The rescue techniques available for cannulation failure are few in number and have severe limitations. We recently described partial ampullary endoscopic mucosal resection (PA-EMR) as a novel technique for difficult biliary cannulation. We aimed to demonstrate the efficacy and safety of PA-EMR for patients with difficult biliary cannulation in a larger cohort.We conducted a prospective cohort study at our tertiary care referral hospital. We recorded demographic factors, procedure-related characteristics, and adverse event rates in patients with difficult biliary cannulation who underwent PA-EMR.Between June 2021 and June 2022, we performed 1073 consecutive endoscopic retrograde cholangiopancreatography procedures on 962 patients; 40 patients (12 male, 28 female, with a mean age of 68.1 [SD 4] years) had difficult biliary cannulation and underwent PA-EMR. Technical success was 100%, and none of the patients required a second session. None of the patients had an adverse event, and we encountered no 30-day mortality. The most typical indication was bile duct stones (60%; n = 24), followed by periampullary tumors (15%; n = 6). The total procedure time was 923 (range 392-1224) seconds.PA-EMR was an effective and safe rescue technique in patients with difficult biliary cannulation.

Biliary cannulation can be challenging even for expert endoscopists, and rescue techniques are limited. Our objective was to determine the feasibility and safety of partial ampullary endoscopic mucosal resection (PA-EMR), a novel technique for biliary cannulation.

Monocentric, retrospective analysis of a prospectively maintained database in a tertiary referral university hospital. Fourteen patients who required endoscopic retrograde cholangiopancreatography (ERCP) and underwent PA-EMR between January 1, 2020 and January 31, 2021 were included. For biliary cannulation of prominent papillae, PA-EMR was performed using a standard polypectomy snare, alone or in combination with needle-knife sphincterotomy. In patients with non-prominent papilla, the papillary mucosa was elevated with the aid of methylene blue injection before resection and combined with needle-knife fistulotomy when needed. The rate of technical success and adverse events was assessed.

The bile duct cannulation success was 99% in the first attempt and 100% overall with the PA-EMR technique. Only one patient experienced mild bleeding, which spontaneously stopped.

PA-EMR is an effective technique that may be considered as a rescue technique for difficult biliary cannulation in expert hands. Future studies including larger cohorts and comparisons with other techniques are warranted to further confirm the feasibility and safety of this novel technique.

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.

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.

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.

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.

Recently the European Society of Gastrointestinal Endoscopy delivered guidelines on the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) and on the papillary cannulation and sphincterotomy techniques at endoscopic retrograde cholangiopancreatography (ERCP). There are no data concerning current practices in Portugal. The aim of this study was to capture practice patterns of Portuguese pancreaticobiliary endoscopists with special interest in the prevention of PEP and cannulation techniques.

A written survey was distributed to all pancreaticobiliary endoscopists attending the first Portuguese meeting dedicated to ERCP in November 2016. The main outcome measures were: technique used for standard biliary cannulation, use of nonsteroidal anti-inflammatory drugs (NSAIDs) in PEP, attempting prophylactic pancreatic stenting after using pancreatic guidewire (PGW)-assisted biliary cannulation in patients where biliary cannulation was difficult, and use of precut as the first rescue technique when biliary cannulation was difficult.

Completed surveys were collected from 28 of the 32 pancreatobiliary endoscopists attending the meeting (answer rate 87.5%). Biliary cannulation was performed using a guidewire access technique by the majority (77%), usually with a sphincterotome. When cannulation was unsuccessful, precut was the first choice for 70%. NSAIDs were administered routinely for PEP by only 54%; PGW-assisted biliary cannulation was the first choice after failed standard cannulation for a minority of them, and only 27% reported to routinely attempt insertion of a pancreatic stent. High-volume endoscopists (> 150/year) tended to use NSAIDs and to insert a stent in PGW-assisted cannulation less often than low-volume-endoscopists (50 vs. 83.3%, p < 0.01, and 40 vs. 100%, p < 0.01, respectively). Precut was started without prior formal training by more than half of the endoscopists.

There is a pronounced discrepancy between evidence-based guidelines and current clinical practice. This discrepancy is more pronounced in PEP prophylaxis, especially among high-volume endoscopists. Some advanced techniques in ERCP are initiated unsupervised, without any previous formal training.

There is a significant gap between guidelines and routine clinical practice.

Background and study aims  Failure to recognize the right direction and precise incision length during precutting has been reported. To address these concerns, we developed a marking method that places a marking on the cutting endpoint before starting precutting. This preliminary study aimed to assess the effectiveness and safety of precut sphincterotomy using our new marking method. Patients and methods  Between April 2015 and May 2017, 21 patients from our tertiary referral center were included in this study. Precut sphincterotomy using our marking method was employed for difficult common bile duct cannulation cases. Before starting precutting, a marking was placed slightly before the upper margin of the bulge of the papilla in the 11- to 12-o'clock direction as a cutting endpoint by cauterization with a needle knife. Results  Technical success was obtained in all 21 procedures. There were no post-endoscopic retrograde cholangiopancreatography (ERCP) complications except for one mild case of post-ERCP pancreatitis. Conclusion  Our new marking method before precutting enabled precise incision and quick bile duct cannulation without causing severe complications.

