Safety and efficacy of primary precut techniques for biliary cannulation: a systematic review and meta-analysis

Eugene Annor; Nneoma Ubah; Dhaval Save; Ishaan Vohra; Ritu Raj Singh; Dushyant Singh Dahiya; Bhanu Siva Mohan Pinnam; Harishankar Gopakumar

doi:10.5946/ce.2025.110

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Systematic Review and Meta-analysis Safety and efficacy of primary precut techniques for biliary cannulation: a systematic review and meta-analysis: Eugene Annor¹, Nneoma Ubah², Dhaval Save³, Ishaan Vohra^1,3, Ritu Raj Singh⁴, Dushyant Singh Dahiya⁵, Bhanu Siva Mohan Pinnam⁶, Harishankar Gopakumar^1,7; Clinical Endoscopy 2026;59(1):58-66.
DOI: https://doi.org/10.5946/ce.2025.110
Published online: October 10, 2025

¹Department of Internal Medicine, University of Illinois College of Medicine at Peoria, Peoria, IL, USA

²Department of Internal Medicine, Montefiore St. Luke’s Cornwall Hospital, Newburgh, NY, USA

³Department of Gastroenterology, Carle Health Methodist Hospital, Peoria, IL, USA

⁴Department of Gastroenterology and Hepatology, University of Illinois College of Medicine, Peoria, IL, USA

⁵Division of Gastroenterology, Hepatology & Motility, The University of Kansas School of Medicine, Kansas City, KS, USA

⁶Department of Internal Medicine, John H. Stroger, Jr Hospital of Cook County, Chicago, IL, USA

⁷Department of Gastroenterology and Hepatology, OSF St. Joseph Hospital, Bloomington, IL, USA

Correspondence: Eugene Annor Department of Internal Medicine, University of Illinois College of Medicine at Peoria, 530 NE Glen Oak Ave, Peoria, IL 61637, USA E-mail: eug.annor@gmail.com

• Received: April 8, 2025 • Revised: May 20, 2025 • Accepted: June 9, 2025

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Abstract
Graphical abstract
INTRODUCTION
METHODS
RESULTS
DISCUSSION
NOTES
REFERENCES

See letter "Needle-knife precut techniques as the initial approach for biliary cannulation, is the evidence sufficient?".

Abstract

Background/Aims
Biliary cannulation is a critical component of endoscopic retrograde cholangiopancreatography (ERCP). When standard methods fail, needle-knife precut sphincterotomy (NKPS) is commonly employed. This systematic review and meta-analysis evaluated the safety and efficacy of using NKPS as a primary technique.
Methods
Electronic databases were searched for studies published between January 2000 and November 2024 that assessed outcomes of primary precut techniques. “Primary precut” was defined as needle-knife sphincterotomy performed as the initial approach without any prior standard cannulation attempts. Pooled proportions were calculated using random-effects models, and heterogeneity was assessed using the Q-test and the I² statistic.
Results
The mean patient age was 57.95 years (standard deviation [SD], 7.59), and 53.23% were female. The cannulation success rate was 96.50% (95% confidence interval [CI], 94.90–97.60) with no heterogeneity (Q, 7.10; df, 8; I²=0%; p=0.935). The rates of adverse events were as follows: post-ERCP pancreatitis, 1.90% (95% CI, 1.20–3.10; I²=0; p=0.942); bleeding, 2.60% (95% CI, 1.70–4.00, I²=0; p=0.725); cholangitis, 1.50% (95% CI, 0.60–3.60; I²=45.27; p=0.067); and perforation, 0.90% (95% CI, 0.40–1.90; I²=0; p=0.948). The overall adverse event rate was 9.70% (95% CI, 5.70–16.10; I²=83.39; p<0.001).
Conclusions
Primary precut sphincterotomy appears to be an effective and safe technique for biliary cannulation in ERCP. These findings support its consideration as a viable first-line approach in appropriate clinical settings.
Keywords: Biliary cannulation; Endoscopic retrograde cholangiopancreatography; Needle knife; Precut sphincterotomy; Safety

