经胰管弓式隔膜乳头预切开术和针式乳头预切开术在困难胆管插管中的应用研究

目的评价经胰管弓式隔膜乳头预切开术处理ERCP困难胆管插管的应用价值。方法回顾2006年1月至2008年7月109例ERCP胆总管插管困难患者进行经胰管弓式隔膜乳头预切开术（下称经胰管组,56例）和常规针式乳头预切开术（下称常规针刀组,53例）的临床资料,比较两种方法插管成功率及并发症发生率。结果109例患者中的97例在乳头预切开术后可成功插入胆管,经胰管组成功率96．4％（54／56）,常规针刀组成功率81．1％（43／53）,两者差异具统计学意义（P〈0．05）。109例中11例出现并发症,包括急性胰腺炎5例、出血4例、胆道感染2例。其中,经胰管组急性胰腺炎2例,常规针刀组急性胰腺炎3例,出血4例,胆道感染2例。两组比较,经胰管组总的并发症发生率低于常规针刀组（3．6％比17．0％,P〈0．05）,术后胰腺炎、出血、感染发生率也分别低于后者,但均无统计学意义。结论内镜经胰管弓式隔膜乳头预切开术超选胆总管成功率高于针式乳头预切开术,而且并发症较低,是处理选择性胆总管插管较困难患者的安全和有效的办法。     

Endoscopic transpancreatic septotomy as a precutting technique for difficult bile duct cannulation

AIM: To evaluate the technique of transpancreatic septotomy(TS) for cannulating inaccessible common bile ducts in endoscopic retrograde cholangiopancreatography(ERCP).METHODS: Between May 2012 and April 2013, 1074 patients were referred to our department for ERCP. We excluded 15 patients with previous Billroth Ⅱ gastrectomy, Roux-en-Y anastomosis, duodenal stenosis, or duodenal papilla tumor. Among 1059 patients who underwent ERCP, there were 163 patients with difficult bile duct cannulation. Pancreatic guidewire or pancreatic duct plastic stent assistance allowed for successful ERCP completion in 94 patients. We retrospectively analyzed clinical data from 69 failed patients(36 transpancreatic septotomies and 33 needle-knife sphincterotomies). RESULTS: Of the 69 patients who underwent precut papillotomy, common bile duct cannulation was successfully achieved in 67. The success rates in the TS and needle knife sphincterotomy(NKS) groups were 97.2%(35/36) and 96.9%(32/33), respectively, which were not significantly different(P 0.05). Complications occurred in 11 cases, including acute pancreatitis(n = 6), bleeding(n = 2), and cholangitis(n = 3). The total frequency of complications in the TS group was lower than that in the NKS group(8.3% vs 24.2%, P 0.05).CONCLUSION: Pancreatic guidewire or pancreatic duct plastic stent assistance improves the success rate of selective bile duct cannulation in ERCP. TS and NKS markedly improve the success rate of selective bile duct cannulation in ERCP. TS precut is safer as compared with NKS.     

Long-term experience with the transpancreatic sphincter pre-cut approach to biliary sphincterotomy.

BACKGROUND: The transpancreatic duct pre-cut to gain access to the bile duct for diagnostic and therapeutic maneuvers has been described as useful, but questions of efficacy and safety remain to be resolved. METHODS: To further evaluate this technique, we performed a review on 200 consecutive endoscopic sphincterotomies. Standard direct biliary sphincterotomy was performed in 143 patients and transpancreatic duct pre-cut in 51 patients. RESULTS: The overall complication rate for the standard sphincterotomy was 2.1%; that for the transpancreatic approach was 1.96%. There were no cases of post-ERCP pancreatitis after transpancreatic duct pre-cut sphincterotomy. The length of hospital stay was 1 day or less for 192 patients, 2 days for 5 patients, 4 days for 1 patient and 7 days for 2 patients. In 2 patients there was failure to enter the bile duct despite the pre-cut. In one, the procedure was successful at a second attempt 48 hours later. CONCLUSIONS: Transpancreatic duct pre-cut is a safe and effective method for gaining quick access to the bile duct in patients in whom cannulation is difficult.     

