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Does leaving a main pancreatic duct stent in place reduce the incidence of precut biliary sphincterotomy (ES)-induced pancreatitis? a final analysis of a randomized prospective study
ERCP-PANCREAS
r
r
DOES LEAVING A MAIN PANCREATIC DUCT STENT IN PLACE REDUCE THE INCIDENCE OF PRECUT BILIARY SPH1NCTEROTOMY (ES)-INDUCED PANCREATITIS?: A FINAL,ANALYSIS OF A RANDOMIZED PROSPECTIVE STUDY. S. Sherman, D. Earle, L. Bucksot, P. Baute, K. Gottlieb, G. Lehman, Indiana University Medical Center, Indianapolis, IN Pancreatitis is the most common complication of precut ES. The objective of this study was to determine whether leaving a pancreatic duct stent in place following precut ES would reduce the incidence and severity of post-procedure panereatitis. METHODS: During the past 32 months, free cannulation of the bile duct for standard ES was not possible in 151 of 1,122 patients (13.5%). In 93, selective pancreatic duel cannulation was achieved and a 5-7 French, 2-2.5 cm main pancreatic duet stent was placed. Using the pancreatic stent as a guide, a needle-knife (NK) sphincterotome was used to eat 5-10 mm in the 11- 12 o'clock direction. Once access to the bile duct was obtained, the ES was usually completed using a standard s ~ . Following completion of the ES, these 93 patients were randomized to leaving the pancreatic stent in place (stent) for 7-10 days or immediate removal (stem removed). The remaining 58 who did not undergo pancreatic duct stent placement (no stent), had a NK ES performed in a similar fashion. Patients were prospectively followed up for complications. Standardized criteria were used to diagnose and grade the severity of postproecdure pancreatitis (GI Endosc 1991;37:383). RESULTS:
HOW
ES INDICATION
STENT
# PANCREATITIS/TOTAL# PATIENTS STENT NO STENT TOTAL REMOVED
Stones
0/6
1/9
1/9
2/24(8%)
~pyhincterof Oddi sfunctioa
1/24
4/19
6/19
11/62(18%)
Tumor
0/7
2/10
0/20
2/37 (5%)
Miscellar~ous
0/9
3/9
1/10
TOTAL 1/46 (2.2*/,)* 10/47 (21.3%) 8/58 (13.8%} *p ~ .004, stent vr stent removed; P ffi .836 stent vs. no stem
4/28(14%) 19/151 (12.676)
Pancreafitis was graded mild in 1 in the stent group, mild in 5 and moderate in 5 in the stem removed group, and mild in 5, moderate in 1, and severe in 2 in the no stent group. The number of pancreatic duct injections, frequency of pancreatic ecinarization, and the use of sphincter of Oddi manometry were similar for all three groups. SUMMARY: 1) Leaving a pancreatic duct stent in place following NK ES reduced the pancreatitis rate from 21.3% to 2.2%. 2) The pancreatitis rates were similar for the no stent and stent removed groups. CONCLUSION: These data suggest that placing and maintaining a pancreatic duct stent for NK ES reduces the frequency ofpostproc~ure pancreatitis. Until greater safety data are available from other centers, these techniques should be reserved for experienced endoscopists.
SAFE IS ENDOSCOPIC PANCREATIC SPHINCTEROTOMY (PS}? S. Soltanh S.K. I,o, Division of Gastroenterology, Harbor-UCLA Medical Center. UCLA School of Medicine. Torrance, California.