BACKGROUND Postoperative pancreatitis is one of the most serious complications in endoscopic retrograde cholangiopancreatography (ERCP). To detect potential risk factors for post-ERCP hyperamylasemia and pancreatitis. MATERIAL AND METHODS We reviewed 1786 ERCP procedures in Zhongnan Hospital of Wuhan University from January 2015 to April 2018. Clinical data were extracted, and the complications after ERCP procedures were re-evaluated. Single- and multiple-variable analyses were conducted to detect the potential risk factors. RESULTS We found that 1786 procedures were applied on 1707 patients; 64 patients (3.58%) developed pancreatitis, while asymptomatic hyperamylasemia occurred in 263 cases (14.73%). In multivariate analysis, pancreatic deep wire pass (odds ratio [OR]: 2.280, 95% CI [confidence interval]: 1.129-4.605, P=0.022), endoscopic metal biliary endoprosthesis (OR: 2.399, 95% CI: 1.120-5.138, P=0.024), operation after liver transplantation (OR: 3.057, 95% CI: 1.110-8.422, P=0.031), and fistulotomy (OR: 3.148, 95% CI: 1.036-9.561, P=0.043) were identified as independent risk factors for post-ERCP pancreatitis. Pancreatic deep wire pass (OR: 1.678, 95% CI: 1.136-2.478, P=0.009), fistulotomy (OR: 2.553, 95% CI: 1.096-5.948, P=0.030), and younger age (OR: 0.990, 95% CI: 0.980-0.999, P=0.037) were identified as independent risk factors for hyperamylasemia. CONCLUSIONS To prevent post-ERCP pancreatitis, it is important to avoid high-risk procedures such as fistulotomy and pancreatic deep wire pass, especially in high-risk patients with liver transplantation. For patients with endoscopic metal biliary endoprosthesis, clinicians should pay more attention to the occurrence of post-ERCP pancreatitis.

Pancreatitis is the most frequent complication due to ERCP. Pancreatic duct stent placement has been described as a preventive measure. There is also evidence pointing towards the preventive effect that early precut may provide.

To determine and compare the cost-effectiveness of an early precut approach versus pancreatic duct stent placement for the prevention of post-ERCP pancreatitis.

This was a multicenter, randomized-controlled pilot study with a cost-effectiveness analysis performed between early precut (group A) and pancreatic duct stent (group B) for the prevention of pancreatitis in high-risk patients. Patients with a difficult biliary cannulation and at least one other risk factor for post-ERCP pancreatitis were enrolled and randomized to one of the treatment arms. Both effectiveness and costs of the procedures and their complications were analyzed and compared.

From November 2011 to November 2013, 101 patients were enrolled; 50 subjects were assigned to group A and 51 to group B. There were no significant differences in terms of baseline characteristics of patients between groups. Two cases of mild pancreatitis were observed in each group. The overall costs were U$ 1,242.6 per patient in group A and U$ 1,606.5 per patient in group B. The cost in group B was 29.3% higher (p < 0.0001).

Early precut showed a better cost-effectiveness profile when compared to pancreatic duct stent placement.

While there are guidelines for appropriate training in ERCP, these are non-existent for needle-knife precut. The aim of this study was: (1) evaluate the experience curve of three endoscopists in needle-knife fistulotomy (NKF); (2) propose a minimum number of NKF procedures to attest proficiency.

Between November 1997 and March 2011, the first 120 consecutive NKF performed by three endoscopists (A, B, and C) were selected (360 patients) from three centers. Each group of 120 patients was chronologically ordered into three subgroups of 40. The main outcomes were: NKF use, NKF success, and post-ERCP adverse events.

The need for NKF did not decrease over time. The NKF success rate in the first attempt for endoscopist A and C in each of the three subgroups was 85 %/85 %, 87.5 %/87.5 %, and 87.5 %/90 %, respectively. Furthermore, both demonstrated a high NKF success in their initial 20 NKFs (85 % and 80 %, respectively). Endoscopist B however presented a different pattern as the success rate initiated at 60 %, then rose to 82.5 % and 85 % for the last group (P = 0.03). Adverse events were mild (28 of the 32 occurrences) with no clear reduction with increased experience.

A skillful endoscopist may expect to master NKF easily with few adverse events. While some endoscopists could begin on their own because of their innate skills, a minimal training is needed for all, as we cannot predict skills in advance. We propose a minimum of 20 NKF precuts to attest a trainee's competence in this procedure.

It is sometimes difficult to incise the dis-tal papillary roof (PR) completely in patients with choledocho-liths and choledochoduodenal fistula (CDF). The Iso-Tome® (MTW-Endoskopie W. Haag KG), which is helpful in prevent-ing electrical leakage, has good orientation capabilities and can be easily placed at the orifice of the CDF or ampulla of Vater (AV). We aimed to evaluate the efficacy of endoscopic sphincterotomy (ES) with the Iso-Tome® for cutting the distal PR.

