Impact of duodenal papilla anatomy on needle knife papillotomy safety and efficacy in patients with difficult biliary canulation.

BACKGROUND AND AIMS: Needle-knife papillotomy (NKP) is widely performed when biliary cannulation is difficult during endoscopic retrograde cholangiopancreatography (ERCP). However, its safety and efficacy in different types of duodenal papilla are not clear. PATIENTS AND METHODS: This retrospective study analyzed 217 patients with difficult biliary cannulation who underwent NKP during ERCP procedures from June 2013 to May 2022 in our institution. Patients were classified according to Haraldsson classification type of duodenal papilla: type 1, regular; type 2, small; type 3, protruding or pendulous; and type 4, creased or ridged. Outcome measures were successful biliary cannulation and incidence of adverse events. RESULTS: Haraldsson classification was type 1 in 115 patients, type 2 in 29, type 3 in 52, and type 4 in 21. Biliary cannulation was successful in 166 patients (76.5%) Success rates according to Haraldsson type were as follows: type 1, 74.8%; type 2, 82.8%; type 3, 80.8%; and type 4, 66.7%. The rates did not significantly differ among the types (p = 0.48). Overall incidence of adverse events was 9.22%. Incidence of adverse events did not significantly differ among the types (p = 0.69). CONCLUSIONS: NKP was useful to achieve successful cannulation in patients with difficult biliary cannulation. The rate of successful cannulation and incidence of adverse events were similar among the different types of duodenal papilla.

Clinical benefit of early precut sphincintroterotomy for difficult biliary cannulation during endoscopic retrograde cholangiopancreatography.

OBJECTIVES: A precut procedure is sometimes required for difficult biliary cannulation during endoscopic retrograde cholangiopancreatography (ERCP). However, it is unclear whether the biliary access rate has improved for early precut procedures compared to conventional techniques. This study aimed to identify the benefit of early precut sphincterotomy in cases showing difficult biliary access. METHODS: Between April 2017 and August 2021, consecutive patients who underwent precutting for difficult biliary cannulation were retrospectively enrolled. The outcomes of early (≤ 10 min from start of cannulation) and delayed (> 10 min) precut groups were evaluated. All adverse events were defined according to Cotton criteria. RESULTS: A total of 70 patients were enrolled in this study. The biliary cannulation rate for a first ERCP was significantly higher in the early compared to delayed precut group (95% vs. 73.3%; P = 0.015). A difference in overall cannulation rate between the two groups was not observed (97.5% vs. 83.3%; P > 0.05). Significantly higher rates of prophylactic pancreatic stents were described in the delayed compared to early precut group (36.7% vs. 12.5%; P = 0.009). Significant differences in the frequency of pancreatitis, bleeding, penetration, and perforation were not noted between the two groups. Overall, the success rate was statistically significant between the experienced and less experienced endoscopists (87.2% vs. 63.9%; P = 0.017). CONCLUSIONS: Early precutting within 10 min from the start of cannulation in ERCP is safe and effective in cases with a difficult biliary cannulation, and can improve the biliary cannulation rate.

The success rate of cannulation of needle-knife precut is superior to continuing wire-guided after difficult biliary cannulation with pancreatic stent placement.

BACKGROUND: Difficult biliary cannulation and unintended pancreatic cannulation exist in biliary interventions during endoscopic retrograde cholangiopancreatography. Wire-guided cannulation over a pancreatic stent (PS-WGC) and needle-knife precut over a pancreatic stent (PS-NKP) may facilitate biliary cannulation. This study aimed to compare the outcomes of PS-NKP and PS-WGC following guidewire passage into the pancreatic duct. METHODS: A total of 304 patients who inserted a pancreatic stent and continued cannulation using wire-guided (PS-WGC) or needle-knife precut (PS-NKP) from October 2018 to November 2021 in three centers were ultimately enrolled in this study. The success rate of cannulation and incidence of complications were compared between the two groups. RESULTS: Results of the success rate of cannulation in the PS-NKP (n = 98) group were significantly higher compared with the PS-WGC (n = 206) group (96.9% vs. 89.8%; P < 0.05). The overall adverse events were 10.2% (31/304), and PS-NKP had lower (PEP) rates compared with the PS-WGC (3.1% vs. 10.7%, P < 0.05). CONCLUSION: The PS-NKP group is superior to the PS-WGC group in terms of the effectiveness and safety of continued cannulation. Using needle-knife precut, especially early use, over the pancreatic stent to continue cannulation reduced PEP compared with PS-WGC.

