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Multicenter randomized trial of 10 French versus 11.5 French plastic stents for malignant bile duct obstruction
ERCP-BILIARY 421
"['423
MULTICENTER RANDOMIZED TRIAL OF 10 FRENCH VERSUS 11.5 FRENCH PLASTIC STENTS FOR MALIGNANT BILE DUCT OBSTRUCTION. ~;. Sherman, G. Lehman, D. Earle, E. Lazaridis, J. Frakes, J. Johanson, T. Qaseem, D. Howell, Indiana University Medical Center, Indianapolis, IN; Rockford GE Associates, Rockford, IL; Maine Medical Center, Portland, ME Endoscopic placement of a plastic stent is an accepted palliative therapy for malignant bile duct obstruction. The aims of this multicenter study are to compare the rates of stent occlusion, clinical response rates, technical success rates, and patient survival in patients randomized to a 10 French or a 11.5 French plastic stent. METHODS: The study population consists of 212 patients (122 M, 90 F; median age, 68 years); 46 had hilar and 166 had common duct obstruction. Tumor types included pancreatic (56%), bile duct (22%), metastatic (13%), gallbladder (4%), and other (5 %). Following guidewire advancement proximal to the stricture, the patient was randomized to a 10 French or a t 1.5 French biliary stent. Previously stented patients were randomized separately and are not included m this report. Patients were prospectively followed up (F/U) every 1-2 months to assess for symptoms of stent occlusion and to determine the clinical response rate. Stent related interventions and hospital days resulting from stent dysfunction were tallied. The change in total bilirubin between baseline and 30 day post stenting was compared. The groups were similar with regard to age, tumor type, tumor location, and ha~line hilinthin. RF.qlILTS: _ IOF ~.=t06) ~1.5v (n=1O6) P value
Early (g30 days) stent occlusion (6% vs 4%), migration (1% vs 1%), and death (4% vs 13%) were similar for the two groups. SUMMARY: The technical success rate, clinical response rate, stent occlusion rate, number of stent-related interventions and hospital days, and patient survival were similar for the 10 French and 11.5 French stent groups. CONCLUSION: These results suggest that the theoretical advantages of longer term patency of the 11.5 French stent are not seen clinically. This study is ongoing.
CALCIUM BILIRUBINATE CRYSTALS ARE AN INDICATOR OF SPHINCTER OF ODDI DYSFUNCTION IN PATIENTS WITH GALLBLADDER IN SITU AND BILIARY TYPE PAIN. T. Shiben, A. Thomas, G.J. Brodmerkel, Jr., R.M. Agrawal, Division of Gastroenterology, Allegheny General Hospital/Allegheny Campus, The Medical College of Pennsylvania and Hahnemunn University, Pittsburgh, PA Background and Aim: Other than sphincter of Oddi munometry (SOM), objective diagnostic criteria for sphincter of Oddi dysfunction (SOD) in patients presenting with biliary pain as the exclusive finding are lacking. A limited number of diagnostic tests arc available for identifying these patients, and sparse data exist on the role microlithiasis plays hr these patients. The aim of our study was to determine the incidence of SOD in patients who have bitiary type pain with gallbladder (GB) in situ"and mierolithiasis. ,M~thods: Review of records revealed 181 patients who underwent sphincter of Oddi munometry for unexplained biliary type pain. Forty-four patients had undergone prior biliary drainage, 33 of whom had GB in situ with no evidence of stones on abdominal sonogram and/or CT scan and positive crystal analysis (26-F, 7-M; mean age was 44 yrs; range 15-77). All patients underwent standard biliary SOM examination. SOD was defined as basal pressure >40 mml-lg, phasic pressure >180 mmHg, tachyoddia (>8 waves/rain.) or paradoxical response to cholecystokimn (CCK). Bile was collected for crystal analysis after iv CCK (0.04 mcg/kg) and examined under light and polarizing microscope after eentrifugntion at 2000 rpm for 15 minutes. Results: Based on Geenen criteria, all 33 patients were classified as Type 111. Crystal analysis revealed 13 patients with calcium bilimbinate crystals (CbC), 2 with cholesterol crystals (CC) and 18 patients with both CbC and CC present. Of the 33 patients, 24 (73%) had SOD by SOM. Twenty-one patients (88%) had basal pressures > 40 mmHg while three (12%) had a paradoxical response to CCK. Nine of the 33 patients (27%) had normal SOM. Mierolithiasis CbC (:C CbC & CC _Total Normal SOM 3 (23%) 1(50%) 5 (27%) 9 (27%) SOD 10(77%) I (50~ 13 (73%) 24 (73%)* *Test of proportion against 0.50: p< 0.01. Conclusions: The incidence of SOD is high in patients with GB in situ who present with Geenen type llI biliary pain and have microlithiasis on analysis. The presence of CbC appears to be a strong indicator of SOD in this group of patients. The pathogenesis of this interesting association remains to be elucidated.