There is very little data on the safety of PS. AIMS: To determine the shnnterm safety of PS and to compare it to that of biliary sphincterotomy (BS). METHOD: PS technique at our institution was established and performed by a single biliary endoscopist (SKL). Needle knife cutting over a stem across the pancreatic sphincter was applied whenever technically feasible. Alternatively, a wire-guided sphincterotome was used. Major PS (MPS) was performed along the 1-2 o'clock position, minor sphincterotomy (MiS) was earned out along the 12 o'clock position. All sphincters were protected with a short stent for < 14 days. Records on all PS at our institution were reviewed. RESULTS: 69 PS were performed on 58 patients. Data was complete on 61 PS: MPS-35, MiS16, and simultaneous PS and BS (BS+PS)-10. The mean estimated vertical PS size was 5.8 mm (range 3-12 mm). 81% of the PS was performed with needle knife. 71% ofpts were female. Mean age was 45 (13-82). Indications for PS: obstructive chronic pancreatitis (49%), symptomatic pancreas divisum (26%), pancreatic sphincter dysfunction (22%), pancreatic fistula (1.5%), access for ductal biopsy (1.5%). Complications occurred in 16% of cases (1 pt. had 2 com ~italization was lor ~'r for BS+PS than for PS Talkie 1 N Pancrestitis Bleedin~ Sur$. Per~ Death Hasp days(range)i MiS 16 4 (25%) 0 0 0 0 2.8_+0.4(1-6) MPS 35 2 (6%) 3 (9%) 0 0 0 2%L0.3 (1-8)* BS+PS l0 1 (10%) l (10%) 0 0 0 4,7_+16 (1-16)* TOTAL 61 7 (11%) 4 (7%) 0 0 0 3,1!0.3 (1-16) alone (table 1) (*P=0.04, ANOVA). 18 cases involved separate sessions of BS and PS on the same pts, (table2). PS led to more complications and 1enter Table 2 Pancreatitis I Bleedin~ ISur~er~,]Perf. I Death [ Hos]~.days (range) i
I
PS 4 (22%) 1 (6%) 0 0 , 0 2.9_-+0.4(1-8)** hospitalization than BS (28% vs 7%, P=0.0001, Fisher's) (**P--0 02,ANOVA). S U M M A R Y : 1) PS was associated with 4X more complications and 2X longer hospitalization than BS, 2) simultaneous BS and PS led to longer hospital stay than PS alone, 3) all short-term complications were self-limited. C O N C L U S I O N S : PS is not as safe as BS and must be approached with caution. Its long and short-term safety profiles remain to be fully established because of limited patient experience and varying techniques.
49O
492
SPHINCTEROTOMY BY NEEDLE-KNIFE OVER PANCREATIC STEN~I TECHNIQUE LOWERS THE POST-PROCEDURE PANCREATITIS FREQUENCY AND SEVERITY 1N SPHINCTER OF ODDI DYSFUNCTION (SOD) PATIENTS. Smart Sherman. Damian Eversman, Dee Earle, Lois Buckshot. Michael Rasche, Glen Lehman, Indiana University Medical Center, Indianapolis, I/', Numerous reports show that SOD patients are at high risk for biliary sphincterotomy (BDES)-indueed pancreathis. We recently reported that needle-knife over pancreatic stent sphineterotomy (NKOPS) technique significantly lowered the pancreatitis rate in biliaty precut sphincterotomy patients (GI Endose 1994;40:124). The aim of this study was to determine whether NKOPS with pancreatic sphincterotomy (PDES) reduces the incidence of postprocedure pancreatitis compared to standard BDES. METHODS: Sirw,e adopting this techniqneroutinely, 93 patients with sphincter of Oddi manometry (SOM) documented SOD (pancreatic with or without biliary basal sphincter pressure > 40 mm Hg) underwent sphincterotomy via the NKOPS+PDES method. Pancreatic stents were polyethylene 5 French, 2 cm length with half pigtail in the duodenum. Stents dislodged spontaneously (internal flange removed) or were removed in 10 days. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis (GI Endosc 1991;37:383). This group was compared to similar patients treated by biliary sphincterotomy alone without pancreatic stenting during a 2 year interval. Patients were prospectively followed for complications as part of our Quality Assurance and Continuous Quality Improvement programs. Discharged patients were called at home 24-72 hours later to assess for complications. Precut sphincterotomy patients without stents were excluded. RESULTS:
Efficacy of pancreatic ductal lavage in management of severe pancreatitis
PANCREATITIS SEVERITY Therapy
N
Pancmatitis
Mild
Moderate
Severe
Deaths
BDES
104
29%*
19/104
5/104
5/104
0
NKOPS+PDES 93 12%* 6/93 3/93 2/93 0 * Chi Square p=.02 SUMMARY: 1) NKOPS+PDES significantly decreased the frequency ofpost-ES pancreatitis in this high risk treatment group. 2) There is a trend toward lower pancreatitis severity for the NKOPS+PDES group 3) Stents which do not spontaneously dislodge must be removed endoscopically. CONCLUSIONS: 1) These results need confirmation in other large centers before we recommend general use. 2) Stent modifications which encourage spontaneous passage need further evaluation
VOLUME 43, NO. 4, 1996