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.

3种辅助插管技术在ERCP胆管插管困难病例中的临床应用

目的对比双导丝插管技术、针状刀乳头预切开术与经胰管乳头预切开术3种辅助插管技术在ERCP胆管插管困难病例中的成功率和并发症发生率,探讨安全有效的辅助插管技术。方法将104例经内镜逆行胰胆管造影(ERCP)选择性胆管插管困难患者随机分成3组分别行3种不同辅助插管技术,即双导丝插管术组(A组)35例,针状刀乳头预切开组(B组)35例,经胰管乳头预切开组(C组)34例。对比3组患者辅助胆管插管的成功率、获得成功插管的时间与并发症的发生率。结果 A组辅助插管成功率为51.43%(18/35),B组为91.43%(32/35),C组为70.59%(24/34),3组成功率差异均有统计学意义(P<0.05)。3组成功插管时间分别为(7.83±1.08)min,(8.20±0.91)min和(7.91±1.20)min,3组成功插管时间无显著性差异(P>0.05)。3组患者术后胰腺炎发生率分别为:2.86%(1/35),22.86%(8/35)与8.82%(3/34),3组间术后胰腺炎发生率差异有统计学意义(P<0.05)。3组患者均无严重感染、大出血、穿孔等并发症发生。结论 3种辅助插管技术均可提高胆管插管成功率,其中针状刀乳头预切开术与经胰管乳头预切开术有更高的成功率,但术后胰腺炎等并发症发生率亦较高;双导丝插管术成功率较低,但安全性较高。     

Application of needle-knife in difficult biliary cannulation for endoscopic retrograde cholangiopancreatography

Introduction Endoscopic retrograde cholangiopancreatography (ERCP) is widely used in the diagnosis and treatment of biliary disorders. Getting directly into the common bile duct (CBD) is the most important step for successful therapeutic endoscopy. The cannulation success rate depends on patient selection, the utilization of specialized catheters, and the skill and experience of the endoscopist. This improved significantly when the clever-cut knife with guidewire was introduced. However, i…     

Papillary roof incision using the Erlangen-type pre-cut papillotome to achieve selective bile duct cannulation

Background: Prior studies evaluating pre-cutting the major papilla to access the bile duct when standard cannulation fails have usually used the needle-knife papillotome. We conducted a prospective study to evaluate the efficacy and safety of an Erlangen-type pre-cut papillotome for pre-cutting. Patients and Methods: Three hundred twenty-seven patients (114 men, mean age 67 years) who underwent first-time sphincterotomy at our institution were included. Pre-cutting was performed if free and wire-guided cannulation of the bile duct failed according to an algorithm. Results: Pre-cutting was performed in 123 patients (38%) and selective cannulation was successful in all. Post-ERCP serum pancreatic enzyme levels were more frequently elevated in the pre-cut group (50%) than the non-pre-cut group (27%, p < 0.001); however, there was no difference in the incidence of post-ERCP pancreatitis (pre-cut = 2.7%, 95% CI: 0.66% to 7.6%; non-pre-cut = 1.6%, 95% CI: 0.3% to 4.7%). The incidence of bleeding was similar (pre-cut, 2.4%, non-pre-cut, 3.9%; p > 0.05). Conclusion: Pre-cutting the major papilla for biliary access using the Erlangen-type pre-cut papillotome is an effective and reasonably safe procedure when performed by endoscopists with extensive experience in pancreatobiliary endoscopy. (Gastrointest Endosc 1996;44:689-95.)     

Early institution of pre-cutting for difficult biliary cannulation: a prospective study comparing conventional vs. a modified technique

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

Accidental cannulation of the hepatic artery following needle-knife sphincterotomy

The use of needle-knife sphincterotomy has become an established technique for precut sphincterotomy to achieve am otherwise inaccessible bile duct. The present case report describes an accidental cannulation of the proper hepatic artery following needle-knife sphincterotomy. The endoscopic retrograde cholangiopancreaticography (ERCP) was performed for diagnosis and treatment of a pancreatitis presumably caused by cholelithiasis. After guide-wire placement and angiography of the artery through the papilla, there were no further complications. The distance between the catheter and the hepatic hilus was seen under X-ray control.     