Graphical abstract

INTRODUCTION

Biliary cannulation is a critical step for a successful endoscopic retrograde cholangiopancreatography (ERCP), though it may fail in up to 18% of cases, with rates ranging from 5% to 15% even among experienced endoscopists.¹^,² Varying definitions have been proposed for “difficult cannulation,” often based on cannulation time or the number of attempts.¹^,³ The European Society of Gastrointestinal Endoscopy defines difficult cannulation as more than five contacts with the papilla, more than five minutes spent attempting cannulation after the papilla is visualized, or more than one unintended pancreatic duct cannulation or opacification.³^,⁴ While difficult cannulation is often determined retrospectively, the morphology of the major duodenal papilla—particularly the small, pendulous, or protruding types—may predict cannulation difficulty.⁵ Prolonged manipulation and repeated attempts can increase the risk of post-ERCP pancreatitis (PEP).⁴ Various techniques have been proposed to facilitate successful cannulation when difficulty is anticipated or encountered.¹ These include pancreatic stent placement, pancreatic guidewire-assisted cannulation, and precut techniques.⁶

Needle-knife precut sphincterotomy is the most commonly used technique for difficult biliary cannulation when conventional methods fail.⁷ This procedure includes two approaches, differentiated by the site of incision.⁸ Needle-knife precut papillotomy (NKP) involves an incision at the papillary margin, whereas needle-knife fistulotomy (NKF) involves an incision at the roof of the papilla.⁸ These techniques may be performed during the initial ERCP, thereby reducing the costs and manpower associated with a subsequent procedure.⁷ Precut sphincterotomy reportedly has a success rate as high as 90% on the first attempt and nearly 100% on the second.⁷ However, these techniques require a high level of proficiency and should be performed by experienced ERCP endoscopists.⁸ Additionally, the procedure has been associated with PEP, a complication that can increase both morbidity and mortality.⁷ Because precut sphincterotomy is often performed after multiple failed cannulation attempts, it remains unclear whether the increased risk of PEP is attributable to the procedure itself or to the preceding attempts.⁴

Several studies have evaluated various precut sphincterotomy techniques as salvage options following failed conventional biliary cannulation.⁴^,⁶^,⁷ However, few studies have examined the use of these techniques as the primary approach. The present study evaluates the safety and efficacy of primary precut sphincterotomy techniques for biliary cannulation. In this context, “primary precut” refers to a needle-knife incision performed prior to any attempt at biliary cannulation, rather than following multiple failed attempts as described in previous literature.

METHODS

Literature search

We conducted a comprehensive electronic database search using PubMed, Ovid Medline, Google Scholar, Embase, and ScienceDirect to identify relevant studies published from January 2000 to November 30, 2024. The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The keywords used to streamline the search included “primary precut sphincterotomy,” “biliary cannulation,” “needle-knife sphincterotomy,” “needle-knife papillotomy,” and “needle-knife fistulotomy.” Articles were reviewed based on predefined inclusion and exclusion criteria. Titles and abstracts were screened for these keywords. All selected articles were imported into EndNote, and duplicates were identified and removed. Articles were screened at three levels—title, abstract, and full text—by two independent reviewers (E.A. and H.G.). Additionally, reference lists of included studies were manually searched to identify any eligible articles not captured in the primary search.

Selection criteria

Eligible studies for this meta-analysis included those in which NKP and NKF techniques were used as primary approaches for biliary cannulation. “Primary precut” was defined as needle-knife precut sphincterotomy performed as the initial step in biliary cannulation, without any prior attempts using standard cannulation methods. Studies were excluded if precut sphincterotomy techniques were used as salvage methods following failed standard cannulation. Studies evaluating transpapillary sphincterotomy were also excluded, as this procedure is not considered a pure precut technique; it is performed after cannulation of the pancreatic duct and, therefore, by definition, cannot be classified as “primary.” Case reports, case series, conference abstracts, and narrative reviews were also excluded from the analysis.

Data extraction and quality assessment

After selection based on the eligibility criteria, two investigators (E.A. and H.G.) independently reviewed each article. Data were extracted using Microsoft Excel and included patient characteristics as well as efficacy and safety outcomes. Quality assessment was conducted using the Cochrane Risk of Bias Tool for randomized controlled trials and the Newcastle-Ottawa scale for observational studies. Any disagreements were resolved through discussion with a third reviewer (I.V.).

Outcomes

The primary outcomes were the pooled cannulation success and pooled adverse event rates. Secondary outcomes included ERCP-related adverse events such as PEP, cholangitis, bleeding, and perforation.