~422
"[-424
CCK-SONOGRAM IS A USEFUL INDICATOR OF SPHINCTER OF ODDI DYSFUNCTION. R. Shiben, T. Shiben, G.J. Brodmerkel, Jr, R.M. Agrawal, Dept. Of Radiology, Division of Gastroenterology, Allegheny General Hospital/Allegheny Campus, The Medical College of Pennsylvania and Hahnemann University, Pittsburgh, PA .Background and Aim: Sphincter ofOddi manometry (SOM) is the gold standard diagnostic test for sphincter of Oddi dysfunction (SOD) in patients presenting with biliary pain as the exclusive finding. However, non-invasive tests available for diagnosing these patients are limited. The role CCKsonograms (CCK-U/S) play in these patients remains undefined. Our aim was to determine the diagnostic utility of CCK-U/S for SOD in patients presenting solely with biliary type pain. Methods: Review of reeords revealed 62 patients who underwent CCK-U/S for evaluation of unexplained biliary type pain. Twenty-three of these patients subsequently underwent standard biliary SOM examination (mean age 44 yrs; range 16-61; 20-F. 3-M). All 23 patients were classified as Geenen Type III. SOD was defined as basal pressure >40 mmHg, phasic pressure > 1go mmHg, tachyoddia (>8 waves/min.) or paradoxical response to CCK Sonogram measurements of the mid common bile duct diameter were obtained immediately pre- and post-intra, cnous CCK (0.04 meg&g). Abnormal CCK-U/S results are defined as an increase in duct size or no change in duct size after CCK administration. Normal CCK-U/S results are defined as a decrease in duct size post CCK. Results: CCK-U/S result Normal Abnormal Normal SOM 10 (100%)* 0 (0%~ SOD 3 (23%)* 10 (77%)* * p< 0.001 Five of the ten patients with SOD and abnormal CCK-U/S had an increase in the CBD diameter while the remaining five had no significant change. Ten of 13 patients with SOD had elevated basal pressures, and 3 (13%) had a paradoxical response to CCK; all 3 had abnormal CCK-U/S. Conclusion: CCK-U/S is a non-invasive diagnostic study which can identify SOD in patients with Geenen type III biliary pain.