N Kanaga Sundaram, Janardhan Bollu and Frank Smith Division of Gastroenterology, Department of Medicine, UMD-New Jersey Medical School, Newark, NJ 07103 While there is good theoretical basis for treating severe pancreatitis with peritoneal lavage, the results of large clinical trials are disappointing. We report an unexpected but good outcome from a radical approach in treating severe pancreatitis. A 43 year old white male aIcoholic was admitted with severe pancreatitis with phiegmon. A large pseudocyst developed and the patient underwent cystogastrostomy in 3 weeks and was discharged in 2 weeks following full recovery. He resumed drinking and was readmitted in 4 weeks with severe pancrea-titis, leukocytosis, phlegmon and peripancreatic fluid collection. He was started on antibiotic therapy and waS transferred to NJMS-University hospital for further management. During ERCP the pancreatic duct showed evidence of acute and chronic changes but no disruption or complete obstruction. A nasopancreatic drain (NPD) was placed and a closed system was developed for lavaging the duct. The duct was flushed with 7 to 10 cc of sterile saline q 2 hr and allowed to drain by gravity. Five days later in the CAT scan there was a marked decrease in the peripacreatic fluid collection and edema of the pancreas. NPD removal resulted in recurrence of the symptoms and fluid collection in three days. Then the NPD was replaced with a sphincterotomy and the transductal lavage was continued. Based on weekly CAT scan, the frequency of flushing was gradually decreased and stopped by the third week. The NPD was removed when the pancreatogram wa~srelatively normal. The patient remained asymptomatic during the next three months. This case illustrates that the provision of drainage and flushing with volumes that the pancreatic duct could tolerate were the main factors responsible for resolution of the phlegmon and peripancreatic fluid collection. We conclude that there is a role for endoscopic management of severe acute pancreatitis and the transductal lavage if done early will abate further destruction of the pancreas and the development of cystic necrosis.
GASTROINTESTINAL ENDOSCOPY
413
r
r
DOES LEAVING A MAIN PANCREATIC DUCT STENT IN PLACE REDUCE THE INCIDENCE OF PRECUT BILIARY SPH1NCTEROTOMY (ES)-INDUCED PANCREATITIS?: A FINAL,ANALYSIS OF A RANDOMIZED PROSPECTIVE STUDY. S. Sherman, D. Earle, L. Bucksot, P. Baute, K. Gottlieb, G. Lehman, Indiana University Medical Center, Indianapolis, IN Pancreatitis is the most common complication of precut ES. The objective of this study was to determine whether leaving a pancreatic duct stent in place following precut ES would reduce the incidence and severity of post-procedure panereatitis. METHODS: During the past 32 months, free cannulation of the bile duct for standard ES was not possible in 151 of 1,122 patients (13.5%). In 93, selective pancreatic duel cannulation was achieved and a 5-7 French, 2-2.5 cm main pancreatic duet stent was placed. Using the pancreatic stent as a guide, a needle-knife (NK) sphincterotome was used to eat 5-10 mm in the 11- 12 o'clock direction. Once access to the bile duct was obtained, the ES was usually completed using a standard s ~ . Following completion of the ES, these 93 patients were randomized to leaving the pancreatic stent in place (stent) for 7-10 days or immediate removal (stem removed). The remaining 58 who did not undergo pancreatic duct stent placement (no stent), had a NK ES performed in a similar fashion. Patients were prospectively followed up for complications. Standardized criteria were used to diagnose and grade the severity of postproecdure pancreatitis (GI Endosc 1991;37:383). RESULTS:
HOW
ES INDICATION
STENT
# PANCREATITIS/TOTAL# PATIENTS STENT NO STENT TOTAL REMOVED
Stones
0/6
1/9
1/9
2/24(8%)
~pyhincterof Oddi sfunctioa
1/24
4/19
6/19
11/62(18%)
Tumor
0/7
2/10
0/20
2/37 (5%)
Miscellar~ous
0/9
3/9
1/10
TOTAL 1/46 (2.2*/,)* 10/47 (21.3%) 8/58 (13.8%} *p ~ .004, stent vr stent removed; P ffi .836 stent vs. no stem
4/28(14%) 19/151 (12.676)
Pancreafitis was graded mild in 1 in the stent group, mild in 5 and moderate in 5 in the stem removed group, and mild in 5, moderate in 1, and severe in 2 in the no stent group. The number of pancreatic duct injections, frequency of pancreatic ecinarization, and the use of sphincter of Oddi manometry were similar for all three groups. SUMMARY: 1) Leaving a pancreatic duct stent in place following NK ES reduced the pancreatitis rate from 21.3% to 2.2%. 2) The pancreatitis rates were similar for the no stent and stent removed groups. CONCLUSION: These data suggest that placing and maintaining a pancreatic duct stent for NK ES reduces the frequency ofpostproc~ure pancreatitis. Until greater safety data are available from other centers, these techniques should be reserved for experienced endoscopists.