Statistical analysis

A meta-analysis was conducted to synthesize data from the included studies. A random-effects model, using the DerSimonian-Laird method, was applied to account for study variability and potential heterogeneity. Pooled estimates and corresponding 95% confidence intervals (CIs) were calculated, with a significance level set at p=0.05. Heterogeneity was assessed using the Cochrane I² statistic. Forest plots were generated to illustrate the individual study effect sizes and the overall pooled estimates. A subgroup analysis was performed to evaluate the rates of PEP, cholangitis, bleeding, and perforation. A random-effects model was also applied to pool the outcome event rates. Statistical analyses were performed using Comprehensive Meta-Analysis software ver. 4 (Biostat Inc.).

RESULTS

The database search yielded 3,127 articles. After applying the inclusion and exclusion criteria, nine studies were eligible for inclusion in the meta-analysis, comprising a total of 911 patients. Of these, five were randomized controlled trials and four were observational studies. All included studies were published in peer-reviewed journals.

The mean patient age was 57.95 years (standard deviation [SD], 7.59), and 53.23% of patients were female. Study characteristics are presented in Table 1.⁹^-¹⁷ Among the nine studies, 873 of 911 participants achieved successful biliary cannulation. The pooled cannulation success rate was 96.50% (95% CI, 94.90–97.60). No heterogeneity was detected, as assessed by the Q-test (Q, 7.10; df, 8; p=0.935) and the I² statistic (I²=0%) (Fig. 1).

Among the 911 participants, 91 adverse events were reported. The pooled adverse event rate was 9.70% (95% CI, 5.70–16.10) (Fig. 2). However, this result demonstrated substantial heterogeneity (Q, 48.19; df, 8; p<0.001; I²=83%). Adverse events attributed to primary precut sphincterotomy techniques—including PEP, bleeding, cholangitis, and perforation—were extracted from the included studies. Subgroup analyses were conducted to evaluate each complication. The highest pooled adverse event rate was for bleeding, at 2.60% (95% CI, 1.70–4.00; I²=0; p=0.725) (Fig. 3). The pooled incidence of PEP was 1.90% (95% CI, 1.20–3.10; I²=0; p=0.942) (Fig. 4). Additional complications included cholangitis, with a pooled rate of 1.50% (95% CI, 0.60–3.60; I²=45.27; p=0.067), and perforation, with a rate of 0.90% (95% CI, 0.40–1.90; I²=0; p=0.948) (Figs. 5, 6).

DISCUSSION

This meta-analysis demonstrates that precut sphincterotomy techniques achieve a pooled success rate exceeding 96% when used as the primary approach for deep biliary cannulation. The overall pooled adverse event rate was less than 10%. Subgroup analyses revealed low incidence rates for specific complications, including PEP, cholangitis, bleeding, and perforation. These findings support the use of precut sphincterotomy techniques as a viable option for primary biliary cannulation.

Previous studies have reported success rates for precut sphincterotomy ranging from 94% to 100%.⁹^-¹⁷ The high success rate observed in our meta-analysis is consistent with these findings. Canena et al.¹³ compared NKF used as a primary approach (initial procedure), early approach (after five minutes or five attempts), and late approach (after at least 10 minutes of unsuccessful cannulation), and reported the highest success rates with primary NKF.¹³ Success rates were as high as 98% after the first attempt, and up to 100% when subsequent attempts were included. Additionally, primary precut sphincterotomy has been compared with rescue precut techniques, with no statistically significant difference reported in cannulation times.¹⁸ This may reflect contributing factors such as operator skill level and comparable procedural complexity between groups. The success of precut sphincterotomy has been associated with multiple factors, including the endoscopist’s experience, anatomical variation, early implementation of the technique, and prophylactic pancreatic stent placement prior to the procedure.¹⁸^-²²