Between May 2003 and July 2012, 35 pa-tients were analyzed retrospectively. The distal PR was cut downward and/or upward using the Iso-tome® until the pink intrapapillary mucosa was fully exposed. Downward incisions were performed from the opening of the CDF to the orifice of the AV; upward incisions were performed in reverse.

Spontaneous or artificial CDF occurred in four and 31 pa-tients, respectively. The technical and therapeutic success rates were 94.3% (33/35) and 94.3% (33/35), respectively. There was no case of electrical damage to the pink intrapap-illary mucosa. Adverse events occurred in 2.9% (1/35; 1, mild bleeding) of patients.

The new technique of ES with the Iso-tome® is feasible and useful for effectively incising the distal PR in patients with CDF and choledocho-liths. (Gut Liver, 2015;9231-238).

The precut timing during the biliary cannulation algorithm is a subject of controversy. Some studies suggest that early institution of precut is a safe and effective strategy even though the extent to which this approach may affect the duration of the ERCP is seldom addressed.

To assess the success, safety, and procedure duration of an early precut fistulotomy (group A) versus a classic precut strategy after a difficult biliary cannulation (group B).

Single-center, prospective cohort study.

University-affiliated hospital.

A total of 350 patients with a naïve papilla.

Standard biliary cannulation followed by needle-knife fistulotomy (NKF).

Biliary cannulation rate, NKF success, adverse events, and ERCP duration.

The overall cannulation rate was similar, at 96% and 94% for groups A and B, respectively. The adverse event rate was 6.2% and 6.4%, respectively, with pancreatitis as the most frequent adverse event (group A, 3.9%; group B, 5.2%). The mean ERCP duration was, however, significantly shorter in group A, both when biliary cannulation was achieved without precutting (14 minutes vs 25 minutes, P < .001) as well as when biliary cannulation was attempted after NKF (18 minutes vs 31 minutes, P < .0001).

Single-center study design, referral center.

If the endoscopist is experienced in ERCP and precut techniques, an early precut strategy should be the preferred cannulation strategy because this approach is as safe and effective as the late fistulotomy approach and substantially reduces ERCP duration.

OBJECTIVE. Although precut is considered an useful alternative when standard methods of biliary access have failed, there is some controversy about it's safety. The study aim was to evaluate the effectiveness of needle-knife fistulotomy (NKF) after a difficult biliary cannulation and whether common bile duct (CBD) diameter influenced complications. MATERIAL AND METHODS. Between November 2006 and December 2010, a total of 1087 consecutive patients with naive papilla were submitted to endoscopic retrograde cholangiopancreatography (ERCP) for biliary access, in an affiliated university hospital. If the biliary cannulation was unsuccessful after 12-15 min, a NKF was performed. The main outcomes were biliary cannulation rate, NKF success and post-ERCP complications. RESULTS. Biliary cannulation by standard methods was successful in 883 patients (81%). In the remaining 204 patients, NKF was performed and allowed CBD access in 166 (81%), leading to a 96% cannulation rate. A second ERCP was performed in 25 patients, with an NKF success of 90% and an overall biliary cannulation rate of 98%. The post-ERCP complication rate was 7.9% (n = 16) with a 6.4% pancreatitis rate and no deaths. The complication for patients with a CBD ≤ to 4 mm was 13.9% compared with 4.5% in the remaining patients (OR = 3.39, p = 0.024). CONCLUSIONS. NKF is a safe and highly useful method of accessing the CBD in the setting of a difficult biliary cannulation. Despite its safety profile, extra caution is needed when applying NKF to patients with thin bile ducts.

The diagnostic and therapeutic utility of endoscopic retrograde cholangiopancreatography (ERCP) has been well demonstrated for biliary and pancreatic diseases. Biliary access can be allowed by infundibulotomy if failed by using the standard cannulation methods. However, no data are available regarding ERCP-related complications in patients taking antiplatelet agents who are undergoing infundibulotomy. Therefore, we aimed to assess the frequency of ERCP-related complications after infundibulotomy in patients taking antiplatelet agents.

We performed a retrospective study, and enrolled 835 patients who underwent ERCP at Pusan National University Hospital from January 2011 to December 2012. Seventy-two patients had been taking antiplatelet agents prior to the procedure. Patients were classified into two groups according to the utilization of infundibulotomy: 20 patients underwent infundibulotomy (group 1), and 52 patients did not undergo infundibulotomy (group 2). Complications after ERCP were defined as bleeding, post-ERCP pancreatitis, and perforation according to Cotton's criteria.

Between group 1 and 2, there were no significant differences in baseline characteristics. ERCP was successfully performed in all cases. Clinically significant bleeding was observed in one patient in group 1 (5%, 1/20) versus none in group 2. Post-ERCP pancreatitis was observed in 2 patients (10.0%, 2/20) in group 1, and 7 patients (13.5%, 7/52) in group 2 (p=0.691). However, none of these differences were statistically significant. No perforation occurred in both groups.

