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Endoscopic Treatment for the Elderly with Bile Duct Stones: Is It Useful and Safe As Well As for Younger Patients?
Abstracts
M1313 Endoscopic Treatment for the Elderly with Bile Duct Stones: Is It Useful and Safe As Well As for Younger Patients? Shinji Okaniwa, Yoshiyuki Nakamura, Kumiko Shirahata, Manabu Hiraguri, Naoto Horigome, Gengo Kaneko, Yuuko Okaniwa Purpose: The incidence of elderly patients (80 years old or older) with common bile duct (CBD) stones is increasing due to the aging society. Because of the high risk of complications such as cholangitis or acute pancreatitis, the removal of CBD stones should be recommended. On the other hand, the high morbidity of the elderly is another serious problem. This study is designed to clarify the characteristics of the elderly with CBD stones and evaluate the usefulness of endoscopic treatment. Methods: In this study, we retrospectively analyzed 235 available cases with CBD stones between April 2000 and September 2006. All patients were divided into 80 years old or older (the elder group: 87 cases) and less than 80 years old (the younger group: 148 cases). First, we assessed characteristics of patients included abnormalities in liver function tests, the maximum size of stones, emergency or scheduled endoscopic examination, presence of mentally and/or physically challenged conditions, anticoagulants use and past history of gastrectomy in each group. Then we compared the success rate and complications of endoscopic treatment in the elder group with those in the younger group. Results: The incidence of abnormalities in liver function test was 90.8% in the elder group and 89.2% in the younger group. The maximum size of stones was divided into three groups: 5 mm or less, from 6 to10 mm and 11 mm or more. The incidence of each group was 20.7%, 36.8% and 42.5% in the elder group, and 33.8%, 43.9%, 22.3% in the younger group. The maximum size of stones in the elder group tended to be larger than that of the younger group. The incidence of emergency endoscopic examination and mentally and/or physically challenged condition in the elder group (48.3%, 64.4%) were statistically higher than those of the younger group (35.8%, 16.2%). The incidences of anticoagulants use and the history of gastrectomy didn’t show any statistical difference between either group. The success rate of endoscopic treatment (98.9%) and the complete removal of stones (96.6%) in the elder group didn’t show any statistical difference between those in the younger group (98.0% and 93.2%). The incidences of complications included bleeding, pancreatitis and perforation were 5.81%, 4.65% and 3.49% in the elder group, and didn’t show any statistical difference than those in the younger group (8.22%, 6.85% and 0.68%). Conclusions: Though the incidences of emergency endoscopic examination and mentally and/or physically challenged conditions were statistically higher in older patients with CBD stones, the endoscopic treatment for the elderly is safe and useful just as for younger patients.
M1314 Balloon Extended Sphincterotomy: Simple and Safe Technique to Facilitate the Management of Giant Common Bile Duct Stones Eduardo Valdivieso, Harz Carlos, Cecilia Castillo, Saenz Roque, Claudio Navarrete Introduction: Giant choledocolitiasis is still a challenging condition even for expert endoscopic surgeons. We describe and evaluate a new technique that simplifies the management of giant stones and reduce the need of lithotripsy. Aim: To describe the technique of Balloon Extended Spinchterotomy (BES) and to compare its effectiveness, efficiency and safety against conventional spinchterotomy in the management of giant common bile duct stones. Methods: Non randomized clinical trial. Once the diagnosis of giant stone has been established, a wide spinchterotomy is performed in all patients. For the BES group, hydrostatic dilatation of the papilla was performed to reach the maximum diameter of the common bile duct (up to 20 mm). Extraction of the stone using a Dormia Basket was attempted, but if failed, mechanical lithotripsy and/or stenting were carried out. Relative risks were calculated for the need of lithotripsy, the need of stent and for failure to resolve the condition in only one procedure. Data about complication was also analized. Results: 88 patients were included (44 in the conventional spinchterotomy group and 44 in the BES group). The need of more than one procedure was higher for conventional spinchterotomy group (RR Z 27,5 [IC 95% 17,34-41.52]) For this group, a higher risk of lithotripsy (RR Z 42,5 [IC 95% 33, 67-56,78]) and a higher risk of use of stents (RR Z 21, 5 [IC 95% 15,21-32,16]) was found. Bleeding was similar for both groups and there were not cases of pancreatitis or duodenal perforation in our study. Conclusion: This non randomized clinical trial suggests that BES is a safe, simple and effective technique to facilitate the treatment of giant common bile duct stones.