Does early application of needle-knife sphincterotomy (NKS) in patients with difficult biliary cannulation increase the risk of postERCP pancreatitis? A single centre study.

Objective: To determine that early needle-knife sphincterotomy does not increase post-ERCP pancreatitis in patients with difficult biliary cannulation as compared to standard cannulation. Method: This prospective single-centre cohort study was carried out at Pak Emirates Military Hospital from January 2021 to June 2021. Patients requiring ERCP were enrolled in the study (according to inclusion and exclusion criteria) and were subsequently allotted different groups according to the technique used for deep biliary cannulation. Qualitative data was analysed using frequencies and chi square statistics whereas, quantitative data was analysed using mean±SD and one way ANOVA test. Result: The cohort included 114 patients with 52.6% male patients and predominance of relatively younger age group (31-45 years). The most common indication for ERCP was choledocholithiasis (36%) with an overall technical success rate of 96%. Deep cannulation was achieved either through standard cannulation (56%), double guidewire and/or pancreatic stent assisted (10.5%), use of early Needle-Knife Sphincterotomy (19%), NKS as a last resort (3.5%) or Transpancreatic Stenting and/or combined sphincterotomy (6%). Pancreatitis as a complication occurred in 4(3.5%) patients, bleeding in 2(1.8%), on-table desaturation in 2(1.8%) and perforation in 1(0.9%) patient. The occurrence of pancreatitis was only related significantly to inadvertent PD cannulation through univariate and logistic regression analysis whereas, multiple cannulations (>5), gender, age, classification of papilla and the use of early NKS had no impact on pancreatitis or the occurrence of other complications. Conclusion: NKS is an effective and safe modality for deep biliary cannulation and achieving technical success where cannulation is deemed difficult and does not increase the risk of PEP if done by experienced endoscopists in high volume centres.

Biliary Cannulation in Endoscopic Retrograde Cholangiography: How to Tackle the Difficult Papilla.

BACKGROUND: In the setting of a naïve papilla, biliary cannulation is a key step in successfully performing endoscopic retrograde cholangiography. Difficult biliary cannulation (DBC) is associated with an increased risk of post-ERCP pancreatitis and failure of the whole procedure. SUMMARY: Recommendations for biliary cannulation can be divided into (a) measures to reduce the likelihood of a difficult papilla situation a priori and (b) rescue techniques in case the endoscopist is actually facing DBC. (a) Careful inspection of the papillary anatomy and optimizing its accessibility by scope positioning is fundamental. A sphincterotome in combination with a soft-tip hydrophilic guidewire rather than a standard catheter with a standard guidewire should be used in most situations. (b) The most important rescue techniques are needle-knife precut, double-guidewire technique, and transpancreatic sphincterotomy. In few cases, anterograde cannulation techniques are needed. To this regard, the EUS-guided biliary drainage followed by rendezvous is increasingly used as an alternative to percutaneous transhepatic biliary drainage. Key Messages: Biliary cannulation can be accomplished with alternative retrograde or less frequently by salvage anterograde techniques, once conventional direct cannulation attempts have failed. Considering recent favorable data for the early use of transpancreatic sphincterotomy, an adopted version of the 2016 European Society for Gastrointestinal Endoscopy (ESGE) algorithm on biliary cannulation is proposed.

Success and Safety of Needle Knife Papillotomy and Fistulotomy Based on Papillary Anatomy: A Prospective Controlled Trial.