Considering the low incidence of bleeding after infundibulotomy in patients taking antiplatelet agents, infundibulotomy may be safely performed in this group of patients.

Endoscopic retrograde cholangiopancreatography (ERCP) is performed commonly for therapy. Its role in pancreaticobiliary diagnostic imaging has significantly decreased over time. Despite advances in our knowledge of the risk factors, complications, (especially post-ERCP pancreatitis), remain a significant problem. This review highlights the risk factors as related to the patient, procedure and the endoscopist, and the possible means to prevent complications. The best way to avoid any complication is "to avoid any procedure where the indication is not strong" and especially to refrain from doing diagnostic ERCP when alternate noninvasive imaging such as magnetic resonance cholangiopancreatography is available.

This study aims to assess the impact of upfront double-guidewire technique (DGT) following inadvertent early pancreatic duct (PD) cannulation or biliary cannulation and post-endoscopic retrograde cholangiopancreatography (ERCP) complications. A pilot non-randomized cohort study was performed in patients undergoing ERCP. DGT was utilized in the first 25 patients followed by standard cannulation technique (SCT) in the subsequent 25. A significantly lower PD cannulation rate [median (range)] was noted in the DGT group [1 (0-5) vs. 3 (0-6); p=0.013]; however, the pancreatitis rate was similar [2 (9 %) DGT, 1 (4 %) SCT; p=0.601]. In the SCT group, 15/25 (60 %) required DGT to achieve biliary cannulation. The majority of our cohort proceeding to an SCT following early PD cannulation required a DGT to achieve biliary cannulation. Early DGT resulted in a significant reduction in unintentional pancreatic cannulation but did not translate into a reduction in pancreatitis in our cohort.

Precut sphincterotomy (PCS) is a well-established alternative after repeated unsuccessful attempts of common bile duct (CBD) cannulation using standard catheters and/or guide-wire. Commonly used instruments for precutting are the needle-knife and a modified traction-type sphincterotome. In 1996, a so-called 'baby-sphincterotome' with a preshaped, small-caliber 3 Fr tip was developed, which enables cannulation and precutting in one step.

A clinical evaluation was carried out and the complication rates were determined at a tertiary referral hospital.

Prospective clinical evaluation.

During an 8-year period, a total of 5389 endoscopic retrograde cholangiopancreatographies were performed at our hospital. In total, 1886 patients fulfilled the inclusion criteria for this prospective study. The baby-sphincterotome was used in 345 of 1886 patients (mean age 63.4 ± 16.4 years, 203 women) after five unsuccessful attempts of CBD cannulation using a hydrophilic guide-wire. After two more failed CBD cannulations with the baby-sphincterotome, PCS was performed using the same device.

The success rates of biliary access, postendoscopic retrograde cholangiopancreatography pancreatitis, and bleeding were assessed.

Initially, the success rate of CBD cannulation on using the baby-sphincterotome was 28% (96/345 patients). Postinterventional pancreatitis occurred in two of 96 patients (2%) and minor bleeding occurred during traction-type sphincterotomy in four of 93 patients (4%). In the remaining 249 patients precut with a baby-sphincterotome, CBD cannulation was achieved in 219 cases (88%), although with pancreatitis and severe bleeding in 4% each. In 30 of 249 patients (12%), a second or a third (n=5) intervention was necessary, with a success rate of 73% (22/30 cases) after PCS.

This was a single-centre, uncontrolled study.

The newly developed baby-sphincterotome enables bile duct access in a single session in 91% of the patients when guide-wire cannulation has failed. Direct cannulation was possible in about one-quarter of the patients, whereas PCS with the new device showed a high efficacy and a low complication rate.

The aim of this retrospective study was to evaluate the success rate and complications of three precut techniques of sphincterotomy after failure of conventional techniques of cannulation of common bile duct (CBD).

Between January 2003 and October 2011, 2,903 consecutive ERCPs were performed in patients with naïve major papilla. In 283 patients in whom biliary cannulation was not achieved, precut technique was performed and these patients were included in the study.

A total of 274 patients were included in the final analysis. Needle-knife papillotomy (NKP) was performed in 129 cases (47.1 %), suprapapillary fistulotomy (SPF) in 78 patients (28.5 %), and transpancreatic sphincterotomy (TPS) in 67 cases (24.5 %). No significant difference was observed in the initial and eventual success rate of biliary cannulation between the three groups. Overall, complications occurred in 54 patients (19.7 %), of which 33 (25.6 %) were with NKP, 6 (7.7 %) with SPF and 15 (22.4 %) with TPS, respectively, a difference statistically significant favoring the SPF group (p = 0.006). Post-procedure acute pancreatitis was developed in 27 cases (20.9 %) with NKP, compared to two cases (2.6 %) with SPF and 15 cases (22.4 %) with TPS, a difference statistically significant favoring the SPF group. No difference was observed between the groups with regard to the occurrence of post-procedure hemorrhage and perforation.

The three types of precut sphincterotomy have no different overall CBD cannulation rates; SPF reduces post-ERCP pancreatitis risk.