SAFE IS ENDOSCOPIC PANCREATIC SPHINCTEROTOMY (PS}? S. Soltanh S.K. I,o, Division of Gastroenterology, Harbor-UCLA Medical Center. UCLA School of Medicine. Torrance, California.
There is very little data on the safety of PS. AIMS: To determine the shnnterm safety of PS and to compare it to that of biliary sphincterotomy (BS). METHOD: PS technique at our institution was established and performed by a single biliary endoscopist (SKL). Needle knife cutting over a stem across the pancreatic sphincter was applied whenever technically feasible. Alternatively, a wire-guided sphincterotome was used. Major PS (MPS) was performed along the 1-2 o'clock position, minor sphincterotomy (MiS) was earned out along the 12 o'clock position. All sphincters were protected with a short stent for < 14 days. Records on all PS at our institution were reviewed. RESULTS: 69 PS were performed on 58 patients. Data was complete on 61 PS: MPS-35, MiS16, and simultaneous PS and BS (BS+PS)-10. The mean estimated vertical PS size was 5.8 mm (range 3-12 mm). 81% of the PS was performed with needle knife. 71% ofpts were female. Mean age was 45 (13-82). Indications for PS: obstructive chronic pancreatitis (49%), symptomatic pancreas divisum (26%), pancreatic sphincter dysfunction (22%), pancreatic fistula (1.5%), access for ductal biopsy (1.5%). Complications occurred in 16% of cases (1 pt. had 2 com ~italization was lor ~'r for BS+PS than for PS Talkie 1 N Pancrestitis Bleedin~ Sur$. Per~ Death Hasp days(range)i MiS 16 4 (25%) 0 0 0 0 2.8_+0.4(1-6) MPS 35 2 (6%) 3 (9%) 0 0 0 2%L0.3 (1-8)* BS+PS l0 1 (10%) l (10%) 0 0 0 4,7_+16 (1-16)* TOTAL 61 7 (11%) 4 (7%) 0 0 0 3,1!0.3 (1-16) alone (table 1) (*P=0.04, ANOVA). 18 cases involved separate sessions of BS and PS on the same pts, (table2). PS led to more complications and 1enter Table 2 Pancreatitis I Bleedin~ ISur~er~,]Perf. I Death [ Hos]~.days (range) i
I
PS 4 (22%) 1 (6%) 0 0 , 0 2.9_-+0.4(1-8)** hospitalization than BS (28% vs 7%, P=0.0001, Fisher's) (**P--0 02,ANOVA). S U M M A R Y : 1) PS was associated with 4X more complications and 2X longer hospitalization than BS, 2) simultaneous BS and PS led to longer hospital stay than PS alone, 3) all short-term complications were self-limited. C O N C L U S I O N S : PS is not as safe as BS and must be approached with caution. Its long and short-term safety profiles remain to be fully established because of limited patient experience and varying techniques.