M1315 Do All Abnormal Intraoperative Cholangiograms Warrant ERCP? Nalini Guda, Marc F. Catalano, Susan Partington, Manuraj Rajagopal, Joseph E. Geenen Background: Laparoscopic cholecystectomy is often done for those with symptomatic cholelithiasis. In those with clinical suspicion for stones in the common bile duct (CBD), an intra operative cholangiogram (IOC) is performed and if abnormality is detected, then endoscopic retrograde cholangiopancreatography is performed. False positive rates for IOC are variable
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and this leads to unnecessary ERCPs and associated complications. Aim: 1) To identify the sensitivity and specificity of IOC compared to ERCP which is the gold standard. 2) To identify other clinical features which are associated with abnormalities of IOC so as to improve the test characteristics. Methods: The data base of a large tertiary care hospital at Milwaukee, WI was queried by ICD 9 codes for laparoscopic cholecystectomy and subjects were then cross referenced by those with ICD 9 codes for IOC and ERCP. Subjects undergoing both the procedures over the last 10 years at the same institution were included in the analysis. Indications for cholecystectomy, IOC, data from imaging studies including CT, ultrasound, liver function (LFT), and ERCP data were all recorded in a standardized data abstraction sheet. Immediate ERCP complications were recorded. Results: Sixty-four underwent lap chole with IOC and ERCP between January 1996 and December 2005. 37 (42.2%) were males. The mean age was 57 years. Half of subjects had multiple indications for Lap Chole. Indications included cholecystitis in 44 (68.8%), biliary dyskinesia in 1 (1.6%), biliary pancreatitis in 24 (37.5) and symptomatic cholelithiasis in 44 (68.8%). There was a concordance between IOC and ERCP for presence and absence of choledocholithiasis in 45 (70.3%). The sensitivity and specificity of IOC as compared to ERCP was 75.0% and 68.8%. When computation of sensitivity and specificity was limited to subjects with LFT abnormalities (elevation in Bili, alk phos and transaminases to any degree) sensitivity and specificity of IOC for detection of stones were not significantly different (Table 1). Additionally, the operating characteristics did not differ among indications for lap chole. In the six (9.4%) subjects found to have stricture of CBD on IOC, no stones were detected with ERCP. Post ERCP pancreatitis was seen in 6% and was mild. Conclusions: 1. The predictability of stones on IOC remains suboptimal. 2. Abnormal LFTs and indications for lap chole do not increase the predictive value of IOC. 3. Role of other imaging studies like MRCP needs to evaluated to avoid unnecessary ERCPs. Sensitivity
Specificity
75% 66.7%
68.8% 71%
Positive IOC Positive IOC þ Abn LFTs
M1316 An Interim Report of a Randomized Control Trial of Suprapapillary Needle Puncture vs. Needle Knife Sphincterotomy in 47 Patients Everson L. Artifon, Paulo Sakai, Atul Kumar, Shinichi Ishioka Background: Standard cannulation may fail in 10-20% of ERCP’s, entailing use of risky maneuvers such as precut for bile duct access. Precut techniques such as needle knife sphincterotomy (NKS) are associated with higher complication rates such as bleeding, perforation and pancreatitis. Our group has earlier reported a novel suprapapillary needle puncture (SNP) catheter technique. Briefly, utilizing the Seldinger technique, the area over the maximal bulge of the ampulla is punctured using a 21 G needle to access the common bile duct. Under fluoroscopy, a guidewire is passed through the needle into the CBD, the needle is withdrawn and replaced by a sphinctertome. Contrast is injected to confirm positioning in the common bile duct. We report interim outcomes of a prospective randomized trial of SNP vs. NKS. Methods: A sample size calculation indicated that 43 patients had to be enrolled in each group. To date, 47 patients with unsuccessful cannulation have been randomized to SNP (Group I) or to NKS (Group II) cannulation. SNP was performed using the Artifon catheter and NKS using precut needle knife (Boston Scientific). Data as in table was compiled, serum amylase was obtained before and 12 & 24 hrs following the procedure. Results: Cannulation rates were O83% and there were fewer total complications in the SNP group. There was a trend to fewer rates of individual complications (bleeding, pancreatitis, perforation and hypermaylasemia) in the SNP vs. NKS group. Conclusions: SNP appears to be as effective and safer then KNS for biliary access following failed ERCP cannulation.