Needle-knife fistulotomy has commonly been used for overcoming difficult bile duct cannulation. Periampullary diverticula (PAD) can be an impediment to endoscopic retrograde cholangiopancreatography (ERCP) procedures. There are little data on needle-knife fistulotomy in patients with PAD. We evaluated the efficacy and safety of needle-knife fistulotomy between patients with and without PAD.

  Data from December 2005 to October 2010 were reviewed. Patients who underwent needle-knife fistulotomy were divided into the group with PAD and the group without PAD (control group). The technical success and complications were compared.

A total of 3012 ERCP cases were analyzed. Needle-knife fistulotomy was performed in 154 out of 3012 cases (5.1%) with 138 of these patients (89.6%) experiencing successful bile duct cannulation. The overall cannulation success rate was not significantly different between PAD group (n=33) and control group (n =121) (93.9% vs 88.4%; P=0.523). There was no significant difference in pancreatitis, bleeding and perforation between the two groups.

  Needle-knife fistulotomy can be performed effectively and safely in patients with periampullary diverticula and difficult bile duct cannulation.

Precut sphincterotomy (PS) is usually indicated in failed standard biliary cannulation (BC). PS requires experienced endoscopists, and contains significant risk. Double-guidewire (DG) cannulation seems to be easier, and might be useful after failed standard BC. We aimed to compare cannulation time, success rate, and complication rates between the two techniques.

Patients who failed standard BC within 10 min by the expert were defined as truly difficult BC and randomized into both groups. In the DG group, the first guidewire was left in the pancreatic duct, and then a catheter, pre-inserted with another guidewire, was used for the BC. In the PS group, a fistulotomy technique was used.

From June 2008 to October 2009, 534 patients underwent endoscopic retrograde cholangiopancreatography. Forty-four patients (8.2%) who failed standard BC were randomized into the DG group (n = 23) and the PS group (n = 21). Median cannulation times and success rates in the DG and PS groups were 172 versus 394 s (P < 0.001), and 73.9% versus 80.9% (P = 0.724), respectively. The pancreatitis rate and serum amylase at 24 h in the DG and PS groups were 21.7% versus 14.3% (P = 0.701) and 937 versus 195 mg/dL (P = 0.020), respectively. Two from each group developed mild bleeding. No perforation occurred.

In truly difficult BC, the DG technique requires a significant shorter duration for BC, with a comparable success rate to the PS technique. The post-procedure serum amylase level in the DG group was significantly higher, and there was a trend of more pancreatitis.

To evaluate the success and complication rates of early precut papillotomy in difficult biliary cannulations performed by an average endoscopist skilled in ERCP.

We studied 146 consecutive ERCPs during a 27-month period. Precutting was instituted if cannulation failed after 10-15 min. Standard papillotomy was performed in the rest. The analysis was divided into initial period (1st year) and subsequent period (following 15 months).

The success rate of cannulation was 95% (139/146). Standard papillotomy was performed in 103/146 (71%) patients. In the remainder, cannulation was successful after precutting in 36/43 (84%) patients. The complication rate was 10% (8/103 in the standard vs. 7/43 in the precut group, P = 0.14). All complications of the standard group were mild. In the precut group, there were three moderate to severe complications. There were no differences between the two periods.

Precut papillotomy can be an effective and relatively safe procedure when performed by an average endoscopist skilled in ERCP. Although the complication rate of precutting tended to be higher than standard papilotomy, this was reasonable since it increased the success of selective biliary cannulation in 25% of cases. Complication rates did not improve with experience.

There is no clear answer regarding use of precut technique versus conventional method in achieving successful biliary cannulation.

To compare the effectiveness of precut technique with that of conventional biliary cannulation by meta-analysis of available randomized controlled trials (RCTs).

Databases including MEDLINE, EMBASE, Cochrane Library, and Science Citation Index updated to July 2009 were searched. Main outcome measures were success rates of biliary cannulation, incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) complications, and post-ERCP pancreatitis rate. Meta-analysis of these clinical trials was performed.

Six RCTs were included. The primary biliary cannulation rate reported with precut and conventional techniques was 89.3 and 78.1%, respectively. Pooled analysis of all selected studies comparing precut cannulation technique with conventional techniques yielded an odds ratio (OR) of 2.05 [95% confidence interval (CI): 0.64-6.63]. Pooled analysis comparing post-ERCP pancreatitis rates for the precut-cannulation groups with those for the conventional-method groups yielded an rate ratio (RR) of 0.46 (95% CI: 0.23-0.92).

This meta-analysis shows that the precut technique does not increase the primary cannulation rate. However, the technique reduces the risk of post-ERCP pancreatitis compared with conventional technique. Further large, well-performed, randomized controlled studies are needed to confirm these findings.

The aim of this study was to evaluate whether the mucosa-tracking technique is effective for improving precutting-related pancreatitis and the sustained failure of bile duct cannulation in precut papillotomy (PP) with the Iso-Tome (MTW Endoskopie).

