Effect of Precut Sphincterotomy on Biliary Cannulation Based on the Characteristics of the Major Duodenal Papilla

Effect of Precut Sphincterotomy on Biliary Cannulation Based on the Characteristics of the Major Duodenal Papilla

CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2007;5:1113–1118 ENDOSCOPY CORNER Effect of Precut Sphincterotomy on Biliary Cannulation Based on the Charac...

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CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2007;5:1113–1118

ENDOSCOPY CORNER Effect of Precut Sphincterotomy on Biliary Cannulation Based on the Characteristics of the Major Duodenal Papilla AKIRA HORIUCHI,* YOSHIKO NAKAYAMA,‡ MASASHI KAJIYAMA,* and NAOKI TANAKA* *Department of Gastroenterology and ‡Department of Pediatrics, Showa Inan General Hospital, Komagane, Japan

Background & Aims: Therapeutic endoscopic retrograde cholangiopancreatography requires selective cannulation of the relevant ductal system. The aim of this study was to evaluate the efficacy and safety of 3 different precutting techniques for difficult bile duct access on the basis of the characteristics of the major duodenal papilla (MDP). Methods: The patients were classified into small MDP, large MDP, or swollen MDP groups on the basis of the characteristics of the MDP. The precutting technique was based on MDP characteristics: transpancreatic sphincterotomy for small MDPs, needle-knife precut sphincterotomy for large MDPs, and needle-knife fistulotomy for swollen MDPs. The success rate of bile duct cannulation and the complication rates were compared. Results: A total of 86 patients (58 men; mean age, 76 years) with difficult bile duct cannulation required precutting technique; 48 had transpancreatic sphincterotomy, 30 had needle-knife precut sphincterotomy, and 8 had needle-knife fistulotomy. With precutting, the procedure was successful in 46 of 48 (96%), 27 of 30 (90%), and 8 of 8 patients (100%), respectively. The overall success rate of biliary cannulation after 2 endoscopic retrograde cholangiopancreatography attempts was 100%. The overall complication rate was 4.7% (4 of 86) (2 mild bleeding and 2 mild pancreatitis). Conclusions: Selection of the precutting technique on the basis of the characteristics of the MDP resulted in a high degree of success and a low complication rate in cases of difficult bile duct cannulation.

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herapeutic endoscopic retrograde cholangiopancreatography (ERCP) requires selective cannulation of the relevant ductal system. However, the appropriate duct cannot be cannulated in 5%–20% of cases, and the use of various precutting techniques has been proposed to overcome difficult situations and to result in a higher overall success rate.1 Although precut sphincterotomy has been used for many years and is considered a useful alternative for achieving selective bile duct cannulation, there is still controversy regarding its safety because complications such as pancreatitis, perforation, and bleeding are reportedly higher (6%–34%) with precut techniques compared with standard cannulation techniques.1 The most frequently used precutting method is the needleknife sphincterotomy in which an incision is made starting at the orifice and extending cephalad for a variable distance.2,3 A variation of the needle-knife technique is referred to as needle-

knife fistulotomy and involves making a puncture into the papilla above the orifice and then cutting either upward in a cephalad direction or downward toward the orifice.4 Another approach to precutting involves use of a traction sphincterotome, originally described with a specialized short-nosed sphincterotome, wedged into the common channel in the direction of the bile duct. A variation of that technique involves intentional seating of the tip of a standard traction sphincterotome into the pancreatic duct and cutting through the septum in the direction of the bile duct. This is often referred to as transpancreatic sphincterotomy.5,6 Although the usefulness of needle-knife sphincterotomy, needle-knife fistulotomy, and transpancreatic sphincterotomy has been previously compared,7,8 there is no report regarding the choice of the technique in relation to the characteristics of the major duodenal papilla (MDP). This retrospective study examined the outcome of needle-knife sphincterotomy, needleknife fistulotomy, or transpancreatic sphincterotomy on the basis of the characteristics of the MDP in terms of cannulation success and complication rates.

