- Email: [email protected]
Frequency of abnormal biliary and pancreatic basal sphincter pressure at sphincter of Oddi manometry (SOM) in 463 patients
ERCP-BILIARY ~'361
363
FREQUENCY OF ABNORMAL BILIARY AND PANCREATIC BASAL SPHINCTER PRESSURE AT SPHINCTER OF ODDI MANOMETRY (SOM) IN 463 PATIENTS. ~ , Stuart Sherman, Lois Bucksot, Dee Earle, Michael Rusche, Klaus Gottlieb, Glen Lehman. Indiana University Medical Center, Indianapolis, IN. 9 Sphincter of Oddi dysfunction can be fully classified and detected only if both the pancreatic and biliary portions of the sphincter are simultaneously studied. METHODS: From 1993-5, SOM was successfully performed on both the pancreatic and bile ducts in 463 patients who had idiopathic pancreatitis or pain suggestive o f a pancreatobiliary origin. One to three station pull throughs were done in each duct using the WilsonCook aspirating triple lumen catheter perfused at .25 mi/min/lumen. The basal sphincter pressure was determined for each lead and averaged for all pull throughs for that duct. A basal sphincter pressure > 40 mmHg was considered abnormal. Phasic waves were not tallied. RESULTS:
IMPROVEMENT IN POST-ERCP PANCREATITIS OCCURRED IN A COMMUNITY PRACTICE FOLLOWING A TECHNIQUE CHANGE Mark S. Feldman, Memorial and St. Elizabeth's Hospitals, Belleville, IIi Introduction: The frequency of post-ERCP pancreatitis in my private practice was examined before and after a change in technique occurred. In mid July 1994, I approached ERCP's differently in three ways. This included: (a) the liberal use of a precut papillotomy (use after 15 mins. of failed cannulation by a standard catheter), (b) I abandoned blind probing with guidewires, and (c) technically difficult cases were kept NPO until the following morning. I did a chart review for one year before and one year after the technical changes took place. Method: All patients in my practice with a CPT code for ERCP between 7/15/93 and 7/i5/95 were entered into a database. Cases before 7/15/94 (old technique) were in group 1 (no sphincterotomy) or group 2 (sphincterotomy). Cases after that date (new technique) were in group 3 (no sphincterotomy) or group 4 (sphincterotomy). All outpatient and inpatient charts were reviewed by hand by myself. 'Mild' pancreatitis = abdominal pain and elevated amylase ever 48 hrs, moderate = pain over 4 days, and severe = pain over 7 days. Patients were labeled as having nonpanereatitis pain for symptoms lasting over 24 hrs.
PTS. WITHABNORMALBASAL SPHINCTERPRESSURE (%) Prior Sphincter Therapy Yes (n=183)
PancreasAlone
BiliaryAlone
Both
Total
72 (39%)
2 (1%)
16 (9%)
90 (49%)
.No (n=280)
52 (19%) 25 (9%) 76 (27%) 153 (55%) SUMMARY: 1) Basal sphincter pressure abnormalities are present at SOM in approximately one half of thoroughly studied patients in our ERCP unit. 2) Among the 153 previously untreated patients with an abnormal.basal pressure, 76 (50%) had elevation of both the biliary and pancreatic sphincter segments. 3) Concordance between biliary and pancreatic (both normal or abnormal) basal sphincter pressure for previously untreated patients was 73%. 4) After biliary sphincterotomy, symptomatic patients have a high frequency of pancreatic basal sphincter abnormalities. CONCLUSION: Both pancreatic and biliary portions of the sphincter of Oddi must be evaluated to fully define sphincter dysfunction.