From September 2004 to June 2006, PP was performed with the Iso-Tome if biliary cannulation failed by conventional methods for approximately 5 minutes. The pink intrapapillary mucosa (PIPM) exposed by PP was tracked and classified into four groups: fully exposed and oriented to the direction of the bile duct (group A) or the pancreatic duct (group B), partially exposed (group C), or unexposed (group D). The success rate of bile duct cannulation (SRBC), the procedure time required for successful bile duct cannulation (PTBC), and the complications in the first session were compared between the mucosa-exposed groups (MEGs; group A, B, and C) and the mucosa-unexposed group (MUEG; group D).

A total of 59 patients (25 females, 34 males) with a mean age of 65.2 years were enrolled. The MEGs and MUEG comprised 52 (88.1%) and 7 (11.9%) patients, respectively. SRBC in the first session was 86.4% (51/59) in total and 92.3% (48/52) in the MEGs, compared to only 42.9% (3/7) in the MUEG (p=0.005). The mean PTBC in the MEGs and MUEG was 8.7 minutes and 16.3 minutes, respectively (p=0.23). Complications occurred in 6.8% of the patients (4/59; all pancreatitis); there were no differences between the MEGs (5.8%, 3/52) and MUEG (14.3%, 1/7; p=0.41). All four patients with pancreatitis were managed medically.

The mucosa-tracking technique in PP with the Iso-Tome is a feasible and useful method of enhancing SRBC. PIPM is an important endoscopic landmark for successful PP.

To investigate the potential risk factors for endoscopic retrograde cholangiopancreatography (ERCP) complications and to identify whether the risk factors are different for pancreatitis and asymptomatic hyperamylasemia.

Consecutive ERCP procedures were studied at 14 centers in China from May 2006 to April 2007. The complications after the patients' first-only procedures were evaluated. Multivariate analysis based on the first-only procedures was used to identify the risk factors.

A total of 3,178 procedures were performed on 2,691 patients. Overall, complications developed in 213 (7.92%) patients, pancreatitis in 116 (4.31%), and asymptomatic hyperamylasemia in 396 (14.72%). In the multivariate analysis, female gender (adjusted odds ratios (ORs): 1.52, 95% confidence interval (CI): 1.14-2.02, P=0.004), periampullary diverticulum (OR: 2.02, 95% CI: 1.49-2.73, P<0.001), cannulation time >10 min (OR: 1.51, 95% CI: 1.08-2.10, P=0.016), > or =1 pancreatic deep wire pass (OR: 1.80, 95% CI: 1.33-2.42, P<0.001), and needle-knife precut (OR: 2.70, 95% CI: 1.42-5.14, P=0.002) were risk factors for overall complications. Female gender (OR: 1.84, 95% CI: 1.25-2.70, P=0.002), age < or =60 year (OR: 1.59, 95% CI: 1.06-2.39, P=0.025), cannulation time>10 min (OR: 1.76, 95% CI: 1.13-2.74, P=0.012), > or =1 pancreatic deep wire pass (OR: 2.77, 95% CI: 1.79-4.30, P<0.001), and needle-knife precut (OR: 4.34, 95% CI: 1.92-9.79, P<0.001) were risk factors for pancreatitis. Cannulation time>10 min (OR: 1.96, 95% CI: 1.52-2.54, P<0.001), > or =1 pancreatic deep wire pass (OR: 2.24, 95% CI: 1.74-2.89, P<0.001), needle-knife precut (OR: 2.34, 95% CI: 1.32-4.14, P=0.004), and major papilla pancreatic sphincterotomy (OR: 1.71, 95% CI: 1.23-2.37, P=0.001) were risk factors for asymptomatic hyperamylasemia.

Patient-related factors are as important as procedure-related factors in determining high-risk predictors for post-ERCP overall complications and pancreatitis. However, the risk factors for asymptomatic hyperamylasemia may be mostly procedure related.

Although needle-knife precut papillotomy (NKPP) is considered a useful alternative for achieving selective biliary cannulation, controversy remains regarding the technical proficiency needed to perform the procedure and its safety. This study evaluated whether procedural experience with NKPP predicted either successful cannulation or the development of complications.

This study retrospectively investigated 104 patients, out of 589 consecutive patients with native papillary, who underwent NKPP performed by a single endoscopist between October 2002 and July 2006. To demonstrate changes in NKPP, the 104 patients were divided chronologically into two groups according to periods: period A (October 2002 to September 2004) and period B (October 2004 to July 2006).

Of the 104 consecutive patients who underwent NKPP, 41 (41/267, 15%) were treated in period A and 63 (63/322, 20%) in period B. There was no significant difference in the overall success rate between periods A (90%) and B (98%) (p = 0.08). However, the initial success rate was higher in period B (95%) than in period A (80%) (p < 0.05). The complication rates were not significantly different between the two groups (10% vs 16%; p = 0.56). Although all complications involved pancreatitis, severe pancreatitis was not observed.

Whereas the initial success rate for NKPP can increase with procedural experience, the complication rate does not seem to decrease. Furthermore, the need for NKPP does not appear to decrease with increasing endoscopic retrograde cholangiopancreatography (ERCP) experience.