In this pooled analysis, an overall adverse event rate of nearly 10% was observed, which aligns with previous studies reporting comparable complication rates ranging from approximately 6% to 15%.²³^-²⁵ Notably, Canena et al.¹³ reported lower adverse event rates with primary precut sphincterotomy compared with early and late precut sphincterotomy. Cennamo et al.,²³ however, reported no significant difference in complication rates between primary and late precut sphincterotomy. PEP is considered a major complication associated with precut sphincterotomy. However, our study found a pooled PEP rate of less than 2%, which is comparable to—or even lower than—PEP rates reported in earlier studies, estimated to range between 3% and 10%.²⁶ Previous literature has described higher PEP rates following precut sphincterotomy.²⁷^-²⁹ More recent studies, however, have not supported this association. In one study, no statistically significant difference in PEP incidence was found between the precut and non-precut groups.²⁶ Furthermore, delayed initiation of precut sphincterotomy has been identified as a potential risk factor for PEP in several studies.²³^,²⁴^,³⁰ Primary precut sphincterotomy has also been associated with a reduced risk of PEP when performed by experienced endoscopists.³¹ These findings suggest that the risk of PEP may be more closely related to prior manipulations than to the precut sphincterotomy technique itself. Our pooled results further support the conclusion that primary precut sphincterotomy does not appear to increase the risk of PEP.

Other adverse events observed in this study included cholangitis, bleeding, and perforation, although their rates were also low. Bleeding had the highest reported incidence among these complications. Previous studies have reported varying bleeding rates, ranging from as low as 0.3% to nearly 7%.³²^-³⁴ The variability in the definition of bleeding across studies may have influenced these reported rates.³³ Bleeding risk may also be associated with inexperience of the endoscopist, anatomical variation, or post-procedural inflammation resulting from multiple cannulation attempts. Unsuccessful precut sphincterotomy has been reported to increase the risk of adverse events,²⁴ likely due to repetitive trauma at the cannulation site. Additionally, female sex has been associated with an increased risk of adverse events, although the underlying mechanisms remain unclear.²⁴

This study has several notable strengths. First, it includes a larger sample size than individual studies, thereby enhancing statistical power and improving the precision of effect size estimates. Additionally, the absence of heterogeneity in the primary outcome suggests a high degree of consistency among the selected studies, which strengthens the reliability of the findings. However, this study also has limitations. Most importantly, it does not compare primary precut with rescue precut sphincterotomy due to limited data availability. Only one study compared primary precut sphincterotomy with early and late precut sphincterotomy.¹³ As a result, a subgroup analysis to evaluate differences among these techniques could not be performed. Notably, prior studies have suggested that adverse events associated with rescue precut sphincterotomy may result from repeated cannulation attempts, implying that primary precut sphincterotomy may reduce the risk of adverse events.¹³^,²³^,²⁴^,³⁰

Another limitation of this meta-analysis is that only one of the included studies reported variations in success and adverse event rates based on the endoscopists’ level of expertise.¹⁴ Additionally, altered anatomy or prior surgical interventions—factors known to increase cannulation difficulty and procedure time—were neither mentioned nor analyzed in the individual studies. The omission of these clinical and operator-related variables may have led to an overestimation of success rates and limits the generalizability of our findings. Moreover, high heterogeneity was observed in adverse event rates, likely due to inconsistent definitions of clinically significant complications across studies. For instance, one study included fever and pain as adverse events, while others focused exclusively on more clinically meaningful complications. This discrepancy may have disproportionately influenced the pooled event rate. Another important factor not accounted for in this analysis was the type of papilla. Papillary morphology is a known determinant of cannulation difficulty and plays a critical role in decisions to perform precut sphincterotomy.⁴ One study found that precut sphincterotomy was required more frequently in cases involving small (type 2), bulging (type 3), and ridged (type 4) papillae compared with regular (type 1) papillae.³⁵ Papillary type significantly influences the success and safety of precut sphincterotomy. Type 4 papillae are particularly difficult to cannulate and are associated with high failure rates, whereas type 1 and type 2 papillae are generally easier to cannulate and have lower failure rates. Unfortunately, data on papillary morphology were not reported in a format that allowed for subgroup analysis. Future studies incorporating papilla classification could clarify the impact of morphology on the outcomes of primary precut sphincterotomy and enhance comparability across studies. Such data could also inform the development of an algorithmic approach for selecting patients for precut sphincterotomy, thereby improving procedural safety and outcomes.³⁶

In conclusion, primary precut sphincterotomy techniques appear to be effective for achieving biliary cannulation during ERCP. The low incidence of adverse events—including PEP, bleeding, cholangitis, and perforation—supports their utility when performed by experienced endoscopists. These findings suggest that primary precut techniques may serve as a viable alternative for biliary access in select cases with anticipated or encountered cannulation difficulty.