CALCIUM BILIRUBINATE CRYSTALS ARE ASSOCIATED W I T H AN ABNORMAL GALLBLADDER E J E C T I O N FRACTION. T. Shiben, A. Thomas, IL Shiben, 1L Carter, G.J. Brodmerkel, Jr., 1LM. Agrawal. Division of Gastroenterology, Allegheny General Hospital/Allegheny Campus, The Medical College of Pennsylvania and Hahnemann University, Pittsburgh, PA. Background and Aim: Recent evidence has suggested a link between microlithiasis and abnormal gallbladder ejection fraction (GB EF). Data are lacking regarding the type ofmicrocalculi associated with abnormal GB EF. The aim of our study was to determine whether a particular type of crystal is more frequently associated with abnormal GB EF. Methods: Seventy-eight patients with GB in situ underwent biliary crystal analysis over a six month period for the evaluation ofbiliary type pain. Bile was collected for crystal analysis after intravenous cholecystokinin (CCK) administration (0.04 mcg/kg) and examined under light and polarizing microscopy after centrifugation at 2000 rpm for 15 minutes. The presence of either calcium bilimbinate (CbC) or cholesterol crystals (CC) was recorded. Forty-eight of these patients (33-F, 15-M; mean age was 46 yrs; range 15-.77) had CCK-stimulated quantitative scintigraphy (CCK HIDA) to calculate the GB EF. CCK (0.04 mcg/kg) was infused at peak GB concentration activity, An abnormal GB ejection fraction was defined as < 50%. Results: Twelve (25%) of the patients had a normal EF by CCK HIDA while 36 (75%) had a low EF. The bUiary drainage results are as follows: M croanalysis CbC C__CC CbC & CC Normal EF. 2 (10%) 4 (50%) 4 (31%)** 2 (29%) Abnormal EF 18 (90o,4)* 4 (50%) 9 (69%) 5 (71%) *Test of proportion against 0.50: p< 0.001 **Of interest, two of the four patients with both CbC and CC and a normal EF were noted to have predominantly C C Conclusion: In patients with biliary type pain, the presence of CbC is associated with an abnormal GB EF.
T~hnieal Sucer I~illrubin Deere.asr 9 Days to Stent Failure
99.1% 7.9 mg/dl
96.3% 10.1 mg/dl
,21 ,07 ,32
175
252
3 (3%)
1 (1%)
,62
50 (47%)
48 (45%)
,89
Stcr~ Related Hosp. Days (Mean)
1.6
1.5
.87
Stcnt Related Interventions (Mean)
.66
.51
,40
143
172
.41
Stont Migration Death Before Occlusion
_Median Patient Survival Days
396
GASTROINTESTINAL ENDOSCOPY
VOLUME 43, NO. 4, 1996
"['423
MULTICENTER RANDOMIZED TRIAL OF 10 FRENCH VERSUS 11.5 FRENCH PLASTIC STENTS FOR MALIGNANT BILE DUCT OBSTRUCTION. ~;. Sherman, G. Lehman, D. Earle, E. Lazaridis, J. Frakes, J. Johanson, T. Qaseem, D. Howell, Indiana University Medical Center, Indianapolis, IN; Rockford GE Associates, Rockford, IL; Maine Medical Center, Portland, ME Endoscopic placement of a plastic stent is an accepted palliative therapy for malignant bile duct obstruction. The aims of this multicenter study are to compare the rates of stent occlusion, clinical response rates, technical success rates, and patient survival in patients randomized to a 10 French or a 11.5 French plastic stent. METHODS: The study population consists of 212 patients (122 M, 90 F; median age, 68 years); 46 had hilar and 166 had common duct obstruction. Tumor types included pancreatic (56%), bile duct (22%), metastatic (13%), gallbladder (4%), and other (5 %). Following guidewire advancement proximal to the stricture, the patient was randomized to a 10 French or a t 1.5 French biliary stent. Previously stented patients were randomized separately and are not included m this report. Patients were prospectively followed up (F/U) every 1-2 months to assess for symptoms of stent occlusion and to determine the clinical response rate. Stent related interventions and hospital days resulting from stent dysfunction were tallied. The change in total bilirubin between baseline and 30 day post stenting was compared. The groups were similar with regard to age, tumor type, tumor location, and ha~line hilinthin. RF.qlILTS: _ IOF ~.=t06) ~1.5v (n=1O6) P value
Early (g30 days) stent occlusion (6% vs 4%), migration (1% vs 1%), and death (4% vs 13%) were similar for the two groups. SUMMARY: The technical success rate, clinical response rate, stent occlusion rate, number of stent-related interventions and hospital days, and patient survival were similar for the 10 French and 11.5 French stent groups. CONCLUSION: These results suggest that the theoretical advantages of longer term patency of the 11.5 French stent are not seen clinically. This study is ongoing.