AZD0865 is a gastric acid-suppressing agent that has a rapid onset of action and long duration of effect. This double-blind, randomized, multicenter study investigated the efficacy and safety of AZD0865 in the treatment of patients with nonerosive reflux disease (NERD).

Patients with troublesome heartburn for at least 6 months and no evidence of erosions at endoscopy were randomized to receive AZD0865 (25, 50, or 75 mg/day) or esomeprazole 20 mg/day, for 4 wk. Throughout the treatment period, patients reported the presence and intensity of heartburn and other NERD symptoms twice daily using an electronic diary. Twenty-four-hour ambulatory intraesophageal/intragastric pH monitoring was performed in a subset of patients on day 14.

A total of 1,469 patients were randomized. The median time to sustained absence of heartburn (for 7 consecutive days) was approximately 12 days for all treatment groups and did not differ significantly for any of the AZD0865 doses or compared with esomeprazole. There were no significant differences among treatment groups in the cumulative incidence of sustained absence of heartburn during 4 wk treatment (i.e., 65-70%). The percentage of time for which intragastric pH was greater than 4 was significantly greater for AZD0865 75 mg/day compared with esomeprazole 20 mg (75% vs 60%, P < 0.05). AZD0865 was generally well tolerated although reversible elevations of liver transaminases occurred in some patients receiving the agent.

AZD0865 did not provide clinical benefit over esomeprazole 20 mg in the management of patients with NERD.

There is controversy about the ideal utilization of precut papillotomy in endoscopic retrograde cholangiopancreatography examinations. Almost all reports in the literature concentrate on needle knife precut papillotomy, reporting a wide range of complications. We have used Erlangen precut papillotomy in our institution and our aim was to compare the safety of Erlangen precut papillotomy to standard free cannulation technique. The influence of precutting on the deep biliary cannulation rate was also recorded.

Over a period of 48 months a total of 602 out of 1044 consecutive endoscopic retrograde cholangiopancreatography examinations fulfilled the inclusion criteria. Patients with an intact papilla who required biliary cannulation were screened. The cohort was divided into a nonprecut group (n=481) and a precut group (n=121). The standard technique included free biliary cannulation with a tapered-tip cannula. An Erlangen type papillotome was used for precutting. Complications, success rate of cannulation, and hyperamylasemia were recorded.

Complication rates were similar in the 2 groups (nonprecut 7.1% vs. precut 8.3%, P=0.7). Hyperamylasemia was more common in the precut group (13.3% vs. 31.3%, P<0.001). The final deep biliary cannulation rate after precut papillotomy in cases with problematic cannulation was 98.2%.

Erlangen precut papillotomy results in a high deep biliary cannulation rate with no increased risk of complications when compared to cannulation using standard techniques.

To determine the rates of success and complications of precut biliary sphincterotomy (PBS) based on prior experience and to compare the complication rates between PBS and standard endoscopic sphincterotomy (ES).

A retrospective evaluation of prospectively collected non-randomized data at an academic tertiary referral center. The study included all patients in an eight-year period who underwent PBS and ES by a single endoscopist who had no formal training in PBS. The main outcome measures of the study were success and complications of PBS with a comparison to complications of ES.

A total of 2939 endoscopic retrograde cholangiopancreatographies (ERCPs) were performed during the study period, including 818 (28%) ES and 150 (5%) PBS procedures. Selective biliary cannulation via PBS was successful at the first attempt in 75% of the patients. Cannulation was achieved in an additional 13% of the patients at a subsequent attempt (total 87%). Complication rate from PBS was 45% higher than ES, but did not differ significantly [7% (10/50) vs 5% (38/818), P = 0.29]. None of the complications from PBS was severe. A significant trend towards increasing success existed with regard to the endoscopistos first attempt at precut (P = 0.0393, Cochran-Armitage exact test for trend, Z = -1.7588).

Despite the lack of specific training in this technique, PBS was performed with a high success rate and a complication rate similar to or less than reports from other experienced centers. These results suggest that endoscopic experience and perhaps innate endoscopic skill may play an important role in the outcome of this procedure.

The aim of this prospective study was to evaluate the results and the complications at a tertiary referral center which frequently uses precutting techniques for biliary cannulation. Four hundred seventy patients with naive papilla for whom biliary intervention was planned were included in the study. If the selective cannulation was not achieved after a few trials, precutting sphincterotomy was performed. The results were evaluated for the frequency, success, and complication rates of precutting. Precutting was performed on 238 (50.6%; 117 male, 121 female; mean age, 58.5 +/- 16.2 years) of 470 patients. Total success rate of endoscopic retrograde cholangiopancreatography (ERCP) was 99.2% (236/238). The rate of complications in patients with versus without precutting was 7 (2.9%) versus 3 (1.3%) for pancreatitis, 2 (0.8%) versus 1 (0.4%) for perforation, and 7 (2.9%) versus 3 (1.3%) for bleeding. The differences between the rates were not significant. Early precutting can be preferable in prolonged cannulation trials of therapeutic ERCP.

