bleeding (OR = 1.43, 95% CI: 0.59 - 3.46, P = 0.42) were similar between the two groups. No significant differences in cholangitis, cholecystitis, perforation, or mortality were observed. Our meta-analysis indicates comparable success rates in comparing NKF and NKP techniques for difficult biliary cannulation after failed conventional ERCP cannulation. Notably, the NKF technique significantly reduces overall adverse events compared to NKP, suggesting that NKF may be preferable due to its favorable safety profile. Additional randomized controlled trials (RCTs) are warranted to evaluate the interval benefit of an NKF technique.

Transpancreatic Sphincterotomy After Double Guidewire Technique Was Noninferior to Primary Transpancreatic Sphincterotomy in Difficult Biliary Cannulation.

When unintentional pancreatic duct access occurs during difficult biliary cannulation, the double guidewire (DGW) or transpancreatic sphincterotomy (TPS) may be utilized. DGW can be easily switched to TPS due to the existing guidewire in the pancreatic duct. However, the efficacy of TPS after DGW, named sequential DGW-TPS technique, versus primary TPS has not been assessed. Our aim was to compare the benefits and adverse events of sequential DGW-TPS technique and primary TPS. We performed a comparative retrospective cohort study that enrolled a total of 117 patients with native papillae. The patients were divided into one of 2 groups according to the primary bile duct access technique (sequential DGW-TPS or primary TPS), both with pancreatic stenting. Between November 2017 and May 2023, a total of 84 patients were grouped into sequential DGW-TPS and 33 into primary TPS. The overall post-ERCP pancreatitis (PEP) rate was 4.3% in the entire cohort, with no statistical differences were observed between the groups in terms of PEP rates (P = 0.927), PEP severity (P = 1.000), first biliary cannulation success (P = 0.621), overall cannulation success (P = 1.000), hyperamylasemia incidence (P = 0.241), elevated amylase levels (P = 0.881), and postoperative hospital stay (P = 0.185). Furthermore, these results remained consistent in multivariable regression analysis. The sequential DGW-TPS technique showed a comparable safety and biliary cannulation success rate to primary TPS in difficult biliary cannulation. Given the potential long-term complications associated with TPS, DGW should be first if inadvertent pancreatic access occurs, with TPS serving as second only if DGW fails.

Efficacy of texture and color enhancement imaging for short-type single-balloon enteroscopy-assisted biliary cannulation in patients with Roux-en-Y gastrectomy: Multicenter study (with video).

Texture and color enhancement imaging (TXI) reportedly improves the identification of the papilla of Vater for selective biliary cannulation compared with white light imaging (WLI). This multicenter study evaluated the efficacy of short-type single-balloon enteroscopy (SBE)-assisted biliary cannulation using a new-generation image-enhanced endoscopy processing system equipped with TXI in patients who underwent Roux-en-Y gastrectomy. Patients with Roux-en-Y gastrectomy with a native papilla, and underwent short SBE-assisted biliary cannulation during endoscopic retrograde cholangiopancreatography-related procedures between January 2019 and April 2023 were retrospectively reviewed. Outcomes of biliary cannulation using TXI and WLI were compared. The primary outcome was time to successful biliary cannulation. Thirty-three patients underwent biliary cannulation with TXI and 98 underwent WLI. The biliary cannulation success rates and median time to successful biliary cannulation with TXI and WLI were 93.9% (95% confidence interval [CI] 79.8-99.3%) and 83.7% (95% CI 74.8-90.4%), respectively (P = 0.14), and 10 min (interquartile range [IQR] 2.5-23.5) and 18 min (IQR 9.75-24), respectively (P = 0.04). Biliary cannulation with TXI required a shorter cannulation time than that required withWLI. Adverse event rates with TXI and WLI did not differsignificantly (P = 0.58). Multivariate linear regression analysis showed that the use of TXI and short length of oral protrusion were associated with a shorter successful biliary cannulation time. Short SBE-assisted biliary cannulation was effective and safe on TXI in patients who underwent Roux-en-Y gastrectomy, and achieved shorter successful biliary cannulation time.

The Usefulness of the Alpha-Retroflex Position in Biliary Cannulation on Single-Balloon Enteroscopy-Assisted Endoscopic Retrograde Cholangiopancreatography in Patients with Roux-en-Y Gastrectomy: A Retrospective Study.

Balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography (BE-ERCP) is a useful therapeutic procedure that provides promising results in patients with surgically altered anatomy. However, biliary cannulation in BE-ERCP remains challenging. Therefore, in patients with Roux-en-Y gastrectomy, this study aimed to evaluate a BE-ERCP cannulation strategy that includes the newly developed alpha-retroflex scope position. This was a retrospective review of 52 patients with Roux-en-Y gastrectomy who underwent BE-ERCP at two centers between April 2017 and December 2022. In these patients, three types of scope position had been used for biliary cannulation: straight (S-position), J-retroflex (J-position), and alpha-retroflex (A-position). First, the S-position was used for biliary cannulation. Then, if biliary cannulation was difficult with this position, the J-position was used, followed by the A-position, if necessary. The biliary cannulation success rate was 96.6% (50/52). The S-, J-, and A-positions achieved successful biliary cannulation in 24 (48%), 14 (28%), and 12 patients (24%), respectively. No adverse events, including post-ERCP pancreatitis and perforation, occurred. This was the first study of a cannulation strategy that included the A-position in addition to the S- and J-positions. The study showed that the A-position is feasible and safe in BE-ERCP in patients with Roux-en-Y gastrectomy.

Safety and feasibility of opening window fistulotomy as a new precutting technique for primary biliary access in endoscopic retrograde cholangiopancreatography.

Post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is the most common and serious complication of endoscopic retrograde cholangiopancreatography. To prevent this event, a unique precutting method, termed opening window fistulotomy, was performed in patients with a large infundibulum as the primary procedure for biliary cannulation, whereby a suprapapillary laid-down H-shaped incision was made without touching the orifice. This study aimed to assess the safety and feasibility of this novel technique. One hundred and ten patients were prospectively enrolled in this study. Patients with a papillary roof size ≥10 mm underwent opening window fistulotomy for primary biliary access. In addition, the incidence of complications and success rate of biliary cannulation were evaluated. The median size of the papillary roof was 6 mm (range, 3-20 mm). Opening window fistulotomy was performed in 30 patients (27.3%), none of whom displayed PEP. Duodenal perforation was recorded in one patient (3.3%), which was resolved by conservative treatment. The cannulation rate was high (96.7%, 29/30 patients). The median duration of biliary access was 8 minutes (range, 3-15 minutes). Opening window fistulotomy demonstrated its feasibility for primary biliary access by achieving great safety with no PEP complications and a high success rate for biliary cannulation.

Guide Wire Selection (Straight vs. Angled) in Endoscopic Retrograde Cholangiopancreatography Using a Normal Contrast Catheter Performed by a Trainee: A Single-Center Prospective Randomized Controlled Cross-Over Study.

Wire-guided cannulation (WGC) during endoscopic retrograde cholangiopancreatography (ERCP) is a selective biliary cannulation technique aimed at improving the successful selective biliary cannulation rate and reducing the rate of post-ERCP pancreatitis (PEP) incidence. This study aimed to evaluate the effectiveness of angled-tip guidewires (AGW) vs. straight-tip guidewires (SGW) for biliary cannulation via WGC by a trainee. We conducted a prospective, single-center, open-labeled, randomized, and controlled trial. Fifty-seven patients were enrolled in this study and assigned randomly to two groups (Group A to S and Group S to A). In this study, we started selective biliary cannulation via WGC with an AGW or an SGW for 7 min. If cannulation was unsuccessful, the other guidewire was used, and cannulation was continued for another 7 min (cross-over method). The selective biliary cannulation success rate over 14 min was significantly higher with an AGW compared with an SGW over 14 min (57.8% vs. 34.3%, p = 0.04) and for the second 7-min segment (36.4% vs. 0%, p = 0.04). No significant difference was found for adverse events such as pancreatitis between the two guidewires. Our results suggest that an AGW is recommended for WGC performed by a trainee.

