Risk factors of post-ERCP pancreatitis in high-risk patients despite prevention with prophylactic pancreatic stents.

Objectives: To analyze risk factors of post-ERCP pancreatitis (PEP) in high risk patients in whom prophylactic pancreatic stents (PPSs) were intended to use to prevent endoscopic retrograde cholangiography (ERCP)-related complications.Patients and methods: Three hundred and seventeen high-risk patients for developing PEP were considered for preventive pancreatic stent placement in our endoscopy unit over 5 years. 5 Fr, 3-5 cm long PPSs were used. All data were collected in a predefined database. Development of PEP despite PPS placement was analyzed.Results: PEP occurred in 29 of 288 successfully stented patients (10.07%; 24 mild, four moderate, one severe). PPS was protective against all risks factors except for sphincter of Oddi dysfunction (SOD). PPS related complication rate was 2.78% (n = 8). Unsuccessful stenting occurred in 29 patients (9.15%), PEP developed in 41.38% (n = 12; seven mild, four moderate, one severe). Those patients who had more patient related risk factors were more likely to develop PEP despite preventive measures with PPS. On the contrary, PPS placement was less successful in patients who had more procedure related risk factors.Conclusions: PPS is protective against all risks factors of PEP except for SOD in high-risk patients. More vulnerable patients who have more patient-related risk factors are more likely to develop PEP despite PPS is used, while more complex procedures predispose to unsuccessful PPS placement in patients with more procedure-related risk factors. PPS insertion in high-risk patients is effective and safe preventive method and the procedure related complication rate is reasonably low.

The 3-D muscular structure of the human pancreaticobiliary junction

The musculature of the human pancreaticobiliary junction (PBJ) is implicated in several pathologies and is of significance to clinicians who perform endoscopic retrograde cholangiopancreatography (ERCP). This study sought to describe the musculature of the human PBJ by generating a three-dimensional reconstruction of histologic sections. A single pancreaticoduodenal specimen was removed en bloc from an embalmed cadaver with no pancreaticoduodenal disease. Sections were stained with Masson's trichrome and the staining pattern of muscle fibers was used to generate information regarding their location and orientation. The outline of groups of muscle fibers taken from photomicrographs of alternate thin serial sections were highlighted based upon their orientation (circular or longitudinal) and location (duodenal or papillary). Data point co-ordinates were used to create a 3-D image reconstruction.A total of 91 composite serial cross-sections were reconstructed. Circular and longitudinal muscle fibers formed a completely investing muscle layer around both the bile and pancreatic ducts, and there was a clear distinction between the intrinsic muscles of the PBJ and those of the duodenal wall. Circular fibers were particularly dense distal to the confluence of the ducts. Longitudinal fibers were incompletely distributed around the pancreaticobiliary sphincter and did not extend to the tip of the major duodenal papilla. This model supports the well-established concept of an intrinsic pancreaticobiliary sphincter composed of circular and longitudinal muscle fibers, distinct from the surrounding duodenal muscle. Targeting the distal end of the PBJ during ERCP would only partially disrupt this muscular sphincter mechanism

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Sphincter of Oddi Dysfunction After Gastric Bypass: Surgical or Endoscopic Therapy?

BACKGROUND: Management of Sphincter of Oddi Dysfunction (SOD) requires advanced techniques (endoscopic retrograde cholangiopancreatography via gastrostomy [GERCP]) after Roux-en-Y gastric bypass (RYGB) for obesity. Transduodenal sphincteroplasty (TS) is also performed yet carries the risks of surgery. We hypothesized that TS would have increased morbidity and mortality but provide a more durable remission of symptoms. METHODS: All patients between 2005 and 2016 with RYGB for obesity undergoing endoscopic or surgical management for type I or II SOD were included in the study. Patients with type III SOD, or who underwent RYGB for nonobesity indications, were excluded. RESULTS: Thirty-eight patients were identified. GERCP was initially performed in 17 patients, whereas TS was performed in 21. Thirty-day mortality was 0% in our cohort, and 30-d morbidity was similar between GERCP and TS (29% versus 10%; P = 0.207). Resolution of symptoms after initial therapy was seen in 41% of GERCP (7/17) and 67% of TS (14/21) (P = 0.190), respectively, and overall after 35% (8/23) and 64% (16/24) of procedures performed (P = 0.042). Symptom resolution, as defined by the median ratio of days of total remission by total days of observed follow-up, was shorter after initial and all interventions with GERCP compared with TS (0.67 versus 1.00, P = 0.036 and 0.52 versus 1.00, P = 0.028, respectively). CONCLUSIONS: Endoscopic and surgical treatment of SOD had similar morbidity and mortality. However, treatment success and duration of remission was higher in those treated with surgery.