Precut papillotomy using needle knife fashioned from discarded standard papillotomes.

AIM: To evaluate the results of precut papillotomy using needle-knife papillotomes fashioned from discarded standard sphincterotomes. METHODS: Case records of 50 patients undergoing precut papillotomy for access to either common bile duct or pancreatic duct during endoscopic retrograde cholangiopancreatography were reviewed. Precut was performed using needle-knife papillotomes fashioned from standard pull-type sphicterotomes that were discarded because of broken cutting wires. A diagnostic procedure was planned in all 50 patients (bile duct = 39, pancreatic duct = 9, both ducts = 2) and therapeutic procedure in 36 patients (bile duct = 31, pancreatic duct = 5). RESULTS: Of the 47 patients who needed precut prior to diagnostic ERCP, 44 (93.6%) underwent successful cannulation of the duct of choice. Therapeutic procedures were planned in 36 patients; these were successful in 24 (67%; bile duct = 22, pancreatic duct = 2). The complications included cholangitis in 8 patients (16%) and pancreatitis in 2 (4%). None had bleeding or perforation. CONCLUSIONS: Precut needle-knife papillotomes fashioned from discarded standard sphincterotomes can be used effectively and can help in cost containment in endoscopic retrograde cholangiopancreatography.     

Different Strategies for Transpancreatic Septotomy and Needle Knife Infundibulotomy Due to the Presence of Unintended Pancreatic Cannulation in Difficult Biliary Cannulation

Background/Aims

Several precut techniques have been used to gain biliary access for difficult cases. The aim of this study was to evaluate the success and complication rates of two precut techniques, transpancreatic septotomy (TPS) and needle knife infundibulotomy (NKI), in difficult biliary cannulation due to the presence of unintended pancreatic cannulation.

Methods

Eighty-six patients who failed standard biliary cannulation were included. TPS was performed when we failed to achieve biliary access despite 5 minutes of attempted cannulation or when more than three attempted unintended pancreatic cannulations occurred. If deep cannulation was not achieved within 5 minutes for any duct, NKI was performed. If this failed, we crossed over to the other technique in the second attempt.

Results

The initial total success rate of biliary cannulation was 88.4% (86.6% for the TPS group and 94.7% for the NKI group, p=0.447). After crossover of the techniques, the final success rate was 95.3%. The complication rate was 20.9% in patients with TPS and 15.8% in patients with NKI (p=0.753).

Conclusions

The use of different strategies based on the presence of unintended pancreatic cannulation may help increase the success rate for difficult biliary cannulation without increasing complication rates.     

针状刀乳头开窗术在ERCP困难插管中的应用

目的 探讨采用针状刀实施十二指肠乳头开窗术,在ERCP困难胆管插管中的应用价值及其安全性.方法 回顾性分析近年来接受ERCP治疗的患者中,当常规插管方法和（或）其他预切开技术无法进入胆管时,采用针状刀在主乳头背部选点进行电灼造口,完成胆管深插管及后续治疗.观察本方法的成功率和术后并发症,并对相关影响因素进行分析.结果 共有108例患者接受开窗术,其中97例（91.2%）成功插至胆管;11例胆管恶性梗阻患者虽经开窗仍无法进入胆管,其中远端恶性梗阻失败率（25.8%,8/31）,明显高于近端梗阻（5.3%,3/57）,（P=0.014,χ^2=5.983）.ERCP术后发生胰腺炎5例（4.6%）,其中插管失败组（18.2%,2/11）明显高于成功组（3.1%,3/97）（P=0.006,χ^2=7.418）;另有肠道穿孔1例、胆管炎4例,均经保守治疗控制.结论 在困难胆管插管的ERCP病例中,应用针状刀行乳头开窗术可以有效提高ERCP诊治的成功率,对于有经验的操作者该方法是较为安全的;但远端胆管恶性梗阻行乳头开窗术的成功率较低.     