Scissor-type knife precut in balloon enteroscopy–assisted ERCP for patients with difficult biliary cannulation and surgically altered anatomy (with video)

Balloon enteroscopy-assisted ERCP (BE-ERCP) is useful for treating pancreatobiliary disease in patients with surgically altered anatomy (SAA); however, biliary cannulation, including the precut technique, is often challenging. This study aimed to examine the feasibility of scissor-type knife precutting (SKP) during BE-ERCP in patients with SAA. This retrospective study investigated consecutive patients who underwent BE-ERCP and SKP for difficult biliary cannulation between 2016 and 2021. The study outcomes included the technical success and adverse event rates associated with SKP during BE-ERCP. During the study period, 125 patients with native duodenal papillae underwent BE-ERCP, and the papilla was reached in 116 patients. The success rate of biliary cannulation with the standard cannulation approach alone was 67.2% (78/116), which increased to 77.6% (90/116) with the inclusion of advanced cannulation techniques besides precutting and further improved to 87.9% (102/116) with the addition of needlife precutting. SKP was attempted in 12 patients in whom all other cannulation approaches were difficult or resulted in failure. The technical success rate of SKP was 66.7% (8/12); thus, SKP increased the final success rate of biliary cannulation to 94.8% (110/116). The rate of adverse events associated with SKP was 8.3% (1/12). This is the first study to report the use of the SKP technique for difficult biliary cannulation in patients with SAA, which may serve as a useful option for salvage cannulation during BE-ERCP.

Needle knife fistulotomy in flat and diverticular papillae: Is it time for redemption?

BackgroundEuropean Society of Gastrointestinal Endoscopy (ESGE) recommends needle-knife fistulotomy (NKF) as the preferred precut technique in cases when standard cannulation techniques fail. Despite scarce scientific evidence, flat and diverticular papillae are thought not to be ideal for NKF, as they are associated with poor outcomes. The present study aimed to determine the outcomes of the use of NKF in relation to flat and intradiverticular papillae. MethodsThis prospective multicenter study enrolled consecutive patients, evidencing naïve flat (group A, n = 49) or diverticular papilla (group B, n = 28), who underwent NKF after failure of standard cannulation techniques. Diverticular morphology was subdivided into intradiverticular (group B1, n = 14) and diverticular border papillae (group B2, n = 14), using a previously validated endoscopic classification of the major papilla. The success of biliary cannulation at initial endoscopic retrograde cholangiopancreatography (ERCP), overall biliary cannulation, overall cannulation time, and the rate of adverse events were assessed in the study. ResultsThe initial cannulation rates were 93.9%, 64.3% and 71.4% for group A, B1, and B2, respectively (P = 0.005); overall cannulation rates after a second ERCP were 98.0%, 92.9% and 85.7%, respectively (P = 0.134). Adverse events occurred in 11.7% of patients, with post-ERCP pancreatitis (PEP) being the most common adverse event (10.4%). Although there was a trend towards a higher incidence of PEP in flat papillae, univariate and multivariate analyses did not show any significant relationship between pancreatitis and trainee involvement, papillary morphology, nor overall cannulation time. ConclusionsAlthough flat papillae are associated with high success rates of biliary cannulation using NKF, the rate of PEP is not negligible. NKF is feasible in diverticular papillae, but it is associated with a modest success rate in the initial ERCP.

Efficacy and safety of primary, early and late needle-knife fistulotomy for biliary access

European Society of Gastrointestinal Endoscopy recommends needle-knife fistulotomy (NKF) as the preferred precut technique. However, there is little information on whether NKF performed at different times is associated with different success and adverse event rates. We compared the outcomes of 3 different timings of NKF. This was an observational study conducted at 4 institutions and this was a retrospective analysis of prospectively collected data. We included 330 consecutive patients submitted to NKF attempt for biliary access. Patients were divided into three groups: NKF as an initial procedure for biliary access (group A, n = 121); early NKF defined as after 5 min, 5 attempts, or 2 pancreatic passages (group B, n = 99); and late NKF: after at least 10 min of unsuccessful standard biliary cannulation (group C, n = 110). We assessed the success rate of biliary cannulation at initial ERCP, time to perform NKF until biliary cannulation, overall biliary cannulation rate (second ERCP when initial failure), adverse event rate, and predictors of post-ERCP pancreatitis (PEP). The initial cannulation rate was 98%, 91% and 94% for groups A, B and C respectively, p = 0.08, whereas overall biliary cannulation rate was 100%, 95% and 98%, p = 0.115. The adverse event rate/PEP was 4.1%/2.5%, 7.1%/4% and 10.9%/8.2%, for groups A, B and C respectively, (p = 0.197 and p = 0.190). Median time for creating the fistula was A = 4.0 min, B = 3.2 min, and C = 5.6 min, p < 000.1. Each additional minute spent attempting cannulation increased the odds ratio (OR) for PEP by 1.072, and patients with 3 or more risk factors for pancreatitis had a higher chance of PEP. In conclusion, the timing of NFK does not appear to influence success rates but late NFK is associated with a higher time to create a fistula and an increased risk of pancreatitis. Primary NFK is associated with a high rate of success and a low rate of PEP and deserves additional investigation.