Cyclic Change of Sphincter of Oddi Motility and Its Relationship with Small Bowel Migrating Motor Complex in Humans.

BACKGROUND: Several animal and human studies have reported that sphincter of Oddi (SO) motility shows cyclical changes during the fasting state. However, to date, the relationship between the SO motility and the migrating motor complex (MMC) of the small bowel (SB) remains unclear in humans. AIMS: We observed SO motility over a long study period and evaluated its relationship with the MMC of the SB in humans using percutaneous long-term manometry. METHODS: Our study included patients with hepatolithiasis who required percutaneous transhepatic catheter placement and subsequently underwent choledochoscopy and stone removal. Long-term percutaneous transhepatic SO manometry was performed after complete stone removal. SO and SB motility were simultaneously recorded. RESULTS: SO motility showed cyclical phasic changes with periodic high-frequency contractions similar to the MMC contractions of the SB. All high-frequency contractions of the SO coincided with phase III contractions of the MMC of the SB. The proportions of phase III contractions of SO and SB were similar, but the proportions of phase I (P = 0.001) and phase II (P = 0.002) contractions were significantly different. The mean basal SO pressure was observed to significantly increase in phase III compared to phase I (P = 0.001) and phase II (P = 0.001) contractions. CONCLUSIONS: SO motility in humans showed cyclical phasic changes closely coordinated with the MMC of the SB in a fasting state; however, the proportion of phases differed between the SO and the SB. The basal pressure significantly increased during physiological high-frequency phase III contractions of the SO.

Periarticular Morphine-Induced Sphincter of Oddi Spasm Causing Severe Pain and Bradycardia in an Awake Patient Under Spinal Anesthesia: An Important Diagnostic Consideration.

Sphincter of Oddi spasm from opioids has been documented, presenting as severe epigastric pain and potentially overlooked in a differential diagnosis. We present a case of sphincter of Oddi spasm from periarticular morphine in a patient under spinal anesthesia, causing severe distress and treated effectively with glucagon. It is important for anesthesiologists using opioids to consider it as a cause of perioperative pain and be familiar with treatment as it may be refractory by conventional use of opioids for pain relief. It is also important to consider the systemic effects of periarticular absorption, as evident by our case.

A Randomized, Clinical Trial Involving Different Surgical Methods Affecting the Sphincter of Oddi in Patients With Choledocholithiasis.

AIM: The purpose of the current study was to compare pressure changes in the sphincter of Oddi (SO) and stone recurrence after surgery in patients with choledocholithiasis who underwent laparoscopic common bile duct exploration during laparoscopic cholecystectomy (LC) or endoscopic sphincterotomy (EST) with LC, which may provide clinical evidence for choledocholithiasis patients to choose the appropriate surgical approach. MATERIALS AND METHODS: Fifty-one patients with choledocholithiasis were randomized to the EST/LC (group A 26 cases) or laparoscopic common bile duct exploration during LC group (group B 25 cases). We performed SO manometry during surgery and 3 months postoperatively on all patients. In addition, the duodenobiliary reflux test was performed during the third month postoperatively. All patients were followed for 24 to 30 months. RESULTS: In group A, the SO basal and contraction pressures were 30.88±16.11 and 77.46±23.62 mm Hg intraoperatively and 10.34±10.27 and 45.65±24.77 mm Hg 3 months postoperatively, respectively. In group B, the SO basal and contraction pressures were 27.80±15.88 and 73.96±23.99 mm Hg intraoperatively and 15.43±7.36 and 59.56±22.61 mm Hg 3 months postoperatively, respectively. During the third month postoperatively, duodenobiliary reflux was demonstrated in 16 of 26 and 7 of 25 patients in groups A and B, respectively (P<0.05). During follow-up, the stone recurrence rates were 6 of 26 in group A and 1 of 25 in group B (P<0.05). CONCLUSIONS: After EST, the SO basal and contraction pressures decreased, and the duodenobiliary reflux and stone recurrence rates increased. Thus, EST should be selected with care.