胰管导丝占据法在困难内镜逆行胰胆管造影中的应用价值

目的评价胰管导丝占据法在内镜逆行胰胆管造影（ERCP）中胆管选择性插管困难时的应用价值。方法2008年6月至2012年6月间共3505例患者符合入选条件。开始均尝试对患者用导丝辅助的括约肌切开刀行选择性胆管插管（标准法）,若导丝反复进入胰管5次仍未插管成功则导丝留置于胰管,退出切开刀另用一根导丝尝试插管（占据法）,尝试失败则行经胰预切开或针状刀乳头开窗术（占据法失败行预切开）,若尝试插管达5次胰管亦未能进入则行针状刀乳头开窗术（胆胰管插管失败行预切开）。比较各组间胆管插管成功率及并发症的发生率。结果标准法插管成功率（93．4％）明显高于占据法（54．8％,P〈0．001）、占据法失败行预切开（81．3％,P〈0．001）及胆胰管插管失败行预切开（84．6％,P=0．011）;占据法失败行预切开及胆胰管插管失败行预切开插管成功率均明显高于占据法（P值均〈0．001）;各组间术后胰腺炎发生率差异无统计学意义。标准法插管成功后行括约肌切开有2例出血,行预切开插管患者中有5例出血、1例穿孔,无死亡病例。结论胰管导丝占据法胆管插管成功率虽不高,但当标准插管法困难时应首先尝试,以尽量避免预切开的风．呤．     

Endoscopic salvage therapy after failed biliary cannulation using advanced techniques: A concise review

Therapeutic endoscopic retrograde cholangiopancreatography (ERCP) begins with successful biliary cannulation. However, it is not always be successful. The failure of the initial ERCP is attributed to two main aspects: the papilla/biliary orifice is endoscopically accessible, or it is inaccessible. When the papilla/biliary orifice is accessible, bile duct cannulation failure can occur even with advanced cannulation techniques, including double guidewire techniques, transpancreatic sphincterotomy, needle-knife precut papillotomy, or fistulotomy. There is currently no consensus on the next steps of treatment in this setting. Therefore, this review aims to propose and discuss potential endoscopic options for patients who have failed ERCP due to difficult bile duct cannulation. These options include interval ERCP, percutaneous-transhepatic-endoscopic rendezvous procedures (PTE-RV), and endoscopic ultrasound-assisted rendezvous procedures (EUS-RV). The overall success rate for interval ERCP was 76.3% (68%-79% between studies), and the overall adverse event rate was 7.5% (0-15.9% between studies). The overall success rate for PTE-RV was 88.7% (80.4%-100% between studies), and the overall adverse event rate was 13.2% (4.9%-19.2% between studies). For EUS-RV, the overall success rate was 82%-86.1%, and the overall adverse event rate was 13%-15.6%. Because interval ERCP has an acceptably high success rate and lower adverse event rate and does not require additional expertise, facilities, or other specialists, it can be considered the first choice for salvage therapy. EUS-RV can also be considered if local experts are available. For patients in urgent need of biliary drainage, PTE-RV should be considered.     

Pre-cut papillotomy with a new papillotome

BACKGROUND: 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. METHODS: 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. OBSERVATIONS: 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. CONCLUSIONS: 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.     

经胰管预切开联合胰管支架置入法在困难胆管插管中的应用

目的 探讨经胰管预切开联合胰管支架置入法在经内镜逆行性胰胆管造影术(endoscopic retrograde cholangiopancreatography,ERCP)乳头困难插管中的应用价值。方法 纳入2017年1月—2019年12月在海军医科大学第三附属医院行ERCP治疗的169例乳头插管困难病例,其中137例采用双导丝法,32例患者采用经胰管预切开联合胰管支架置入法,观察两组的插管成功率、插管时间以及术后并发症等。结果 双导丝组和经胰管预切开联合胰管支架置入组的插管成功率分别为98.54％(135／137)和100.00％(32／32)(P>0.05);两组的插管时间分别为(15.69±9.07)min 和(17.06±5.79)min(P>0.05);术后并发症发生率分别是25.55％(35／137)和 9.38％(3／32)(P<0.05),其中胰腺炎发生率分别是5.8％(8／137)和0。结论 ERCP乳头插管困难时采用经胰预切开联合胰管支架置入法,具有与双导丝技术相似的成功率,同时更加安全,值得临床推广应用。     