BACKGROUND: Needle knife papillotomy (NKP) and fistulotomy (NKF) are the two most commonly used rescue techniques for patients with difficult biliary cannulation (DBC). Anatomy of the major duodenal papillae (MDP) influences the optimal precut technique for biliary access. However, comparative studies of the success and safety of NKP and NKF based on the anatomy of MDP have been scarce. METHODS: Patients with intact MDPs for therapeutic endoscopic retrograde cholangio-pancreatography (ERCP) in our center were enrolled. Early needle knife precuts were uniformly applied to patients with DBC. Difficult MDPs were classified into one of five types based on their endoscopic anatomy. Each type of MDP was allocated to NKP or NKF treatment. Patients with types 1 and 2 papillae always received NKF, 3 and 4 received NKP, and 5 could receive either. The safety and efficacy were analyzed between NKP and NKF, and among different types of MDPs. RESULTS: A total of 188 out of 1674 patients undergoing ERCP satisfied the criteria for early precutting: 75 patients were assigned to the NKP group and 113 to the NKF group. The total initial success rate of biliary cannulation (ISRBC) of the precut techniques (both NKP and NKF) for patients with DBC was 91.5%. The ISRBC of patients of the NKP group was similar to that of the NKF group (90.7% vs 92.0%, P > 0.05). The ISRBC of the patients in the swollen MDP subgroup (96.1%) was higher than that of patients in the distorted MDP subgroup (81.8%, P = 0.030). The total and specific complications of the patients of the NKP group were similar to those of the NKF group (P > 0.05). CONCLUSIONS: NKP and NKF, as selected on the basis of MDP anatomy, are equally safe and highly efficient for patients with DBC to allow biliary cannulation. Patients with swollen MDPs had a higher ISRBC than patients with distorted MDPs. Selecting a precut method based on MDP anatomy is an effective and safe strategy for patients with DBC.

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

BACKGROUND: European 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. METHODS: This 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. RESULTS: The 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. CONCLUSIONS: Although 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.

Outcomes of single-endoscopist-performed needle-knife fistulotomy for selective biliary access in 842 consecutive patients: learning curve and changes over a 14-year period in a retrospective study.

BACKGROUND AND AIMS: Needle-knife fistulotomy (NKF) has emerged as the preferred precut technique. From a late strategy, NKF has shifted to an early rescue technique and has been used recently as a primary method for biliary access. It is unknown how these changes have affected NKF outcomes. We analyzed the outcomes of NKF over time in a large cohort of patients. METHODS: Multicenter retrospective cohort study of 842 patients who underwent NKF for biliary access between 2006 and 2019. Patients were divided into four study periods according to a late or early cannulation strategy and to the use of post-ERCP pancreatitis prophylaxis (Period 1-Period 4). We assessed outcomes of NKF, learning curves and shifts over time. RESULTS: Bile duct access was obtained in 88.0% of the patients. The initial cannulation rate increased significantly from 77.5% in P1 to 92.0% in P4 (p < .001). An endoscopist can obtain 80% success rate after performing 100 NKF procedures (95% CI: 0.79-0.86) and a 95% success rate after 830 procedures (95% CI: 0.92-0.98). Adverse events and pancreatitis were observed in 6.5% and 4.9% of patients respectively. The rate of pancreatitis was not significantly different during the 4 periods (p = .190). A decline in the pancreatitis rate was observed from 2006 until 2016 (no trainees) and then an increase until 2019 (trainees involved). The presence of trainees increased the rate of pancreatitis in the last period by 9.9%. CONCLUSIONS: The success of NKF has increased significantly over the years, initially in a rapid manner and then more slowly. It is associated with a low rate of complications, which tend to decrease with experience. The involvement of trainees is associated with an increased rate of pancreatitis.

Efficacy of drug and endoscopic treatment of Crohn's disease strictures: A systematic review.

BACKGROUND AND AIMS: Strictures are the commonest complication in Crohn's disease. Surgery and endoscopic dilation are the mainstays of treatment, while drug therapy has often been considered contraindicated. The benefit of nonsurgical treatments, particularly drug and endoscopic therapy, need to be defined. METHODS: Ovid MEDLINE, Embase, Emcare, PsycINFO, CINAHL and the Cochrane Library (inception until August 30, 2019) were searched. Studies with ≥ 10 patients with Crohn's disease strictures, reporting on outcomes following medication or endoscopic treatment, were included. RESULTS: Of 3480 records, 85 studies met inclusion criteria and formed the basis of this analysis. Twenty-five studies assessed drug therapy; none were randomized trials. Despite study heterogeneity anti-tumor necrosis factor (TNF) therapy appeared effective, with 50% of patients avoiding surgery after 4 years of follow up. No other drug therapy was of demonstrable benefit. Sixty studies assessed endoscopic therapy including 56 on endoscopic balloon dilation, two assessed needle knife stricturotomy, and two stent insertion. Dilation was equally effective for de novo and anastomotic strictures ≤ 5 cm in length, with most studies reporting a subsequent surgical rate of 30% to 50%. Repeat dilation was required in approximately half of all patients. CONCLUSIONS: Anti-TNF drug therapy and endoscopic balloon dilation are effective strategies for avoiding surgery in patients with stricturing Crohn's disease. Additional endoscopic therapies require further evaluation. Early data suggest that combining these therapies may provide greater benefit than individual therapies. Optimization of current drug and endoscopic therapy, and the incorporation of newer therapies, are needed for stricturing Crohn's disease.