ENDOSCOPIC METHODS OF DIAGNOSTICS AND TREATMENT OF PAPILLOSTENOSIS.

Differential diagnostics of papillospasm and papillostenosis should be based on the complex of clinical and instrumental researches with the priority to endoscopic technologies. Conservative therapy should be considered as optimal option of treatment for the patients with papillospasm. Preference of endoscopic operations have to be in case of revealed papillostenosis of different degree. Similar differentiated diagnostics and treatment management justified in 90% of cases and led to improvement of patient's conditions and their recovery.

Endoscopic large balloon sphincteroplasty is a useful, safe adjunct for difficult to treat choledocholithiasis.

BACKGROUND: The aim of this study was to assess the safety and efficacy of large balloon sphincteroplasty when used in conjunction with endoscopic biliary sphincterotomy during endoscopic retrograde cholangiopancreatography (ERCP) for therapy of choledocholithiasis. METHODS: A retrospective audit of all ERCP's performed for choledocholithiasis between January 2012 and October 2013 at one institution was performed. Procedures that utilized large balloon sphincteroplasty were compared with those underwent standard endoscopic stone extraction. Outcomes including stone clearance rate for the individual procedure type, post-ERCP complications and need for surgical exploration of the bile duct were documented. RESULTS: A total of 346 procedures on 306 patients that met the inclusion criteria were identified. Fifty-four (15.6%) procedures included large balloon sphincteroplasty and were compared with 292 (84.4%) procedures that used standard balloon extraction techniques. Despite those patients in the large balloon sphincteroplasty group having a higher rate of previous ERCP (33.3% versus 19.5%, P = 0.031) and a larger proportion of patients with stones greater than 10 mm (40.3% versus 11.3%, P < 0.001), the overall initial clearance rate was similar at 83%. Ultimately, only 14 out of 306 (4.6%) of all patients required surgical intervention. There was no significant difference in the rate of post-ERCP pancreatitis between the two groups (5.6% versus 3.8%, P = 0.466). CONCLUSION: Large balloon sphincteroplasty of the sphincter of Oddi is a safe and effective adjunct to endoscopic biliary sphincterotomy in difficult to treat choledocholithiasis. The current study demonstrated large balloon sphincteroplasty did not result in more complications despite a tendency to being used for larger stones.

Moderate and severe postendoscopic retrograde cholangiopancreatography pancreatitis despite prophylactic pancreatic stent placement: the effect of early prophylactic pancreatic stent dislodgement.

BACKGROUND: Placement of prophylactic pancreatic stents (PPS) is a method proven to reduce the rate and severity of postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in high-risk patients; however, PPS do not eliminate the risk completely. Early PPS dislodgement may occur prematurely and contribute to more frequent or severe PEP. OBJECTIVE: To determine the effect of early dislodgement of PPS in patients with moderate or severe PEP. METHODS: A total of 27,176 ERCP procedures from January 1994 to September 2007 for PPS placement in high-risk patients were analyzed. Patient and procedure data were analyzed to assess risk factors for PEP, and to evaluate the severity of pancreatitis, length of hospitalization and subsequent complications. Timing of stent dislodgment was assessed radiographically. RESULTS: PPS were placed in 7661 patients. Of these, 580 patients (7.5%) developed PEP, which was graded as mild in 460 (6.0%), moderate in 87 (1.1%) and severe in 33 (0.4%). Risk factors for developing PEP were not different in patients who developed moderate PEP compared with those with severe PEP. PPS dislodged before 72 h in seven of 59 (11.9%) patients with moderate PEP and five of 27 (18.5%) patients with severe PEP (P=0.505). The mean (± SD) length of hospitalization in patients with moderate PEP with stent dislodgement before and after 72 h were 7.43 ± 1.46 days and 8.37 ± 1.16 days, respectively (P=0.20). The mean length of hospitalization in patients with severe PEP whose stent dislodged before and after 72 h were 21.6 ± 6.11 and 22.23 ± 3.13 days, respectively (P=0.96). CONCLUSION: Early PPS dislodgement was associated with moderate and severe PEP in less than 20% of cases and was not associated with a more severe course. Factors other than ductal obstruction contribute to PEP in high-risk patients undergoing ERCP and PPS placement.