Double guidewire technique vs transpancreatic precut sphincterotomy in difficult biliary cannulation

AIM:To compare the outcomes between doubleguidewire technique(DGT) and transpancreatic precut sphincterotomy(TPS) in patients with difficult biliary cannulation.METHODS:This was a prospective,randomized study conducted in single tertiary referral hospital in Korea.Between January 2005 and September 2010.A total of 71 patients,who bile duct cannulation was not possible and selective pancreatic duct cannulation was achieved,were randomized into DGT(n = 34) and TPS(n = 37) groups.DGT or TPS was done for selective biliary cannulation.We measured the technical success rates of biliary cannulation,median cannulation time,and procedure related complications.RESULTS:The distribution of patients after randomization was balanced,and both groups were comparable in baseline characteristics,except the higher percentage of endoscopic nasobiliary drainage in the DGT group(55.9% vs 13.5%,P < 0.001).Successful cannulation rate and mean cannulation times in DGT and TPS groups were 91.2% vs 91.9% and 14.1 ± 13.2 min vs 15.4 ± 17.9 min,P = 0.732,respectively.There was no significant difference between the two groups.The overall incidence of post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis was 38.2% vs 10.8%,P < 0.011 in the DGT group and the TPS group;post-procedure pancreatitis was significantly higher in the DGT group.But the overall incidence of post-ERCP hyperamylasemia was no significant difference between the two groups;DGT group vs TPS group:14.7% vs 16.2%,P < 1.0.CONCLUSION:When free bile duct cannulation was difficult and selective pancreatic duct cannulation was achieved,DGT and TPS facilitated biliary cannulation and showed similar success rates.However,post-procedure pancreatitis was significantly higher in the DGT group.     

Double guide-wire technique versus transpancreatic biliary sphincterotomy for difficult biliary cannulation: Real life experience from a referral center

BackgroundDuring ERCP for biliary indication, when a difficult bile duct (BD) cannulation occurs, with unintended access to the main pancreatic duct (PD), both double guidewire technique (DGW) and transpancreatic biliary sphincterotomy (TPBS) can be performed. We aimed to compare the technical success and adverse events (AEs) rate of these techniques.MethodsA retrospective analysis of patients with naïve papillae referred to the Pancreas Institute of Verona from January 2016 and July 2021 to undergo ERCP for biliary indications was performed.ResultsOverall, 202 patients (53.5% males, mean age 67.2 years) were evaluated (96 DGW, 106 TPBS). Malignant biliary stricture was the most common ERCP indication (78.2%). The rate of success in deep biliary cannulation was significantly higher in the DGW group (94.8%) compared to TPBS (79.2%) at the first attempt (p = 0.001). This result was also confirmed in the subgroup of patients with malignant distal stricture (72/77, 93.5% vs 63/80, 78.8%, p = 0.01). No significant difference in AEs rate, particularly in PEP incidence was found between the two groups.ConclusionsDGW demonstrated a higher success rate and similar safety profile compared with TPBS in difficult biliary cannulation. Based on this retrospective study, DGW should be preferred over TPBS in case of unintended PD cannulation. Further prospective studies are needed to confirm our results.     

Guidewire cannulation reduces risk of post-ERCP pancreatitis and facilitates bile duct cannulation