A Prospective Multicenter Randomized Feasibility Trial of Double-guidewire Techniques for Difficult Biliary Cannulation Comparing a New Double-guidewire-supported Sphincterotome (MagicTome) to a Conventional Device.

Objective To evaluate the effectiveness and safety of the double-guidewire technique (DGT) using a new double-guidewire-supported sphincterotome (MagicTome) for patients who required endoscopic retrograde cholangiopancreatography (ERCP) for biliary cannulation. Methods This prospective multicenter randomized feasibility trial involved patients with difficult biliary cannulation at any of the three study sites from June 2017 to October 2018. Patients were assigned to the DGT with MagicTome (MDGT) initially performed group and the conventional DGT (CDGT) initially performed group. The success rates of biliary cannulation by MDGT and CDGT and the ERCP-related complications were evaluated. Results Twenty-eight patients were included in this study. No significant difference was observed in the success rates of first attempts and crossover attempts between the groups (p=0.69 and p=1.00). Furthermore, no significant difference was observed in the success rate of biliary cannulation between MDGT and CDGT (62.5% and 75.0%, respectively; p=0.48). CDGT was successful in two of four patients with malignant biliary obstruction. MDGT was successful in all four patients with malignant biliary obstruction, including the two for whom CDGT was unsuccessful. Post-ERCP pancreatitis occurred in only one MDGT case. Conclusion MDGT is safe for biliary cannulation and can be used in cases where biliary cannulation by CDGT is difficult.

Primary Needle-Knife Sphincterotomy for Biliary Access in Patients at High Risk of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.

Methods Forty patients with one or more risk factors for PEP were prospectively enrolled between June 2018 and November 2019. The cannulation was conducted in all patients using NKS as the primary cannulation technique. Success rate of biliary cannulation, biliary cannulation time, and adverse event rate were assessed. Results Of the 40 patients enrolled, 34 patients underwent primary NKS after the screening. Nine patients had 1 risk factor for PEP, 7 had 2, 8 had 3, 7 had 4, and 3 had 5. The success rate of biliary access by NKS was 94.1% (32/34). The median procedure time for NKS and the total procedure time for stone removal or biliary drainage were 4.1 minutes (range, 0.5-25.2) and 11.3 minutes (range, 3.8–40.4), respectively. Adverse events occurred in two patients (minor bleeding, n = 1; hyperamylasemia, n = 1). No patient experienced PEP or perforation. Conclusion NKS might be feasible as a primary cannulation procedure in patients at high risk of PEP. This trial is registered with KCT0004886 (03/06/2018).

Comparison between transpancreatic sphincterotomy and needle-knife fistulotomy in difficulty biliary access, a retrospective study in Taiwan

BackgroundSelective deep biliary cannulation is the first and the most important step before further biliary therapy. Transpancreatic sphincterotomy (TPS), and needle knife fistulotomy (NKF) were commonly used in patients with difficult cannulation, but few studies compare the outcome between TPS and NKF.MethodsA total of 78 patients who met the criteria of difficult cannulation in the National Taiwan University hospital from October 2015 to October 2017 were retrospectively reviewed. Their baseline demographics, success rate of biliary cannulation, and the rate of adverse events were assessed.Results31 patients and 47 patients underwent TPS and NKF for difficult biliary access, respectively. The characteristics of the 2 groups were similar, but patients in TPS group had more frequent pancreatic duct cannulation. Bile duct cannulation was successful in 23 patients (74.2%) in the TPS group and 39 (83.0%) in the NKF group (P = 0.34). There was no difference between the TPS and NKF in the rate of adverse events, including post-ERCP pancreatitis (PEP) (16.1% vs. 6.4%, p = 0.17), and hemorrhage (3.2% vs. 8.5%, p = 0.35). No perforation occurred.ConclusionsBoth TPS and NKF have good biliary access rate in patient with difficult cannulation. TPS has acceptable successful rate and similar complication rate, compared with NKF.