and under" 48 h r s . Results:_ Patient groups were identical for age, sex, and diagnosis. Group 1 (n = 116) pancreatitis = 8 pts. or 6.9% (4 mild, 3 moderate, 1 severe). Total patients with abdominal pain = 11 pts. or 9.4%. Group 2 (n = 50) pancreatitis = 2 pts. or 4% (both severe). Total pts. with pain = 8 pts. or 16%. Group 3 (n = 11 l) pancreatitis = l pt. or 1% (mild). Total pts. with pain = 3 pts or 2.7%. Group 4 (n = 39) panereatitis = 1 pt. or 2.5% (mild). Total pts. with pain = 3 pts. or 7%. Neither age, sex, diagnosis, length & t h e procedure or the use of medications known to cause pancreatitis were significant risk factors in causing pancreatitis. I have been doing ERCP's since 1980, so a learning curve was likely not involved. Conclusions." Instituting three technical changes in the way I performed routine and therapeutic ERCP's successfully reduced the rate of pancreatitis.
362
7"3c,4
NON-DISPOSABLE HOME-MADE MULTIPLE USE SPHINCTEROTOME: RESULTS OF A LARGE REFERRAL CENTER. A. Farca, G. de la Mora, G. Rodriguez, A. Palacios & A
PANCREATITIS COMPLICATING ENDOSCOPIC BIL1ARY SPHINCTEROTOMY (ES): A PROSPECTIVE MULTIVARIATE ANALYSIS OF RISK FACTORS INCLUDING PANCREATIC SPHINCTER HYPERTENSION (PSH). M Freeman, S Mallery, S Sherman, P Jamidar, W Silverman, M Ryan, J Curmingham, G Haber, M Herman, D Nelson and others, Hennepin County Medical Center, Minneapolis MN and the MESH study group. Risk factors for post-ES acute paacreatitis (AP) have not been comprehensively investigated. Based on data from a large prospective multicenter study of ES complications, we constmcted a multivariate model to assess independent effect of multiple risk factors on pancreatifis post-ES We then addressed the recent hypothesis that untreated PSH is responsible for the high risk of AP after ES for suspected sphincter of Oddi dysfimction (SOD). Methods: Complications were studied prospectively in consecutive pts undergoing ES at 17 institutions. Data were collected at time of procedure, prior to discharge and at 30 days. AP was defined by accepted consensus criteria. Results: Of 2,347 ES, 127 (5.4%) developed AP. Of 13 risk factors significant by univariate analysis, only six retained independent significance by multivariate analysis: suspected SOD (odds ratio 5.01), use of prcent ES (o.r. 4.34), acinarizafion (o.r. 3.97), difficult eaanulation (o.r. 3.20), >2 PD injections (o.r. 3.07), and age < 60 (o.r. 1.79). CBD diameter and use of manometry (mano) were not independently significant. 272 pts underwent biliary ES (without pancreatic ES or stent) for suspected SOD, with preceding mano in 134. Empirical ES without rnano was associated with an identical risk of AP and a trend toward more severe AP. After pancreatic rnano, despite use of aspirating catheters, incidence of AP was higher (20/82124%]) than for isolated CBD mano (4/5217.7%]), but this risk disappeared when controlling for difficulty of eaanulation. Risk of AP was the same regardless of whether PSH (basal pressure >_40mmHg)was found. Data for biliary ES for suspected SOD:
Peralta. Department of Gastroenterology & Endoscopy Unit. Hospital General "Dr. Manuel Gea Gonzfilez", SS, Mexico City. MEXICO. For the last 10 years home-made wire-guided sphincterotomes (SPT) have been used in our Unit, with good results. The high-cost of commercial equipment, makes this option attractive. A prospective study was performed. MATERIAL AND METHODS: the SPT were made usmg 5 Fr teflon tubing, with two holes, 2 and 3.5 eros from the distal tip. Braided stainless steel wiring in the cutting portion, and monofilament winng for the rest of the length were used; they were attached using a 25 gauge hollow needle. The braided wire exited through the proximal hole and attached with a curve through the distal hole. The proximal end of the wire exited throngh a latex membrat~ with a side connector for contrast injection. No handle was used, and the wire is pulled aproxunately 7 mm for cutting. The sphincterotomy is performed after eaonulation using a standard eannula and exchange using a 0.035" guide-wire (Tracer-Wilson Cook). The actual cutting is performed ha small increments using blended current and with a "pushing" rather than "arching" manoeuvre. Each SPT was thonroughly cleaned and left in Cydex for at least 20 minutes. It was discarded when no cutting was produced. All patients requiring a sphincterotomy for any established indication in the last 9 momh-period were included. Length of the sphincterotomy in mm, was noted. Complications were noted according m previous criteria (Cotton, 1990). RESULTS: 108 wire-guided sphincterotomies were performed in 37 men and 71 women; indications were: 86 common bile duct stones, 8 sphincter of Oddi dysfunction and 14 bile duct cancers. Mean length of sphiactemtomy was 1.2mm (7-20ram). Five cases of climcal pancreatitis developed, only 1 severe, 3 cases of hemorrhage ensued, requinng local adrenaline injection, 1 case required transfusion of 3 blood units, no surgery was required; I case of transient bacterenua developed and resolved with no further complications. There were no deaths. Sphineterotomes could be used for an average of 21.6 procedures (17 - 26) before beeing discarded. CONCLUSIONS: Home-made SIT are very effective and can be easily manufactured. The use of a braided wire in the cutting segment further enhances tbe life of the SPT.
V O L U M E 43, NO. 4, 1996
[ManOyes, Pancreatitis Severe AP I jAr PS_H_H Pancreatitis15 of 62 (25.0%)(24"2%) No " 28of138(20.3%) 5(3.6%) ]Pb:Sentt 5 24 of 134 (17.9%) 1 (0.8%) of 20 * CBD, PD or both Conclusions: Suspected SOD was the most potent risk factor identified for pancreatitis post-ES. Other independent risk factors included use of precut, difficult cannulation, repeated or acinarized pancreatography, and young age. Pancreatitis following ES for suspected SOD cannot be explained by PSH or use of manometry. The widespread use of empirical ES based solely on clinical suspicion of SOD has to be questioned, given its high risk and uncertain benefit.
GASTROINTESTINAL ENDOSCOPY
381
363
FREQUENCY OF ABNORMAL BILIARY AND PANCREATIC BASAL SPHINCTER PRESSURE AT SPHINCTER OF ODDI MANOMETRY (SOM) IN 463 PATIENTS. ~ , Stuart Sherman, Lois Bucksot, Dee Earle, Michael Rusche, Klaus Gottlieb, Glen Lehman. Indiana University Medical Center, Indianapolis, IN. 9 Sphincter of Oddi dysfunction can be fully classified and detected only if both the pancreatic and biliary portions of the sphincter are simultaneously studied. METHODS: From 1993-5, SOM was successfully performed on both the pancreatic and bile ducts in 463 patients who had idiopathic pancreatitis or pain suggestive o f a pancreatobiliary origin. One to three station pull throughs were done in each duct using the WilsonCook aspirating triple lumen catheter perfused at .25 mi/min/lumen. The basal sphincter pressure was determined for each lead and averaged for all pull throughs for that duct. A basal sphincter pressure > 40 mmHg was considered abnormal. Phasic waves were not tallied. RESULTS:
IMPROVEMENT IN POST-ERCP PANCREATITIS OCCURRED IN A COMMUNITY PRACTICE FOLLOWING A TECHNIQUE CHANGE Mark S. Feldman, Memorial and St. Elizabeth's Hospitals, Belleville, IIi Introduction: The frequency of post-ERCP pancreatitis in my private practice was examined before and after a change in technique occurred. In mid July 1994, I approached ERCP's differently in three ways. This included: (a) the liberal use of a precut papillotomy (use after 15 mins. of failed cannulation by a standard catheter), (b) I abandoned blind probing with guidewires, and (c) technically difficult cases were kept NPO until the following morning. I did a chart review for one year before and one year after the technical changes took place. Method: All patients in my practice with a CPT code for ERCP between 7/15/93 and 7/i5/95 were entered into a database. Cases before 7/15/94 (old technique) were in group 1 (no sphincterotomy) or group 2 (sphincterotomy). Cases after that date (new technique) were in group 3 (no sphincterotomy) or group 4 (sphincterotomy). All outpatient and inpatient charts were reviewed by hand by myself. 'Mild' pancreatitis = abdominal pain and elevated amylase ever 48 hrs, moderate = pain over 4 days, and severe = pain over 7 days. Patients were labeled as having nonpanereatitis pain for symptoms lasting over 24 hrs.