[Periampullar diverticulum--related to bilio-pancreatic disorders]. / Diverticulul duodenal periampular--implicatii in patologia bilio-pancreatica.

UNLABELLED: Periampullar diverticulum (PAD) represent a particular type of duodenal diverticulum, with important pathological effect on the functionality of both the billiary tree and the pancreas. In our retrospective, randomised study, we analised 204 patients who underwent ERCP. We diagnosed 34 PAD (17%). We performed the endoscopic procedure for several pathological conditions of the biliary tract (cholestasis, jaundice, angiocolitis). Most DPA were identified in patients over 60 years (80%), beeing slightly more frequent in males (59%). We found in 25% of patients (over 65 years) with bile duct stones at least one PAD. Over 50% of patients with PAD had bile duct stones. Fibrous, obstructive papillo-odditis was found in 37% of patients with PAD. CONCLUSIONS: 1. PAD are related to bilio-pancreatic disorders, especially to bile duct stones. 2. The most common physio-pathological mechanism is a alteration of the bile flow, due to angulation, compression and/or obstruction of the final part of the bile duct and Wirsung duct, followed by secondary upper stasis. 3. Papillosphincterotomy has technical particularities, because of difficulties in incision orientation (a deformed papilla, with modified anatomical relationships, being situated profound inside the diverticulum cavity). Sphincterotomy depth was limited, which lead to less succesfull extraction of bile stones (89%, compared to the control group 92%). 4. We did not encounter major accidents. Secondary acute pancreatitis after ERCP was similar in both study groups. There was no significant difference in morbidity and mortality rates in both groups.

Correlation of endoscopic ultrasonography (EUS) for differential diagnostics between inflammatory and neoplastic lesions of the papilla of Vater and the peripapillary region with results of histologic investigation.

PURPOSE: There is currently no imaging procedure that allows precise differentiation between inflammatory and malignant lesions of the papilla of Vater (papilla) in a satisfying manner. The aim was to study whether endoscopic ultrasonography (EUS) as an initial diagnostic step 1. may have the potential to distinguish between different tissue characteristics, such as tumor growth or inflammation of the papilla, because of its high resolution capacity and 2. is superior to the accuracy of histologic investigations of mucosal biopsies by means of a prospective collection and retrospective evaluation of the data. PATIENTS AND METHODS: Between 1995 and 2002, a significant pathologic finding in the papilla and the peripapillary region was revealed using EUS in 311 patients (overall, 4,832 EUS investigations); the comparison of this suspicion with the results of histologic investigation was only possible in 183 subjects. In 133/183 patients, a biopsy for histologic investigation was not able to be obtained prior to the use of EUS. Diagnosis was set up using EUS, which tried to differentiate between benign or malignant lesions of the papilla. Histologic investigation of the 133 tumor lesions of the papilla became possible by taking deep transpapillary biopsies following papillotomy, papillectomy or by obtaining specimens from surgical resections. RESULTS: Using EUS, differentiation between inflammatory and neoplastic lesions of the papilla or the peripapillary region was correct in 109 of 133 cases (82%), while suspected EUS-based diagnosis "papillitis stenosans" (inflammatory lesions of the papilla of Vater) in 4 subjects (3%) was corrected to adenoma and carcinoma, respectively (n=2 each) by histologic investigation. In 20 of 133 patients with suspected neoplastic lesions, inflammatory lesion of the papilla of Vater was detected resulting in an overall sensitivity of 92.3% and specificity of 75.3%. CONCLUSIONS: EUS makes it possible to detect small intraampullary tumors and segmental thickening of the wall of the prepapillary biliary duct, which cannot be revealed by conventional imaging. In patients with biliary symptoms, EUS can reliably visualize and characterize a malignant lesion as a first diagnostic tool (detection rate, 82%) and may be considered the basis for subsequent diagnostic steps for verifying diagnosis correctly, e. g., using histologic investigation.

Effect of native somatostatin on Sphincter of Oddi motility in patients with acute recurrent pancreatitis. A pilot study with Ultrasound-Secretin test.