Su1441 PRIMARY NEEDLE KNIFE SPHINCTEROTOMY FOR BILIARY ACCESS IN SELECTED PATIENTS WITH HIGH RISK FOR POST-ERCP PANCREATITIS: A PROSPECTIVE PRELIMINARY FEASIBILITY STUDY

Needle knife fistulotomy may be useful as the first line of procedure for biliary access to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) based on recent clinical data. We aimed to evaluate the safety, effectiveness, and feasibility of primary needle knife sphincterotomy (NKS) for biliary cannulation in patients with a high risk of PEP. A total of 40 patients who need ERCP using primary NKS for biliary disease in our institution between June 2018 and November 2019 were prospectively enrolled in this study. The procedures were conducted by two expert biliary endoscopists (S.J. and J.S.P.) who had experience of ERCPs. They had one or more of the following risk factors of PEP; young age (<50 years), female gender, normal common bile duct (CBD) diameter (≤9 mm), normal serum total bilirubin level (0.2-1.2 mg/dL), obesity (body mass index: >30), or history of pancreatitis. The success rate of biliary cannulation, time to biliary cannulation, and the occurrence rate of PEP, as well as other post-ERCP complications, were assessed. Of 40 patients enrolled, 34 patients underwent primary NKS. Nine patients had 1 risk factor of PEP, seven had 2, eight had 3, seven had 4, and three had 5. The success rate of CBD cannulation using NKS was 94.1% (32/34). The median time for biliary cannulation was 243 seconds (range, 32-1,514 seconds). None of the patients experienced post-ERCP pancreatitis, cholangitis, and perforation. One case of minor bleeding (2.9%, 1/34) and 1 asymptomatic hyperamylasemia (2.9%, 1/34) occurred. Primary NKS might be safe, effective and feasible for biliary access in patients with high risk for PEP if the procedure is performed by expert hands.

Impact of Hospital Volume and the Experience of Endoscopist on Adverse Events Related to Endoscopic Retrograde Cholangiopancreatography: A Prospective Observational Study.

Background/AimsFew studies have addressed the relationship between the occurrence of adverse events (AEs) in endoscopic retrograde cholangiopancreatography (ERCP) and hospital case volume or endoscopist’s experience with inconsistent results. The aim of our study was to investigate the impact of hospital case volume and endoscopist’s experience on the AEs associated with ERCP and to analyze patient- and procedure-related risk factors for post-ERCP AEs.MethodsFrom January 2015 to December 2015, we prospectively enrolled patients with naïve papilla who underwent ERCP at six centers. Patient- and procedure-related variables were recorded on data collection sheets at the time of and after ERCP.ResultsA total of 1,191 patients (median age, 71 years) were consecutively enrolled. The overall success rate of biliary cannulation was 96.6%. Overall, 244 patients (20.5%) experienced post-ERCP AEs, including pancreatitis (9.0%), bleeding (11.8%), perforation (0.4%), cholangitis (1.2%), and others (0.9%). While post-ERCP pancreatitis (PEP) was more common when the procedure was performed by less experienced endoscopists, bleeding was more common in high-volume centers and by less experienced endoscopists. Multivariate analysis showed that a less experience in ERCP was significantly associated with PEP (odds ratio [OR], 1.630; 95% confidence interval [CI], 1.050 to 2.531; p=0.030) and post-ERCP bleeding (OR, 1.439; 95% CI, 1.003 to 2.062; p=0.048).ConclusionsOur study demonstrated that overall AEs following ERCP were associated with the experience of the endoscopist. To minimize post-ERCP AEs, rigorous training with a sufficient case volume is required, and treatment strategies should be modified according to the endoscopist’s expertise.