Cannulation procedure optimization for patients with duodenal papillary tumors.

BACKGROUND: The goal of this study was to compare the efficacy and safety of needle-knife fistulotomy (NKF) to that of conventional cannulation methods (CCMs) when used for primary biliary access in patients with duodenal papillary tumors. METHODS: Consecutive patients who had duodenal papillary tumors and who underwent endoscopic retrograde cholangiopancreatography (ERCP) were retrospectively enrolled. Successful cannulation rates, cannulation and procedure times, and the prevalence of adverse events were compared between the NKF and CCM groups. RESULTS: A total of 404 patients (NKF, n = 124; CCM, n = 280) with duodenal papillary tumors were included. The primary and overall cannulation rates were 92.1% (372/404) and 96.0% (388/404), respectively. Compared to CCMs, NKF was associated with a significantly higher successful cannulation rate (99.2% versus 88.9%, P < 0.001) and significantly lower cannulation times (2.1 ± 2.0 min versus 4.7 ± 5.2 min), procedure times (8.8 ± 3.8 min versus 12.9 ± 7.6 min), and unintentional pancreatic duct cannulation rates (1.6% versus 20%), with P < 0.001 for all. Overall adverse events occurred less frequently in the NKF group (3.2% versus 10.7%, P = 0.011). Of these adverse events, post-ERCP pancreatitis (PEP) was significantly lower in the NKF group than in the CCM group (1.6% versus 6.8%, P = 0.03). Bleeding and cholangitis rarely occurred with either cannulation method (0.8% versus 2.1%, P = 0.681, and 0.8% versus 1.7%, P = 0.671, respectively). CONCLUSION: NKF is a more effective and safer procedure than CCMs for patients with duodenal papillary tumors.

Bipolar-current needle-knife with a water jet function (Jet B-knife) shortens the procedure time of endoscopic submucosal dissection for colorectal tumors.

BACKGROUND: Endoscopic submucosal dissection (ESD) is a technically difficult and time-consuming procedure for the treatment of large colorectal tumors. In Japan, the ball-tip bipolar-current needle-knife (BB-knife) has been used in ESD as a safe device that minimizes the damage to deeper tissues of colorectal neoplasms. In May 2012, a BB-knife combined with a water jet function (Jet B-knife) was newly developed. METHODS: This retrospective study was aimed at examining the effectiveness and safety of the Jet B-knife. The BB-knife was used in 276 lesions (BB-knife group), while the Jet B-knife was used in 245 lesions (Jet B-knife group). We evaluated tumor characteristics and the results of the ESD procedures, including the size of the resected tumor, histological diagnosis, time required for resection, frequency of using other electrical devices, en bloc resection rate, and incidence rate of associated complications. Then, the data obtained were compared between the two groups. RESULTS: The histological evaluation of the resected tumors revealed that the incidence of cancer was not significantly different between the two groups. The median time required for resection was 103 min (45-255) in the BB-knife group and 51 min (28-210) in the Jet B-knife group. The difference was statistically significant (p < 0.05). Furthermore, the median tumor diameters were 23.1 mm (18-50) and 26.2 mm (20-60) in the BB-knife and Jet B-knife groups, respectively, demonstrating a statistically significant difference (p < 0.05). Multivariate logistic regression analysis revealed that short resection time (p < 0.001) and reduced use of hemostatic devices (p < 0.01) were independent favorable features of Jet B-knife. The en bloc resection rate and the perforation rate were not statistically significant between the two groups. CONCLUSIONS: Use of the Jet B-knife may contribute to the development of a time-saving, cost-effective, and safe procedure for ESD of colorectal tumors.

Goff Septotomy Is a Safe and Effective Salvage Biliary Access Technique Following Failed Cannulation at ERCP.