BACKGROUND: The effect of native somatostatin on Sphincter of Oddi motility still remains controversial. Sphincter of Oddi inhibition was demonstrated at manometry in patients in the acute phase of alcoholic pancreatitis. Other investigators showed marked somatostatin-induced impairment of bile flow by hepato-biliary scintigraphy. AIM: Aim of the study was to determine the effects of therapeutical doses of exogenous somatostatin on Sphincter of Oddi motility. PATIENTS AND METHODS: We studied eight patients (two men, six women, age 18-42), in the quiescent phase of idiopathic recurrent pancreatitis. We directly studied Sphincter of Oddi motility by perendoscopic manometry and, indirectly, secretin-stimulated pancreatic juice outflow by Ultrasound-Secretin test. The two tests were repeated before and after somatostatin infusion. RESULTS: Manometry was performed in two patients. After 250 microg somatostatin bolus the sphincter showed an increase of motor activity. At Ultrasound-Secretin test mean diameters were significantly larger at 40-60 min evaluation intervals during 250 microg/h somatostatin infusion as compared to saline infusion, showing a delayed pancreatic duct emptying. CONCLUSIONS: Acute administration of somatostatin seems to induce an excitatory effect on Sphincter of Oddi motility, with impaired pancreatic outflow in patients in the quiescent phase of recurrent pancreatitis.

[Immediate and long-term effects of endoscopic papillosphincterotomy in patients with cholelithiasis].

The subjects of the study were 164 patients, divided into two groups. Group I included 76 patients at the physicochemical stage of cholelithiasis, and 38 patients after cholecystectomy, who underwent endoscopic papillosphincterotomy (EPST). Group II (control) included 30 patients at the physicochemical stage of cholelithiasis, and 20 patients after cholecystectomy, who did not undergo EPST. Endoscopic retrograde pancreatocholangiography revealed type II Oddi's sphincter dysfunction in all the patients. Evaluation of the chemical composition of bile in Group I, performed 6, 12, 18, and 24 months after EPST, revealed its graduate stabilization. In Group II the dynamics of bile composition was negative--in 8 patients bile became more lithogenic. Long-term observations showed that 6 years after EPST bile was lithogenic only in 4 Group I patients, while at the same moment in 25 Group I patients bile lithogenicity did not disappear, but even worsened. Biliferous tract ultrasonography, performed long after EPST, found biliary sludge in 4 Group I patients. 6-year observation of Group Il patients, including ultrasonography, demonstrated that during the 4th year of observation biliary sludge occurred in as many as 28 patients, in 15 of whom small concrements on the bottom of the gall bladder were found during the 5-6th year of observation, and in 3 of whom a solitary concrement of 4 to 5 mm in diameter was found in the choledoch. The results demonstrate that it is appropriate to perform EPST as early as at the physicochemical stage of cholelithiasis, because this procedure results in stabilization of biliary colloid balance and thus prevents biliary sludge and forming of gall bladder concrements. At the same time, 36% of patients with cholelithiasis at various stages who did not undergo EPST, formed gall bladder concrements. EPST is also appropriate in some patients after cholecystectomy, in order to prevent repeating gall bladder concrement formation.

[Biliary tract in patients with chronic viral hepatitides].

AIM: To characterize motor-kinetic and inflammatory changes in extrahepatic biliary tracts and gallbladder in patients with chronic viral hepatitis (CVH). To ascertain whether there is a pathogenetic correlation between affection of the biliary system and viral infection. MATERIAL AND METHODS: The condition of the biliary tract was examined in 183 patients with CVH using fractionated duodenal tubing with biochemical tests and bacteriological investigation of bile, dynamic ultrasonic investigation. RESULTS: 69.9% patients were diagnosed to have dysfunction of the Oddi's sphyncter caused by its hypertonicity, 4.4% patients had hypotonic sphyncter. Hyper- and hypotonicity of the gallbladder were observed in 45.8 and 20.8% patients, respectively. Biliary dysfunction was associated with the process activity but not with a nosological form of the disease. Chronic acalculous cholecystitis was verified in 21.2% patients. CONCLUSION: Chronic HBV and HCV infections are accompanied with biliary dysfunctions associated with activity of inflammation in the liver. Oddi's sphincter dysfunction in CVH is a risk factor of gallbladder inflammation.

Characterization of basal hepatic bile flow and the effects of intravenous cholecystokinin on the liver, sphincter, and gallbladder in patients with sphincter of Oddi spasm.