N Time Success Indications Choledocholithiasis Pancreatic cancer Cholangioca Ampullary Ca Papillary adenoma Outcomes Pancreatitis Amylase (O3ULN) Bleeding Perforation Deaths Total complications
SNP
KNS
p
23 7 3.15 19
24 5 2.18 21
NS 0.41 NS
14 4 2 2 1
16 6 1 1 0
NS NS NS NS NS
0 2 1 0 0 3
3 4 3 2 0 12
.09 .41 .09 NS .01
Volume 65, No. 5 : 2007 GASTROINTESTINAL ENDOSCOPY AB225
M1313 Endoscopic Treatment for the Elderly with Bile Duct Stones: Is It Useful and Safe As Well As for Younger Patients? Shinji Okaniwa, Yoshiyuki Nakamura, Kumiko Shirahata, Manabu Hiraguri, Naoto Horigome, Gengo Kaneko, Yuuko Okaniwa Purpose: The incidence of elderly patients (80 years old or older) with common bile duct (CBD) stones is increasing due to the aging society. Because of the high risk of complications such as cholangitis or acute pancreatitis, the removal of CBD stones should be recommended. On the other hand, the high morbidity of the elderly is another serious problem. This study is designed to clarify the characteristics of the elderly with CBD stones and evaluate the usefulness of endoscopic treatment. Methods: In this study, we retrospectively analyzed 235 available cases with CBD stones between April 2000 and September 2006. All patients were divided into 80 years old or older (the elder group: 87 cases) and less than 80 years old (the younger group: 148 cases). First, we assessed characteristics of patients included abnormalities in liver function tests, the maximum size of stones, emergency or scheduled endoscopic examination, presence of mentally and/or physically challenged conditions, anticoagulants use and past history of gastrectomy in each group. Then we compared the success rate and complications of endoscopic treatment in the elder group with those in the younger group. Results: The incidence of abnormalities in liver function test was 90.8% in the elder group and 89.2% in the younger group. The maximum size of stones was divided into three groups: 5 mm or less, from 6 to10 mm and 11 mm or more. The incidence of each group was 20.7%, 36.8% and 42.5% in the elder group, and 33.8%, 43.9%, 22.3% in the younger group. The maximum size of stones in the elder group tended to be larger than that of the younger group. The incidence of emergency endoscopic examination and mentally and/or physically challenged condition in the elder group (48.3%, 64.4%) were statistically higher than those of the younger group (35.8%, 16.2%). The incidences of anticoagulants use and the history of gastrectomy didn’t show any statistical difference between either group. The success rate of endoscopic treatment (98.9%) and the complete removal of stones (96.6%) in the elder group didn’t show any statistical difference between those in the younger group (98.0% and 93.2%). The incidences of complications included bleeding, pancreatitis and perforation were 5.81%, 4.65% and 3.49% in the elder group, and didn’t show any statistical difference than those in the younger group (8.22%, 6.85% and 0.68%). Conclusions: Though the incidences of emergency endoscopic examination and mentally and/or physically challenged conditions were statistically higher in older patients with CBD stones, the endoscopic treatment for the elderly is safe and useful just as for younger patients.
M1314 Balloon Extended Sphincterotomy: Simple and Safe Technique to Facilitate the Management of Giant Common Bile Duct Stones Eduardo Valdivieso, Harz Carlos, Cecilia Castillo, Saenz Roque, Claudio Navarrete Introduction: Giant choledocolitiasis is still a challenging condition even for expert endoscopic surgeons. We describe and evaluate a new technique that simplifies the management of giant stones and reduce the need of lithotripsy. Aim: To describe the technique of Balloon Extended Spinchterotomy (BES) and to compare its effectiveness, efficiency and safety against conventional spinchterotomy in the management of giant common bile duct stones. Methods: Non randomized clinical trial. Once the diagnosis of giant stone has been established, a wide spinchterotomy is performed in all patients. For the BES group, hydrostatic dilatation of the papilla was performed to reach the maximum diameter of the common bile duct (up to 20 mm). Extraction of the stone using a Dormia Basket was attempted, but if failed, mechanical lithotripsy and/or stenting were carried out. Relative risks were calculated for the need of lithotripsy, the need of stent and for failure to resolve the condition in only one procedure. Data about complication was also analized. Results: 88 patients were included (44 in the conventional spinchterotomy group and 44 in the BES group). The need of more than one procedure was higher for conventional spinchterotomy group (RR Z 27,5 [IC 95% 17,34-41.52]) For this group, a higher risk of lithotripsy (RR Z 42,5 [IC 95% 33, 67-56,78]) and a higher risk of use of stents (RR Z 21, 5 [IC 95% 15,21-32,16]) was found. Bleeding was similar for both groups and there were not cases of pancreatitis or duodenal perforation in our study. Conclusion: This non randomized clinical trial suggests that BES is a safe, simple and effective technique to facilitate the treatment of giant common bile duct stones.