BACKGROUND: Biliary cannulation is readily achieved in > 85% of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). When standard cannulation techniques fail, salvage techniques utilized include the needle knife precut, double wire technique, and Goff septotomy. METHODS: Records of patients undergoing ERCP from 2005 to 2016 were retrospectively examined using a prospectively maintained endoscopy database. Patients requiring salvage techniques for biliary access were analyzed together with a control sample of 20 randomly selected index ERCPs per study year. Demographic and clinical variables including indications for ERCP, cannulation rates, and adverse events were collected. RESULTS: A total of 7984 patients underwent ERCP from 2005 to 2016. Biliary cannulation was successful in 94.9% of control index ERCPs, 87.2% of patients who underwent Goff septotomy (significantly higher than for all other salvage techniques, p ≤ 0.001), 74.5% of patients in the double wire group and 69.6% of patients in the needle knife precut group. Adverse event rates were similar in the Goff septotomy (4.1%) and index ERCP control sample (2.7%) groups. Adverse events were significantly higher in the needle knife group (27.2%) compared with all other groups. CONCLUSIONS: This study represents the largest study to date of Goff septotomy as a salvage biliary access technique. It confirms the efficacy of Goff septotomy and indicates a safety profile similar to standard cannulation techniques and superior to the widely employed needle knife precut sphincterotomy. Our safety and efficacy data suggest that Goff septotomy should be considered as the primary salvage approach for failed cannulation, with needle knife sphincterotomy restricted to Goff septotomy failures.

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

BACKGROUND: Selective 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. METHODS: A 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. RESULTS: 31 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. CONCLUSIONS: Both 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.

The effects of small-needle-knife therapy on pain and mobility from knee osteoarthritis: a pilot randomized-controlled study.

OBJECTIVE: To investigate the effect of small needle-knife therapy in people with painful knee osteoarthritis. DESIGN: Pilot randomised, controlled trial. SETTING: Rehabilitation hospital. SUBJECTS: In-patients with osteo-arthritis of the knee. INTERVENTIONS: Either 1 to 3 small needle-knife treatments over seven days or oral Celecoxib. All patients stayed in hospital three weeks, receiving the same mobility-focused rehabilitation. MEASURES: Oxford Knee Score (OKS), gait speed and kinematics were recorded at baseline, at three weeks (discharge) and at three-months (OKS only). Withdrawal from the study, and adverse events associated with the small needle knife therapy were recorded. RESULTS: 83 patients were randomized: 44 into the control group, of whom 10 were lost by three weeks and 12 at 3 months; 39 into the experimental group of whom eight were lost at three weeks and three months. The mean (SE) OKS scores at baseline were Control 35.86 (1.05), Exp 38.38 (0.99); at three weeks 26.64 (0.97) and 21.94 (1.23); and at three months 25.83 (0.91) and 20.48 (1.14) The mean (SE) gait speed at baseline was 1.07 (0.03) m/sec (Control) and 0.98 (0.03), and at three weeks was 1.14 (0.03) and 1.12 (0.03) (P < 0.05). Linear mixed model statistical analysis showed that the improvements in the experimental group were statistically significant for total OKS score at discharge and three months. CONCLUSIONS: Small needle-knife therapy added to standard therapy for patients with knee osteoarthritis, was acceptable, safe and reduced pain and improved global function on the Oxford Knee Score. Further research is warranted.

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

BACKGROUND: Precut 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. METHODS: Between 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. RESULTS: The 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. CONCLUSIONS: The 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.

Application of Electrocautery Needle Knife Combined with Balloon Dilatation versus Balloon Dilatation in the Treatment of Tracheal Fibrotic Scar Stenosis.