The major objectives of this project were to establish the pattern of basal hepatic bile flow and the effects of intravenous administration of cholecystokinin on the liver, sphincter of Oddi, and gallbladder, and to identify reliable parameters for the diagnosis of sphincter of Oddi spasm (SOS). Eight women with clinically suspected sphincter of Oddi spasm (SOS group), ten control subjects (control group), and ten patients who had recently received an opioid (opioid group) were selected for quantitative cholescintigraphy with cholecystokinin. Each patient was studied with 111-185 MBq (3-5 mCi) technetium-99m mebrofenin after 6-8 h of fasting. Hepatic phase images were obtained for 60 min, followed by gallbladder phase images for 30 min. During the gallbladder phase, 10 ng/kg octapeptide of cholecystokinin (CCK-8) was infused over 3 min through an infusion pump. Hepatic extraction fraction, excretion half-time, basal hepatic bile flow into the gallbladder, gallbladder ejection fraction, and post-CCK-8 paradoxical filling (>30% of basal counts) were identified. Seven of the patients with SOS were treated with antispasmodics (calcium channel blockers), and one underwent endoscopic sphincterotomy. Mean (+/-SD) hepatic bile entry into the gallbladder (versus GI tract) was widely variable: it was lower in SOS patients (32%+/-31%) than in controls (61%+/-36%) and the opioid group (61%+/-25%), but the difference was not statistically significant. Hepatic extraction fraction, excretion half-time, and pattern of bile flow through both intrahepatic and extrahepatic ducts were normal in all three groups. Gallbladder mean ejection fraction was 9%+/-4% in the opioid group; this was significantly lower (P<0.0001) than the values in the control group (54%+/-18%) and the SOS group (48%+/-29%). Almost all of the bile emptied from the gallbladder refluxed into intrahepatic ducts; it reentered the gallbladder after cessation of CCK-8 infusion (paradoxical gallbladder filling) in all eight patients with SOS, but in none of the patients in the other two groups. Mean paradoxical filling was 204% (+/-193%) in the SOS group and less than 5% (P<0.05) in both the control and the opioid group. After treatment, six of the SOS patients had complete pain relief and one, partial pain relief. The basal tonus of the sphincter is variable in patients with SOS, and allows relatively more of the hepatic bile to enter the GI tract than the gallbladder. Due to simultaneous contraction of the sphincter and gallbladder in response to CCK-8, most of the bile emptied from the gallbladder refluxes into intrahepatic ducts, and reenters the gallbladder immediately after cessation of hormone infusion. The characteristic features of gallbladder filling, emptying, and paradoxical refilling with cholecystokinin provide objective parameters for noninvasive diagnosis of SOS by quantitative cholescintigraphy.

Preserved function of the Oddi sphincter after endoscopic papillary balloon dilation.

BACKGROUND/AIMS: Endoscopic papillary balloon dilation (EPBD) is a safe and effective procedure for the treatment of bile duct stones that appears to be less hazardous to the sphincter of Oddi than endoscopic sphincterotomy. However, little is known about the function of Oddi muscle after EPBD. The aim of the present study is to evaluate Oddi muscle function using quantitative cholescintigraphy. METHODOLOGY: This study was conducted using 12 patients treated for bile duct stones by EPBD, and 8 patients treated by endoscopic sphincterotomy, followed by laparoscopic cholecystectomy thereafter. For the controls, 10 asymptomatic cholecystectomized patients were used. From 1-3 years after the interventional procedures, patients received a quantitative cholescintigraphy examination using 185 MBq of technetium-99m-N-pyridoxyl-5-methyl-tryptophan. The hepatic hilum-duodenum transit time on quantitative cholescintigraphy was measured as the time interval between the initial appearance of isotope activity at the hepatic hilum and that at the duodenum. RESULTS: Mean hilum-duodenum transit time in patients after EPBD (6.3 min, 95%CI 4.5-8.0) was not different from that in control patients (6.5 min, 95%CI 4.3-8.7), whereas mean hilum-duodenum transit time in endoscopic sphincterotomy patients (3.2 min, 95%CI 2.4-4.0) was markedly shorter than both the control and EPBD groups (p = 0.0053). CONCLUSIONS: The function of the sphincter of Oddi may be preserved after endoscopic papillary balloon dilation.