M1315 Do All Abnormal Intraoperative Cholangiograms Warrant ERCP? Nalini Guda, Marc F. Catalano, Susan Partington, Manuraj Rajagopal, Joseph E. Geenen Background: Laparoscopic cholecystectomy is often done for those with symptomatic cholelithiasis. In those with clinical suspicion for stones in the common bile duct (CBD), an intra operative cholangiogram (IOC) is performed and if abnormality is detected, then endoscopic retrograde cholangiopancreatography is performed. False positive rates for IOC are variable
www.giejournal.org
and this leads to unnecessary ERCPs and associated complications. Aim: 1) To identify the sensitivity and specificity of IOC compared to ERCP which is the gold standard. 2) To identify other clinical features which are associated with abnormalities of IOC so as to improve the test characteristics. Methods: The data base of a large tertiary care hospital at Milwaukee, WI was queried by ICD 9 codes for laparoscopic cholecystectomy and subjects were then cross referenced by those with ICD 9 codes for IOC and ERCP. Subjects undergoing both the procedures over the last 10 years at the same institution were included in the analysis. Indications for cholecystectomy, IOC, data from imaging studies including CT, ultrasound, liver function (LFT), and ERCP data were all recorded in a standardized data abstraction sheet. Immediate ERCP complications were recorded. Results: Sixty-four underwent lap chole with IOC and ERCP between January 1996 and December 2005. 37 (42.2%) were males. The mean age was 57 years. Half of subjects had multiple indications for Lap Chole. Indications included cholecystitis in 44 (68.8%), biliary dyskinesia in 1 (1.6%), biliary pancreatitis in 24 (37.5) and symptomatic cholelithiasis in 44 (68.8%). There was a concordance between IOC and ERCP for presence and absence of choledocholithiasis in 45 (70.3%). The sensitivity and specificity of IOC as compared to ERCP was 75.0% and 68.8%. When computation of sensitivity and specificity was limited to subjects with LFT abnormalities (elevation in Bili, alk phos and transaminases to any degree) sensitivity and specificity of IOC for detection of stones were not significantly different (Table 1). Additionally, the operating characteristics did not differ among indications for lap chole. In the six (9.4%) subjects found to have stricture of CBD on IOC, no stones were detected with ERCP. Post ERCP pancreatitis was seen in 6% and was mild. Conclusions: 1. The predictability of stones on IOC remains suboptimal. 2. Abnormal LFTs and indications for lap chole do not increase the predictive value of IOC. 3. Role of other imaging studies like MRCP needs to evaluated to avoid unnecessary ERCPs. Sensitivity
Specificity
75% 66.7%
68.8% 71%
Positive IOC Positive IOC þ Abn LFTs
M1316 An Interim Report of a Randomized Control Trial of Suprapapillary Needle Puncture vs. Needle Knife Sphincterotomy in 47 Patients Everson L. Artifon, Paulo Sakai, Atul Kumar, Shinichi Ishioka Background: Standard cannulation may fail in 10-20% of ERCP’s, entailing use of risky maneuvers such as precut for bile duct access. Precut techniques such as needle knife sphincterotomy (NKS) are associated with higher complication rates such as bleeding, perforation and pancreatitis. Our group has earlier reported a novel suprapapillary needle puncture (SNP) catheter technique. Briefly, utilizing the Seldinger technique, the area over the maximal bulge of the ampulla is punctured using a 21 G needle to access the common bile duct. Under fluoroscopy, a guidewire is passed through the needle into the CBD, the needle is withdrawn and replaced by a sphinctertome. Contrast is injected to confirm positioning in the common bile duct. We report interim outcomes of a prospective randomized trial of SNP vs. NKS. Methods: A sample size calculation indicated that 43 patients had to be enrolled in each group. To date, 47 patients with unsuccessful cannulation have been randomized to SNP (Group I) or to NKS (Group II) cannulation. SNP was performed using the Artifon catheter and NKS using precut needle knife (Boston Scientific). Data as in table was compiled, serum amylase was obtained before and 12 & 24 hrs following the procedure. Results: Cannulation rates were O83% and there were fewer total complications in the SNP group. There was a trend to fewer rates of individual complications (bleeding, pancreatitis, perforation and hypermaylasemia) in the SNP vs. NKS group. Conclusions: SNP appears to be as effective and safer then KNS for biliary access following failed ERCP cannulation.
N Time Success Indications Choledocholithiasis Pancreatic cancer Cholangioca Ampullary Ca Papillary adenoma Outcomes Pancreatitis Amylase (O3ULN) Bleeding Perforation Deaths Total complications
SNP
KNS
p
23 7 3.15 19
24 5 2.18 21
NS 0.41 NS
14 4 2 2 1
16 6 1 1 0
NS NS NS NS NS
0 2 1 0 0 3
3 4 3 2 0 12
.09 .41 .09 NS .01
Volume 65, No. 5 : 2007 GASTROINTESTINAL ENDOSCOPY AB225