Ethical Statements

Not applicable.

Conflicts of Interest

The authors have no potential conflicts of interest.

Funding

None.

Author Contributions

Conceptualization: EA, HG, IV, DS; Data collection: EA, NU, HG, RRS, DSD, BSMP; Formal analysis: EA, HG; Writing–original draft: all authors; Writing–review & editing: EA, NU, HG.

Fig. 1.

Forest plot showing the pooled cannulation rate of the studies. CI, confidence interval.

Fig. 2.

Forest plot showing the pooled adverse event rate of the studies. CI, confidence interval.

Fig. 3.

Forest plot showing the pooled bleeding rate of the studies. CI, confidence interval.

Fig. 4.

Forest plot showing the pooled post-endoscopic retrograde cholangiopancreatography pancreatitis rate of the studies. CI, confidence interval.

Fig. 5.

Forest plot showing the pooled cholangitis rate of the studies. CI, confidence interval.

Fig. 6.

Forest plot showing the pooled perforation rate of the studies. CI, confidence interval.

Table 1.

Baseline demographics of study participants

Study	Year	Study design	Location	Patient (n)	Age (yr)	Female (n)	Male (n)
Khatibian et al.⁹	2008	RCT	Iran	106	56.6	57	49
Jin et al.¹⁰	2016	Prospective, single arm	Korea	55	51	32	23
Furuya et al.¹¹	2018	RCT	Brazil	51	60.9	33	18
Jang et al.¹²	2020	RCT	multicenter	96	57.8	57	39
Canena et al.¹³	2021	Retrospective	Portugal	121	71.3	62	59
Han et al.¹⁴	2021	Retrospective	Korea	167	65.7	65	102
Sadeghi et al.¹⁵	2024	RCT	Iran	130	59.6	69	61
Park et al.¹⁶	2021	Prospective, single arm	Korea	34	52	24	10
Maharshi et al.¹⁷	2021	RCT	India	151	46.7	86	65

RCT, randomized controlled trial.

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Safety and efficacy of primary precut techniques for biliary cannulation: a systematic review and meta-analysis

Clin Endosc. 2026;59(1):58-66. Published online October 10, 2025

DOI: https://doi.org/10.5946/ce.2025.110

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Safety and efficacy of primary precut techniques for biliary cannulation: a systematic review and meta-analysis

Fig. 1. Forest plot showing the pooled cannulation rate of the studies. CI, confidence interval.

Fig. 2. Forest plot showing the pooled adverse event rate of the studies. CI, confidence interval.

Fig. 3. Forest plot showing the pooled bleeding rate of the studies. CI, confidence interval.

Fig. 4. Forest plot showing the pooled post-endoscopic retrograde cholangiopancreatography pancreatitis rate of the studies. CI, confidence interval.

Fig. 5. Forest plot showing the pooled cholangitis rate of the studies. CI, confidence interval.

Fig. 6. Forest plot showing the pooled perforation rate of the studies. CI, confidence interval.

Graphical abstract

Fig. 1.

Fig. 2.

Fig. 3.

Fig. 4.

Fig. 5.

Fig. 6.

Graphical abstract

Safety and efficacy of primary precut techniques for biliary cannulation: a systematic review and meta-analysis

Study	Year	Study design	Location	Patient (n)	Age (yr)	Female (n)	Male (n)
Khatibian et al.9	2008	RCT	Iran	106	56.6	57	49
Jin et al.10	2016	Prospective, single arm	Korea	55	51	32	23
Furuya et al.11	2018	RCT	Brazil	51	60.9	33	18
Jang et al.12	2020	RCT	multicenter	96	57.8	57	39
Canena et al.13	2021	Retrospective	Portugal	121	71.3	62	59
Han et al.14	2021	Retrospective	Korea	167	65.7	65	102
Sadeghi et al.15	2024	RCT	Iran	130	59.6	69	61
Park et al.16	2021	Prospective, single arm	Korea	34	52	24	10
Maharshi et al.17	2021	RCT	India	151	46.7	86	65

Table 1. Baseline demographics of study participants

RCT, randomized controlled trial.