OBJECTIVE: To evaluate if using a soft-tipped guidewire to cannulate the common bile duct may ameliorate development of post-ERCP pancreatitis and facilitate cannulation of the CBD. DESIGN AND SETTING: A single-center, blinded, randomized trial of conventional cannulation technique using sphinctertome and contrast injection versus guidewire cannulation technique. METHODS: We prospectively randomized 300 patients to conventional cannulation (group I) or guidewire cannulation (group II) technique. OUTCOME MEASURES: Primary outcome measure was incidence of acute pancreatitis and secondary outcome measures were ease of cannulation of common bile duct (assessed by attempts required for common bile duct cannulation & rates of precut sphincterotomy) and overall complication rates. RESULTS: Guidewire cannulation was associated with significantly lower likelihood of post-ERCP pancreatitis (adjusted OR 0.43, 95% CI 0.21-0.89, P= 0.02). Twenty-five patients (16.6%) in group I and thirteen patients (8.6%) in group II developed acute pancreatitis, P= 0.037. All instances of pancreatitis were mild. There were more women in group II; 41 in group I and 59 in group II, P= 0.028. Otherwise the two groups were comparable for age, age under 35 yr, indication for ERCP, diagnosis, and number of patients with SOD. The number of patients requiring 0-3, 4-6, and 7-10 attempts for successful cannulation of the common bile duct were 87, 48, and 15 in group I and 117, 24, and 9 in group II, respectively, P= 0.001. A total of 33 patients in group I and 13 patients in group II required precut sphincterotomy, P= 0.007. Rates of accidental pancreatic duct cannulation were 21 in group I and 27 in group II, P= 0.34. Rates of overall complication were not significantly different in the two groups. CONCLUSIONS: Guidewire technique for bile duct cannulation lowers likelihood of post-ERCP pancreatitis by facilitating cannulation and reducing need for precut sphincterotomy.     

0.025-inch vs 0.035-inch guide wires for wire-guided cannulation during endoscopic retrograde cholangiopancreatography: A randomized study

AIM:To compare the clinical outcomes between 0.025-inch and 0.035-inch guide wires(GWs) when used in wire-guided cannulation(WGC).METHODS:A single center,randomized study was conducted between April 2011 and March 2013. This study was approved by the Medical Ethics Committee at our hospital. Informed,written consent was obtained from each patient prior to study enrollment. Three hundred and twenty-two patients with a na?ve papilla of Vater who underwent endoscopic retrograde cholangiopancreatography(ERCP) for the purpose of selective bile duct cannulation with WGC were enrolled in this study. Fifty-three patients were excluded based on the exclusion criteria,and 269 patients were randomly allocated to two groups by a computer and analyzed:the 0.025-inch GW group(n = 109) and the 0.035-inch GW group(n = 160). The primary endpoint was the success rate of selective bile duct cannulation with WGC. Secondary endpoints were the success rates of the pancreatic GW technique and precutting,selective bile duct cannulation time,ERCP procedure time,the rate of pancreatic duct stent placement,the final success rate of selective bile duct cannulation,andthe incidence of post-ERCP pancreatitis(PEP).RESULTS:The primary success rates of selective bile duct cannulation with WGC were 80.7%(88/109) and 86.3%(138/160) for the 0.025-inch and the 0.035-inch groups,respectively(P = 0.226). There were no statistically significant differences in the success rates of selective bile duct cannulation using the pancreatic duct GW technique(46.7% vs 52.4% for the 0.025-inch and 0.035-inch groups,respectively; P = 0.884) or in the success rates of selective bile duct cannulation using precutting(66.7% vs 63.6% for the 0.025-inch and 0.035-inch groups,respectively; P = 0.893). The final success rates for selective bile duct cannulation using these procedures were 92.7%(101/109) and 97.5%(156/160) for the 0.025-inch and 0.035-inch groups,respectively(P = 0.113). There were no significant differences in selective bile duct cannulation time(median ± interquartile range:3.7 ± 13.9 min vs 4.0 ± 11.2 min for the 0.025-inch and 0.035-inch groups,respectively; P = 0.851),ERCP procedure time(median ± interquartile range:32 ± 29 min vs 30 ± 25 min for the 0.025-inch and 0.035-inch groups,respectively; P = 0.184) or in the rate of pancreatic duct stent placement(14.7% vs 15.6% for the 0.025-inch and 0.035-inch groups,respectively; P = 0.832). The incidence of PEP was 2.8%(3/109) and 2.5%(4/160) for the 0.025-inch and 0.035-inch groups,respectively(P = 0.793).CONCLUSION:The thickness of the GW for WGC does not appear to affect either the success rate of selective bile duct cannulation or the incidence of PEP.