49O
492
SPHINCTEROTOMY BY NEEDLE-KNIFE OVER PANCREATIC STEN~I TECHNIQUE LOWERS THE POST-PROCEDURE PANCREATITIS FREQUENCY AND SEVERITY 1N SPHINCTER OF ODDI DYSFUNCTION (SOD) PATIENTS. Smart Sherman. Damian Eversman, Dee Earle, Lois Buckshot. Michael Rasche, Glen Lehman, Indiana University Medical Center, Indianapolis, I/', Numerous reports show that SOD patients are at high risk for biliary sphincterotomy (BDES)-indueed pancreathis. We recently reported that needle-knife over pancreatic stent sphineterotomy (NKOPS) technique significantly lowered the pancreatitis rate in biliaty precut sphincterotomy patients (GI Endose 1994;40:124). The aim of this study was to determine whether NKOPS with pancreatic sphincterotomy (PDES) reduces the incidence of postprocedure pancreatitis compared to standard BDES. METHODS: Sirw,e adopting this techniqneroutinely, 93 patients with sphincter of Oddi manometry (SOM) documented SOD (pancreatic with or without biliary basal sphincter pressure > 40 mm Hg) underwent sphincterotomy via the NKOPS+PDES method. Pancreatic stents were polyethylene 5 French, 2 cm length with half pigtail in the duodenum. Stents dislodged spontaneously (internal flange removed) or were removed in 10 days. Standardized criteria were used to diagnose and grade the severity of postprocedure pancreatitis (GI Endosc 1991;37:383). This group was compared to similar patients treated by biliary sphincterotomy alone without pancreatic stenting during a 2 year interval. Patients were prospectively followed for complications as part of our Quality Assurance and Continuous Quality Improvement programs. Discharged patients were called at home 24-72 hours later to assess for complications. Precut sphincterotomy patients without stents were excluded. RESULTS:
Efficacy of pancreatic ductal lavage in management of severe pancreatitis
PANCREATITIS SEVERITY Therapy
N
Pancmatitis
Mild
Moderate
Severe
Deaths
BDES
104
29%*
19/104
5/104
5/104
0
NKOPS+PDES 93 12%* 6/93 3/93 2/93 0 * Chi Square p=.02 SUMMARY: 1) NKOPS+PDES significantly decreased the frequency ofpost-ES pancreatitis in this high risk treatment group. 2) There is a trend toward lower pancreatitis severity for the NKOPS+PDES group 3) Stents which do not spontaneously dislodge must be removed endoscopically. CONCLUSIONS: 1) These results need confirmation in other large centers before we recommend general use. 2) Stent modifications which encourage spontaneous passage need further evaluation
VOLUME 43, NO. 4, 1996
N Kanaga Sundaram, Janardhan Bollu and Frank Smith Division of Gastroenterology, Department of Medicine, UMD-New Jersey Medical School, Newark, NJ 07103 While there is good theoretical basis for treating severe pancreatitis with peritoneal lavage, the results of large clinical trials are disappointing. We report an unexpected but good outcome from a radical approach in treating severe pancreatitis. A 43 year old white male aIcoholic was admitted with severe pancreatitis with phiegmon. A large pseudocyst developed and the patient underwent cystogastrostomy in 3 weeks and was discharged in 2 weeks following full recovery. He resumed drinking and was readmitted in 4 weeks with severe pancrea-titis, leukocytosis, phlegmon and peripancreatic fluid collection. He was started on antibiotic therapy and waS transferred to NJMS-University hospital for further management. During ERCP the pancreatic duct showed evidence of acute and chronic changes but no disruption or complete obstruction. A nasopancreatic drain (NPD) was placed and a closed system was developed for lavaging the duct. The duct was flushed with 7 to 10 cc of sterile saline q 2 hr and allowed to drain by gravity. Five days later in the CAT scan there was a marked decrease in the peripacreatic fluid collection and edema of the pancreas. NPD removal resulted in recurrence of the symptoms and fluid collection in three days. Then the NPD was replaced with a sphincterotomy and the transductal lavage was continued. Based on weekly CAT scan, the frequency of flushing was gradually decreased and stopped by the third week. The NPD was removed when the pancreatogram wa~srelatively normal. The patient remained asymptomatic during the next three months. This case illustrates that the provision of drainage and flushing with volumes that the pancreatic duct could tolerate were the main factors responsible for resolution of the phlegmon and peripancreatic fluid collection. We conclude that there is a role for endoscopic management of severe acute pancreatitis and the transductal lavage if done early will abate further destruction of the pancreas and the development of cystic necrosis.
GASTROINTESTINAL ENDOSCOPY
413