Primary Needle-Knife Fistulotomy versus Conventional Cannulation Method in High Risk Cohort of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Multicenter Randomized Controlled Trial

Background: Successful biliary cannulation is a prerequisite and important component of endoscopic retrograde cholangiopancreatography (ERCP), but conventional cannulation methods (CCMs) have a post-ERCP pancreatitis (PEP) rate of 14.1% in patients at high risk for PEP. The aims of this study were to evaluate the effectiveness and safety of needle-knife fistulotomy (NKF), compared with a CCM, when used for primary biliary access in patients at high risk for developing PEP. Methods: A total of 207 patients with one or more risk factors for PEP were prospectively enrolled. The patients were randomly allocated to one of two groups according to the primary biliary cannulation technique (NKF or CCM). We compared biliary cannulation success rates, cannulation and procedure times, and the incidence of adverse events, including PEP, between the groups. Findings: The mean number of PEP risk factors was similar between the groups (NKF, 2.2 ± 1.0; CCM, 2.2 ± 0.9). PEP occurred in eight patients in the CCM group and in no patients in the NKF group (9.2% vs. 0%, p < 0.001). The rates of other complications did not differ between the groups. The biliary cannulation success rate was higher in the NKF group than in the CCM group (97.9% vs. 89.7%, p = 0.005). The mean cannulation time and total procedure time were longer in the NKF group than in the CCM group. Interpretation: NKF is an effective and safe procedure to gain primary biliary access in patients at high risk for developing PEP. Trial registration number: ClinicalTrials.gov, NCT02916199. Funding Statement: The authors state: None. Declaration of Interests: The authors state: None. Ethics Approval Statement: The study was approved by the institutional review boards of each institution (Approval number: 3-2017-0092).

Double Guidewire Technique versus Transpancreatic Sphincterotomy for Difficult Biliary Cannulation

Background: The standard biliary cannulation technique has been reported to fail in approximately 5– 20% of cases so, several supplementary techniques have been recommended to facilitate access to the common bile duct (CBD); Double-guidewire technique (DGT) and transpancreaticsphincterotomy (TPS) are effective method in cases of standard biliary cannulation failure. Objective: To compare the outcomes between DGT and TPS in patients with difficult biliary cannulation regarding the procedure duration, success rate and complications. Patients and Methods: This was a randomized study conducted in Al-Hussein University Hospital, Endoscopy Unit in the period between May, 2016 to October, 2017. A total of 40 patients, who bile duct cannulation was not possible and selective pancreatic duct cannulation was achieved were randomized into DGT (n = 19) and TPS (n = 21) groups. DGT or TPS was done for selective biliary cannulation. We measured the technical success rates of biliary cannulation, median cannulation time, and procedure related complications. Results: The distribution of patients after randomization was balanced, and both groups were comparable in baseline characteristics. There was no significant difference between both groups regarding age and sex distribution, clinical presentation, laboratory findings and sonographic findings. Successful cannulation rate and mean cannulation times in DGT and TPS groups were 94.7% vs 95.2% and 20.1 ± 8.7min vs 21.5 ± 7.8min, P = 0.602, respectively. There was no significant difference between the two groups. Conclusion: When free bile duct cannulation was difficult and selective pancreatic duct cannulation was achieved, DGT and TPS facilitated biliary cannulation and showed similar success rates. However, post-procedure pancreatitis and Cholangitis were significantly higher in the DGT group.

Comparison of efficacy and safety of transpancreatic septotomy, needle-knife fistulotomy or both based on biliary cannulation unintentional pancreatic access and papillary morphology

BackgroundPrecut sphincterotomy has been widely performed to facilitate selective biliary access when standard cannulation attempts failed during endoscopic retrograde cholangiopancreatography (ERCP). However, scarce data are available on different precut techniques for difficult biliary cannulation. This study aimed to evaluate the efficacy and safety of transpancreatic septotomy (TPS), needle-knife fistulotomy (NKF) or both based on the presence of unintentional pancreatic access and papillary morphology. MethodsBetween March 2008 and December 2016, 157 consecutive patients undergoing precutting for an inaccessible bile duct during ERCP were identified. Precut techniques were chosen depending on repetitive inadvertent pancreatic cannulation and the papillary morphology. We retrospectively assessed the rates of cannulation success and procedure-related complications among three groups, namely TPS, NKF, and TPS followed by NKF. ResultsThe baseline characteristics of the three groups were comparable. The overall success rate of biliary cannulation reached 98.1%, including 111 of 113 (98.2%) with TPS, 35 of 36 (97.2%) with NKF and 8 of 8 (100%) with NKF following TPS, without significant difference among groups. The incidences of total complications and post-ERCP pancreatitis were 9.6% and 7.6%, respectively. There was a trend towards less frequent post-ERCP pancreatitis after NKF (0%) compared with 11 cases (9.7%) after TPS and one case (12.5%) after NKF following TPS, but not significantly different (P = 0.07). No severe adverse event occurred during this study period. ConclusionsThe choice of precut techniques by the presence of unintended pancreatic access and the papillary morphology brought about a high success rate without increasing risk in difficult biliary cannulation.