Patients and Methods Patients Between January 2000 –December 2005, 1062 patients underwent ERCP. The bile duct was deemed inaccessible if attempts at routine cannulation were unsuccessful after more than 15 minutes and/or the pancreatic duct had been injected/ opacified multiple times. The endoscopist was permitted to use a guidewire to achieve bile duct cannulation. As a result, 98 consecutive patients with inaccessible bile ducts underwent sphincterotomy (done by 1 of 2 staff endoscopists, A.H. or M.K.). Twelve patients who had undergone gastrectomy with Billroth II anastomosis were excluded. The outcomes of 86 patients were evaluated retrospectively. At the initial attempt, transpancreatic sphincterotomy, needle-knife sphincterotomy, or needle-knife fistulotomy was prospectively chosen on the basis of the characteristics of the MDP. When the initial attempt with needle-knife sphincterotomy was unsucAbbreviations used in this paper: ERCP, endoscopic retrograde cholangiopancreatography; MDP, major duodenal papilla; NKF, needle knife fistulotomy; NKS, needle knife sphincterotomy; TPS, transpancreatic sphincterotomy. © 2007 by the AGA Institute 1542-3565/07/$32.00 doi:10.1016/j.cgh.2007.05.014

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Figure 1. Endoscopic views of an MDP. (A) A small MDP; (B) a large MDP; (C) a swollen MDP. The papilla without orad protrusion was recognized as a small MDP, whereas the papilla with orad protrusion was considered to be a large MDP. The papilla with the marked swelling of orad protrusion was defined as a swollen MDP. In this case the border between the papilla and orad protrusion was indistinct.

cessful, transpancreatic sphincterotomy was used. If both procedures and transpancreatic sphincterotomy alone failed, the procedure was repeated in 48 –72 hours (if excessively edematous), or the precutting was extended, and cannulation was reattempted. Patients were monitored as inpatients for complications. Complications were assessed according to consensus criteria.9 Informed consent was obtained from all patients.

Classification of Type of Major Duodenal Papilla The MDP was classified into small, large, or swollen (Figure 1). The definitions were as follows: a small MPD was a papilla without orad protrusion, a large MDP was a papilla with

orad protrusion, and a swollen MDP was a papilla with marked swelling of orad protrusion in which the border between the papilla and orad protrusion was indistinct.

Precutting Techniques A precut sphincterotome (KD-6Q-1, KD-V411M-0725; Olympus, Tokyo, Japan) or a needle-knife sphincterotome (KD10Q-1; Olympus) was used. The transpancreatic sphincterotomy was performed as follows: the tip of a standard “tractiontype” sphincterotome initially was inserted into the pancreatic duct, and a sphincterotomy was performed with pure-cut electrosurgical current. The incision was directed toward the 11o’clock position and through the septum to completely unroof the papilla (Figure 2A, B). After transpancreatic sphincterot-

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Figure 2. (A, B) Endoscopic photographs of transpancreatic sphincterotomy. (C, D) Endoscopic photographs of needle-knife precut sphincterotomy. (E, F) Endoscopic photographs of needle-knife fistulotomy.

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Table 1. Patient’s Age, Gender, and Indications for ERCP With the Type of Primary Precut Technique Type of precut

TPS (n ⫽ 48)

NKS (n ⫽ 30)

NKF (n ⫽ 8)

P value

Mean age ⫾ SD (y) Men Indications Malignant jaundice Stone Bile duct dilation Bile leak

74.9 ⫾ 9.0 30 (63%)

76.0 ⫾ 10.1 24 (80%)

68 ⫾ 5.1 4 (50%)

.26 .17

23 (48%) 22 (46%) 3 (6%) 0

15 (50%) 12 (40%) 2 (7%) 1 (3%)

0 8 (100%) 0 0

.12

TPS, transpancreatic sphincterotomy; NKS, needle-knife sphincterotomy; NKF, needle-knife fistulotomy; SD, standard deviation.

omy, the biliary orifice was cannulated. The biliary orifice was found either at the apex of the incision, immediately left of the pancreatic orifice, or at the starting point of the incision along the left edge. Pancreatic stenting after transpancreatic sphincterotomy was not performed in any of the patients. Needle-knife sphincterotomy was performed in the standard fashion. The incision started from the upper lip of the papillary orifice (at the 11-o’clock position) and proceeded upward over the papillary mound (Figure 2C, D). The extent of the cut was determined by the intraduodenal bile duct, stopping short of the upper margin of the bulge. The needle-knife fistulotomy was performed by making a puncture into the papilla above the orifice and then cutting either upward in a cephalad direction or downward toward the orifice (Figure 2E, F). To assess the efficacy and the safety of the 3 precutting techniques, we assessed the success rate of biliary cannulation and the complication rates among all patients.