PTS. WITHABNORMALBASAL SPHINCTERPRESSURE (%) Prior Sphincter Therapy Yes (n=183)
PancreasAlone
BiliaryAlone
Both
Total
72 (39%)
2 (1%)
16 (9%)
90 (49%)
.No (n=280)
52 (19%) 25 (9%) 76 (27%) 153 (55%) SUMMARY: 1) Basal sphincter pressure abnormalities are present at SOM in approximately one half of thoroughly studied patients in our ERCP unit. 2) Among the 153 previously untreated patients with an abnormal.basal pressure, 76 (50%) had elevation of both the biliary and pancreatic sphincter segments. 3) Concordance between biliary and pancreatic (both normal or abnormal) basal sphincter pressure for previously untreated patients was 73%. 4) After biliary sphincterotomy, symptomatic patients have a high frequency of pancreatic basal sphincter abnormalities. CONCLUSION: Both pancreatic and biliary portions of the sphincter of Oddi must be evaluated to fully define sphincter dysfunction.
and under" 48 h r s . Results:_ Patient groups were identical for age, sex, and diagnosis. Group 1 (n = 116) pancreatitis = 8 pts. or 6.9% (4 mild, 3 moderate, 1 severe). Total patients with abdominal pain = 11 pts. or 9.4%. Group 2 (n = 50) pancreatitis = 2 pts. or 4% (both severe). Total pts. with pain = 8 pts. or 16%. Group 3 (n = 11 l) pancreatitis = l pt. or 1% (mild). Total pts. with pain = 3 pts or 2.7%. Group 4 (n = 39) panereatitis = 1 pt. or 2.5% (mild). Total pts. with pain = 3 pts. or 7%. Neither age, sex, diagnosis, length & t h e procedure or the use of medications known to cause pancreatitis were significant risk factors in causing pancreatitis. I have been doing ERCP's since 1980, so a learning curve was likely not involved. Conclusions." Instituting three technical changes in the way I performed routine and therapeutic ERCP's successfully reduced the rate of pancreatitis.
362
7"3c,4
NON-DISPOSABLE HOME-MADE MULTIPLE USE SPHINCTEROTOME: RESULTS OF A LARGE REFERRAL CENTER. A. Farca, G. de la Mora, G. Rodriguez, A. Palacios & A
PANCREATITIS COMPLICATING ENDOSCOPIC BIL1ARY SPHINCTEROTOMY (ES): A PROSPECTIVE MULTIVARIATE ANALYSIS OF RISK FACTORS INCLUDING PANCREATIC SPHINCTER HYPERTENSION (PSH). M Freeman, S Mallery, S Sherman, P Jamidar, W Silverman, M Ryan, J Curmingham, G Haber, M Herman, D Nelson and others, Hennepin County Medical Center, Minneapolis MN and the MESH study group. Risk factors for post-ES acute paacreatitis (AP) have not been comprehensively investigated. Based on data from a large prospective multicenter study of ES complications, we constmcted a multivariate model to assess independent effect of multiple risk factors on pancreatifis post-ES We then addressed the recent hypothesis that untreated PSH is responsible for the high risk of AP after ES for suspected sphincter of Oddi dysfimction (SOD). Methods: Complications were studied prospectively in consecutive pts undergoing ES at 17 institutions. Data were collected at time of procedure, prior to discharge and at 30 days. AP was defined by accepted consensus criteria. Results: Of 2,347 ES, 127 (5.4%) developed AP. Of 13 risk factors significant by univariate analysis, only six retained independent significance by multivariate analysis: suspected SOD (odds ratio 5.01), use of prcent ES (o.r. 4.34), acinarizafion (o.r. 3.97), difficult eaanulation (o.r. 3.20), >2 PD injections (o.r. 3.07), and age < 60 (o.r. 1.79). CBD diameter and use of manometry (mano) were not independently significant. 272 pts underwent biliary ES (without pancreatic ES or stent) for suspected SOD, with preceding mano in 134. Empirical ES without rnano was associated with an identical risk of AP and a trend toward more severe AP. After pancreatic rnano, despite use of aspirating catheters, incidence of AP was higher (20/82124%]) than for isolated CBD mano (4/5217.7%]), but this risk disappeared when controlling for difficulty of eaanulation. Risk of AP was the same regardless of whether PSH (basal pressure >_40mmHg)was found. Data for biliary ES for suspected SOD:
Peralta. Department of Gastroenterology & Endoscopy Unit. Hospital General "Dr. Manuel Gea Gonzfilez", SS, Mexico City. MEXICO. For the last 10 years home-made wire-guided sphincterotomes (SPT) have been used in our Unit, with good results. The high-cost of commercial equipment, makes this option attractive. A prospective study was performed. MATERIAL AND METHODS: the SPT were made usmg 5 Fr teflon tubing, with two holes, 2 and 3.5 eros from the distal tip. Braided stainless steel wiring in the cutting portion, and monofilament winng for the rest of the length were used; they were attached using a 25 gauge hollow needle. The braided wire exited through the proximal hole and attached with a curve through the distal hole. The proximal end of the wire exited throngh a latex membrat~ with a side connector for contrast injection. No handle was used, and the wire is pulled aproxunately 7 mm for cutting. The sphincterotomy is performed after eaonulation using a standard eannula and exchange using a 0.035" guide-wire (Tracer-Wilson Cook). The actual cutting is performed ha small increments using blended current and with a "pushing" rather than "arching" manoeuvre. Each SPT was thonroughly cleaned and left in Cydex for at least 20 minutes. It was discarded when no cutting was produced. All patients requiring a sphincterotomy for any established indication in the last 9 momh-period were included. Length of the sphincterotomy in mm, was noted. Complications were noted according m previous criteria (Cotton, 1990). RESULTS: 108 wire-guided sphincterotomies were performed in 37 men and 71 women; indications were: 86 common bile duct stones, 8 sphincter of Oddi dysfunction and 14 bile duct cancers. Mean length of sphiactemtomy was 1.2mm (7-20ram). Five cases of climcal pancreatitis developed, only 1 severe, 3 cases of hemorrhage ensued, requinng local adrenaline injection, 1 case required transfusion of 3 blood units, no surgery was required; I case of transient bacterenua developed and resolved with no further complications. There were no deaths. Sphineterotomes could be used for an average of 21.6 procedures (17 - 26) before beeing discarded. CONCLUSIONS: Home-made SIT are very effective and can be easily manufactured. The use of a braided wire in the cutting segment further enhances tbe life of the SPT.
V O L U M E 43, NO. 4, 1996
[ManOyes, Pancreatitis Severe AP I jAr PS_H_H Pancreatitis15 of 62 (25.0%)(24"2%) No " 28of138(20.3%) 5(3.6%) ]Pb:Sentt 5 24 of 134 (17.9%) 1 (0.8%) of 20 * CBD, PD or both Conclusions: Suspected SOD was the most potent risk factor identified for pancreatitis post-ES. Other independent risk factors included use of precut, difficult cannulation, repeated or acinarized pancreatography, and young age. Pancreatitis following ES for suspected SOD cannot be explained by PSH or use of manometry. The widespread use of empirical ES based solely on clinical suspicion of SOD has to be questioned, given its high risk and uncertain benefit.
GASTROINTESTINAL ENDOSCOPY
381