Early precut sphincterotomy does not increase the risk of adverse events for patients with difficult biliary access: A systematic review of randomized clinical trials with meta-analysis and trial sequential analysis.

The present study was conducted to investigate whether early precut sphincterotomy (EPS) itself increases the incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP), bleeding, and perforation, or improves the overall success rates of biliary cannulation. Four electronical databases were searched systematically for randomized controlled trials (RCTs) reporting the incidence of adverse events for difficult biliary access (DBA) between EPS groups and persistent cannulation attempts (PCA). The primary endpoint was the incidence of PEP. Secondary outcomes were the incidence of bleeding and perforation, and the overall success rates of biliary cannulation. The Mantel-Haenszel method was used to pool data on the outcomes into random-effect models. Heterogeneity, sensitivity, and stratified analyses were performed with Review Manager 5.3. Furthermore, we performed trial sequential analysis (TSA) to evaluate the reliability of the primary endpoint and secondary outcomes. Seven RCTs (999 patients with DBA of 10450, 9.5%) were included. The incidence of PEP was significantly lower in EPS groups than PCA (risk ratio [RR] = 0.57, 95% confidence interval [CI] 0.36, 0.92, P = .02). Furthermore, TSA (TSA-adjusted 95% CI 0.30-0.82, P = .0061) and subgroup analysis stratified by the fellow involvement in initial cannulation before randomization, technique of precut, and the definition of DBA confirmed this finding. Success rates of overall cannulation (RR = 1.00, P = .94), bleeding (RR = 1.22, P = .58), and perforation (RR = 1.59, P = .32) were similar in both groups; however, the results of TSA could not confirm these findings. Both the quality and the quantity of evidence supporting, compared with PCA, EPS itself do not increase the risk of PEP for DBA patients. Moreover, subgroup analysis demonstrated that EPS can significantly decrease the risk of PEP when it is performed by qualified staff endoscopists with using needle-knife fistulutomy earlier for patients with DBA.

Wire-guided cannulation over a pancreatic stent method increases the need for needle-knife precutting ın patients with difficult biliary cannulations

Cannulation of the major papilla can be problematic, and selective biliary cannulation may fail in up to 18% of cases. Various techniques, such as double-guidewire technique (DGWT), wire-guided cannulation over a pancreatic stent (WGC-PS), the precut endoscopic sphincterotomy (needle-knife precutting technique (NKP), and transpancreatic septostomy have been used to improve the success rate of biliary cannulation. We conducted a prospective, randomized study in order to compare the biliary cannulation success rates of DGWT and WGC-PS techniques in patients with inadvertent passage of guidewire to the pancreatic duct. A total of 100 patients were included in the study and randomized to DGWT (n= 50) or WGC-PS (n= 50) groups. The primary outcome was successful selective cannulation, defined as deep cannulation with selective injection of radiographic contrast material into the common bile duct within 5 minutes by DGW or WGC-PS techniques without performing precut sphincterotomy. Successful selective cannulation was achieved in 45 patients in the DGWT group (90%) and in 27 patients in the WGC-PS group (54%) (P< .001). Five patients (10%) in the DGWT group and 23 (46%) in the WGC-PS group required NKP for biliary access (P< .001). The overall cannulation rate was 98% for DGWT and 98% for WGC-PS (P= 1.00). In patients with unintentional passage of a guidewire into the pancreatic duct during biliary cannulation attempts, the WGC-PS technique significantly increased the need for NKP compared with DGWT.