Statistical Analysis Parametric data are presented as means and standard deviations. Statistical tests to compare the measured results among the 3 groups were as follows: the ␹2 test, with Yates

correction for continuity where appropriate, was used for comparison of categorical data; the Fisher exact test was used when the numbers were small. For parametric data, one-way analysis of variance was used when 3 means were compared. Differences were considered significant if the P value was less than .05.

Results Baseline characteristics of the 3 groups are summarized in Table 1. No difference among the 3 groups was found regarding age, gender, or indications. The incidence of attempted biliary access with a guidewire before precutting techniques was 27.1% (261 of 964). A total of 86 patients (58 men; mean age, 76 years) or 8.1% of the patients undergoing ERCP during the same period were classified as having difficult to access bile ducts; 48 with small MDP underwent transpancreatic sphincterotomy, 30 with large MDP had needle-knife sphincterotomy, and 8 with swollen MPD had needle-knife fistulotomy (Figure 3). The initial precutting procedure was successful in 96% with small MDP, 90% with large MDP, and 100% with swollen MDP. In 3 patients whose initial attempt with needle-knife sphincterotomy was unsuccessful, subsequent

Figure 3. Success rate according to the type of primary precut technique on the basis of the characteristics of the MDP. TPS, transpancreatic sphincterotomy; NKS, needle-knife precut sphincterotomy; NKF, needle-knife fistulotomy.

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Table 2. Complication According to the Type of Primary Precut Technique Type of precut Bleeding Pancreatitis Perforation

TPS (n ⫽ 48)

NKS (n ⫽ 30)

NKF (n ⫽ 8)

P value

0 1 (2.1%) 0

2 (6.7%) 1 (3.3%) 0

0 0 0

.3 1 1

TPS, transpancreatic sphincterotomy; NKS, needle-knife sphincterotomy; NKF, needle-knife fistulotomy.

transpancreatic sphincterotomy was successful in one. The overall success rate of biliary cannulation after 2 ERCP attempts was 100% (86 of 86). The overall complication rate was 4.7% (4 of 86) including 2 with mild bleeding and 2 with mild pancreatitis (Table 2). Additional biliary therapeutics performed included sphincterotomy (44 patients), nasobiliary tube/biliary stent (41), and common bile duct sweeping (42).

Discussion When a technically challenging biliary cannulation is encountered, the options include precut sphincterotomy, a repeat ERCP at a later date, or a percutaneous approach. Of these, precut sphincterotomy has the advantage of avoiding further procedures with additional risks and costs. The primary indications for precut sphincterotomy are when bile duct obstruction is considered definite or highly probable (eg, stones, strictures), and when there are additional indications for intervention, such as cholangitis or a bile duct leak. Precut sphincterotomy is generally not indicated simply to obtain a diagnostic cholangiogram or when endoscopic intervention is unlikely to be needed.1 Proponents of these several techniques report high success rates, with acceptable complication rates, for selective cannulation of an otherwise inaccessible bile duct.1 Despite these encouraging results, there continues to be reluctance to use precut techniques because of reports of serious complications.10,11 Complication rates for precut techniques have ranged from 6%–34% compared with rates of 7%–14% for conventional sphincterotomy.11–18 The usefulness of precutting techniques such as needle-knife sphincterotomy, needle-knife fistulotomy, or transpancreatic sphincterotomy has been compared previously,7,8 but the selection of the technique has basically depended on the endoscopist’s preference. The most frequently used precutting method is thought to be needle-knife sphincterotomy, although its success rate has been relatively low (60%– 80%), in part because of the difficulty of the technique.1 Our results are consistent with a prior report concerning the usefulness of needle-knife fistulotomy15 in patients with a swollen MDP induced by an impacted bile duct stone. Our success rate for this indication was 100%, and no complications occurred. On the other hand, transpancreatic sphincterotomy might be technically less demanding, and the depth of incision might be easier to control compared with other techniques.5,6,8 However, a concern remains regarding post-ERCP pancreatitis. This study demonstrated the effectiveness and the safety of transpancreatic sphincterotomy when transpancreatic sphincterotomy was used for patients with small MDP without orad protrusion (success rate, 95.8%; complication rate, 2.1%); pancreatic stenting was not performed. Transpancreatic sphincterotomy might be the preferred technique for patients with small MDP in which the