Pre-cutting techniques have been used to gain biliary access at the expense of an increased complication rate. This may be because of the multiple attempts to achieve cannulation by using standard methods before pre-cutting and causing excess edema and papillary trauma. There are limited data on the early use of pre-cutting techniques.

We performed a prospective study of the early introduction of needle-knife techniques in patients with difficult biliary cannulation. Standard biliary cannulation was attempted with a sphincterotome and a guidewire. If this failed within 10 minutes or if there were more than 5 pancreatic cannulations, the needle-knife technique was used. Either a standard method of pre-cutting (below-upward) from the papillary orifice or the modified technique of pre-cutting (above-downward), stopping short of the papillary orifice, was adopted, as per the discretion of the endoscopist. If pre-cutting failed, the cannulation was reattempted 24 to 48 hours later.

A total of 346 therapeutic biliary ERCP procedures were performed between April and August 2003. Of these, 70 patients (20%) (mean age, 54 years; 38 men) underwent needle-knife pre-cut sphincterotomy (16 with the standard technique). In 58 patients (83%), the procedure was successful with the initial pre-cutting, making the total success at initial ERCP 334/346 (96.5%). Nine patients in whom pre-cut failed, returned for a second-attempt ERCP, with 7 completed successfully. The total success rate of pre-cutting was 65/70 (93%). The overall success rate of biliary cannulation, after two ERCP attempts, was 341/346 (98.5%). Six patients had mild bleeding, and one had mild pancreatitis. There was no difference in these complications between the two types of pre-cut techniques.

The early use of needle knife for difficult biliary cannulation is safe and effective, irrespective of the technique used.

A new papillotome has been developed, an isolated-tip needle-knife papillotome (Iso-Tome) that has a semi-oval-shaped tip of epoxide adhesive to prevent electric leakage from the tip of the incising needle. The coated tip aids in keeping the papillotome tightly in the orifice of the ampulla of Vater and is believed to prevent unintentional deep cuts or perforations. This study was done to evaluate the clinical usefulness of the new papillotome for pre-cut papillotomy.

From June 2003 to November 2003, 115 patients underwent attempted ERCP. If biliary cannulation failed by the conventional method, pre-cut papillotomy was performed by using the Iso-Tome in the direction of the bile duct. After successful bile-duct cannulation, papillotomy was extended for therapeutic procedures, such as stone removal or stent insertion, in the majority of the cases. Post-ERCP complications were classified according to consensus guidelines.

Pre-cut papillotomy with the Iso-Tome was done in 25 patients (21.7% of cases). Protective pancreatic stents were not used. Of these patients, 11 had common bile duct stones, 7 had pancreatitis, 5 had malignancies, one had sphincter of Oddi dysfunction, and one had bile-duct leak. After pre-cut papillotomy with the Iso-Tome, bile-duct cannulation was successfully achieved in 23 of 25 (92%) patients. Complications occurred in 7 of 25 patients (28%) and consisted of mild pancreatitis in 5 (20%), moderate bleeding in one (4%), and biliary pain in one (4%). All 7 patients with complications were managed medically, and there was no death.

In this pilot study, the isolated-tip needle knife was found to be a clinically useful papillotome for pre-cut papillotomy. Further large comparative studies (with and without pancreatic protective stents) are needed to determine improved efficacy and safety compared with standard techniques.

To assess the outcome differences following different precut biliary sphincterotomy needle-knife techniques.

Precut biliary needle-knife sphincterotomy (NKS) allows biliary access when standard cannulation techniques fail. Little comparative data exist on the outcome of precut NKS.

Retrospective comparison of outcome differences of three NKS techniques performed by three pancreaticobiliary endoscopists at a tertiary referral center.

A total of 139 consecutive biliary NKS were performed. In 44 cases (technique A), NKS was performed using a precut fistulotomy technique avoiding the papillary orifice, with pure cutting current, and occasional pancreatic duct (PD) stenting (6 of 44). In 47 cases (technique B), NKS was performed starting from the papillary orifice cutting upward with blended current, and no PD stenting. In 48 cases (technique C), NKS was performed as B but using pure cutting current and frequent PD stenting (15 of 48). NKS was successful in 95.5%, 95.7%, and 89.6% at initial endoscopic retrograde cholangiopancreatography and 100%, 97.8%, and 95.6% after a second endoscopic retrograde cholangiopancreatography. Total complications were not significantly different between the three groups; however, a lower incidence of pancreatitis occurred using technique A compared with techniques B and C (not significant).

NKS techniques result in a high success rate of biliary cannulation with a similar overall complication rate. Avoiding cutting at the papillary orifice may reduce the risk of pancreatitis. When cutting at the papillary orifice, pancreatic duct stenting, pure cutting current, or both may reduce the incidence of pancreatitis.

Endoscopic papillotomy, introduced in 1973, is now an established endoscopic procedure for treatment of various diseases of the papilla, bile duct, and pancreas. This article describes the use of this technique, the various instruments that can be employed, the instances in which it is indicated, and its associated complications and risks. Alternative treatments are also summarized.