BACKGROUND: Electrocautery needle knives can largely reduce scar and granulation tissue hyperplasia and play an important role in treating patients with benign stricture. OBJECTIVE: The aim of this retrospective study was to evaluate the efficacy and safety of electrocautery needle knife combined with balloon dilatation versus balloon dilatation alone in the treatment of tracheal stenosis caused by tracheal intubation or tracheotomy. METHODS: We retrospectively analysed the clinical data of 43 patients with tracheal stenosis caused by tracheotomy or tracheal intubation in our department from January 2013 to January 2016. Among these 43 patients, 23 had simple web-like stenosis and 20 had complex steno sis. All patients were treated under general anaesthesia, and the treatment methods were (1) balloon dilatation alone, (2) needle knife excision of fibrotic tissue combined with balloon dilatation, and (3) needle knife radial incision of fibrotic tissue combined with balloon dilatation. RESULTS: After treatment the symptoms, such as shortness of breath, were markedly improved immediately in all cases. The stenosis degree of patients who were treated with the elec-trocautery needle knife combined with balloon dilatation had better improvement compared with that of those treated with balloon dilatation treatment alone after 3 months (0.45 ± 0.04 vs. 0.67 ± 0.05, p < 0.01), and the proportion of restenosis occurrence that required further treatment was decreased at 6 months (46.9 vs. 81.8%), especially for the web-like stenosis patients, as most of their stenoses dilated with no obvious restenosis and achieved clinical cure. CONCLUSION: Electrocautery needle knife combined with balloon dilatation is an effective and safe treatment for tracheal fibrotic stenosis compared with balloon dilatation alone.

Optimal timing for a second ERCP after failure of initial biliary cannulation following precut sphincterotomy: an analysis of experience at two tertiary centers.

BACKGROUND AND STUDY AIMS: Precut sphincterotomy increases the success of deep biliary cannulation, but the method fails at the initial ERCP in 5-12% of cases. Although other invasive strategies are often used to access the bile duct, a second ERCP may be effective and safe. We evaluated the efficacy, safety, and factors related to a second ERCP after failed cannulation using a precut sphincterotomy. PATIENTS AND METHODS: We reviewed all patients that underwent an ERCP with native papilla from 2006 to 2014 at two tertiary institutions. Efficacy was based on the cannulation rate of the second ERCP, and safety was assessed in terms of adverse events. RESULTS: We identified 112 patients with failed cannulation after precut, and a second ERCP was performed in 72 (64.3%). Median time between procedures was 7 days (IQR 5-11). Deep cannulation was achieved in 54 cases (75%). The only factor associated with cannulation failure was an ERCP within 4 days after the initial precut (cannulation success 44.4 vs. 79.4% after 4 days, p = 0.026). Adverse events were recorded after the first ERCP in 13 of 112 patients (11.8%): delayed bleeding in four, pancreatitis in five, and perforation in four. After the second ERCP, three of 72 patients (4.2%) presented adverse events: two delayed bleeding and one pancreatitis. CONCLUSIONS: A second ERCP after failure of initial biliary cannulation following precut appears to be safe and effective. A second ERCP should be delayed at least 4 days if feasible.

Difficult cannulation as defined by a prospective study of the Scandinavian Association for Digestive Endoscopy (SADE) in 907 ERCPs.

BACKGROUND: The definition of a "difficult" cannulation varies considerably in reports of endoscopic retrograde cholangiopancreatography (ERCP). AIMS: To define a difficult cannulation, which translates into higher risk of post-ERCP pancreatitis. PATIENTS AND METHODS: Prospective consecutive recording of 907 cannulations in Scandinavian centers done by experienced endoscopists. Inclusion: indication for biliary access in patients with intact papilla. Exclusion: acute non-biliary and chronic pancreatitis at time of procedure. RESULTS: The primary cannulation succeeded in 74.9%, with median values for time 0.88 min (53 s), with two attempts and with zero pancreatic passages or injections. The overall cannulation success was 97.4% and post-ERCP pancreatitis (PEP) rate was 5.3%. The median time for all successful cannulations was 1.55 min (range 0.02-94.2). If the primary cannulation succeeded, the pancreatitis rate was 2.8%; after secondary methods, it rose to 11.5%. Procedures lasting less than 5 min had a PEP rate of 2.6% versus 11.8% in those lasting longer. With one attempt, the PEP rate was 0.6%, with two 3.1%, with three to four 6.1%, and with five and more 11.9%. With one accidental pancreatic guide-wire passage, the risk of the PEP was 3.7%, and with two passages, it was 13.1%. CONCLUSIONS: If the increasing rate of PEP is taken as defining factor, the wire-guided cannulation of a native papilla can be considered difficult after 5 min, five attempts, and two pancreatic guide-wire passages when any of those limits is exceeded.

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

Background: 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. Methods: 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. Results: 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. Conclusions: 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.