common channel is long, and pancreatic injections with contrast might be made unintentionally. Complications occurred in 3.5%–5.8% of patients (average, 5.5%; 11 of 201) in other studies with transpancreatic sphincterotomy as a precutting technique,6,8 compared with a rate of 2.1% after transpancreatic sphincterotomy in our study. The difference of complication rates in the same technique might be due to the result of the proper selection of precutting techniques on the basis of the characteristics of the MDP. We compared our results with precutting with transpancreatic sphincterotomy, needle-knife sphincterotomy, or needleknife fistulotomy, with the choice of procedure being on the basis of the characteristics of the MDP. Our success rates were higher than previously reported, and the overall complication rate was low (Figure 3 and Table 2). These results suggest that selection of 1 of 3 types of precutting techniques on the basis of the characteristics of the MDP instead of endoscopist preference might result in a high degree of success and a low complication rate for cases with difficult bile duct cannulations. References 1. Freeman ML, Guda NM. ERCP cannulation: a review of reported techniques. Gastrointest Endosc 2005;61:112–125. 2. Huibregtse K, Katon RM, Tytgat GNJ. Precut papillotomy via fineneedle papillotome: a safe and effective technique. Gastrointest Endosc 1986;32:403– 405. 3. Siegel JH, Ben-Zvi JS, Pullano W. The needle knife: a valuable tool in diagnostic and therapeutic ERCP. Gastrointest Endosc 1989; 35:499 –503. 4. Schapira L, Khawaja FI. Endoscopic fistulosphincterotomy: an alternative method of sphincterotomy using a new sphincterotome. Endoscopy 1982;14:58 – 60. 5. Goff JS. Common bile duct pre-cut sphincterotomy: transpancreatic sphincter approach. Gastrointest Endosc 1995;41:502– 506. 6. Akashi R, Kiyozumi T, Jinnouchi K, et al. Pancreatic sphincter precutting to gain selective access to the common bile duct: a series of 172 patients. Endoscopy 2004;36:405– 410. 7. Mavrogiannis C, Liatsos C, Romonos A, et al. Needle-knife fistulotomy versus needle-knife precut papillotomy for the treatment of common bile duct stones. Gastrointest Endosc 1999;50:334 – 339. 8. Catalano MF, Linder JD, Geenen JE. Endoscopic transpancreatic papillary septotomy for inaccessible obstructed bile ducts: comparison with standard pre-cut papillotomy. Gastrointest Endosc 2004;60:557– 619. 9. Cotton PB, Lehman G, Vennes J, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc 1991;37:383–393. 10. Cotton PB. Precut papillotomy: a risky technique for experts only. Gastrointest Endosc 1989;35:578 –579. 11. Boender J, Nix GA, de Ridder MA, et al. Endoscopic papillotomy for common bile duct stones; factors influencing the complication rate. Endoscopy 1994;26:209 –216.

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12. Dowsett JF, Polydorou AA, Varia D. Needle knife papillotomy: how safe and how effective? Gut 1990;31:905–908. 13. Foutch PG. A prospective assessment of results for needle knife papillotomy and standard endoscopic sphincterotomy. Gastrointest Endosc 1995;41:25–32. 14. Goff JS. Long-term experience with the transpancreatic sphincter pre-cut approach. Gastrointest Endosc 1999;50:642– 645. 15. Leung JWC, Banez VP, Chung SCS. Precut (needle knife) papillotomy for impacted common bile duct stone at the ampulla. Am J Gastroenterol 1990;85:991–998. 16. Rabenstein T, Ruppert T, Schneider T, et al. Benefits and risks of needle-knife papillotomy. Gastrointest Endosc 1997;46:207– 211.

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17. Recchia S, Coppola F, Ferrari A, et al. Fistulosphincterotomy in the endoscopic approach to biliary tract diseases. Am J Gastroenterol 1992;87:1607–1609. 18. O’Connor HJ, Bhutta AS, Redmond PL, et al. Suprapapillary fistulosphincterotomy at ERCP: a prospective study. Endoscopy 1997;29:266 –270.

Address requests for reprints to: Akira Horiuchi, MD, Department of Gastroenterology, Showa Inan General Hospital, 3230 Akaho, Komagane 399-4191, Japan. e-mail: [email protected]; fax: ⴙ81-26582-2118.