CALCIUM BILIRUBINATE CRYSTALS ARE AN INDICATOR OF SPHINCTER OF ODDI DYSFUNCTION IN PATIENTS WITH GALLBLADDER IN SITU AND BILIARY TYPE PAIN. T. Shiben, A. Thomas, G.J. Brodmerkel, Jr., R.M. Agrawal, Division of Gastroenterology, Allegheny General Hospital/Allegheny Campus, The Medical College of Pennsylvania and Hahnemunn University, Pittsburgh, PA Background and Aim: Other than sphincter of Oddi munometry (SOM), objective diagnostic criteria for sphincter of Oddi dysfunction (SOD) in patients presenting with biliary pain as the exclusive finding are lacking. A limited number of diagnostic tests arc available for identifying these patients, and sparse data exist on the role microlithiasis plays hr these patients. The aim of our study was to determine the incidence of SOD in patients who have bitiary type pain with gallbladder (GB) in situ"and mierolithiasis. ,M~thods: Review of records revealed 181 patients who underwent sphincter of Oddi munometry for unexplained biliary type pain. Forty-four patients had undergone prior biliary drainage, 33 of whom had GB in situ with no evidence of stones on abdominal sonogram and/or CT scan and positive crystal analysis (26-F, 7-M; mean age was 44 yrs; range 15-77). All patients underwent standard biliary SOM examination. SOD was defined as basal pressure >40 mml-lg, phasic pressure >180 mmHg, tachyoddia (>8 waves/rain.) or paradoxical response to cholecystokimn (CCK). Bile was collected for crystal analysis after iv CCK (0.04 mcg/kg) and examined under light and polarizing microscope after eentrifugntion at 2000 rpm for 15 minutes. Results: Based on Geenen criteria, all 33 patients were classified as Type 111. Crystal analysis revealed 13 patients with calcium bilimbinate crystals (CbC), 2 with cholesterol crystals (CC) and 18 patients with both CbC and CC present. Of the 33 patients, 24 (73%) had SOD by SOM. Twenty-one patients (88%) had basal pressures > 40 mmHg while three (12%) had a paradoxical response to CCK. Nine of the 33 patients (27%) had normal SOM. Mierolithiasis CbC (:C CbC & CC _Total Normal SOM 3 (23%) 1(50%) 5 (27%) 9 (27%) SOD 10(77%) I (50~ 13 (73%) 24 (73%)* *Test of proportion against 0.50: p< 0.01. Conclusions: The incidence of SOD is high in patients with GB in situ who present with Geenen type llI biliary pain and have microlithiasis on analysis. The presence of CbC appears to be a strong indicator of SOD in this group of patients. The pathogenesis of this interesting association remains to be elucidated.
~422
"[-424
CCK-SONOGRAM IS A USEFUL INDICATOR OF SPHINCTER OF ODDI DYSFUNCTION. R. Shiben, T. Shiben, G.J. Brodmerkel, Jr, R.M. Agrawal, Dept. Of Radiology, Division of Gastroenterology, Allegheny General Hospital/Allegheny Campus, The Medical College of Pennsylvania and Hahnemann University, Pittsburgh, PA .Background and Aim: Sphincter ofOddi manometry (SOM) is the gold standard diagnostic test for sphincter of Oddi dysfunction (SOD) in patients presenting with biliary pain as the exclusive finding. However, non-invasive tests available for diagnosing these patients are limited. The role CCKsonograms (CCK-U/S) play in these patients remains undefined. Our aim was to determine the diagnostic utility of CCK-U/S for SOD in patients presenting solely with biliary type pain. Methods: Review of reeords revealed 62 patients who underwent CCK-U/S for evaluation of unexplained biliary type pain. Twenty-three of these patients subsequently underwent standard biliary SOM examination (mean age 44 yrs; range 16-61; 20-F. 3-M). All 23 patients were classified as Geenen Type III. SOD was defined as basal pressure >40 mmHg, phasic pressure > 1go mmHg, tachyoddia (>8 waves/min.) or paradoxical response to CCK Sonogram measurements of the mid common bile duct diameter were obtained immediately pre- and post-intra, cnous CCK (0.04 meg&g). Abnormal CCK-U/S results are defined as an increase in duct size or no change in duct size after CCK administration. Normal CCK-U/S results are defined as a decrease in duct size post CCK. Results: CCK-U/S result Normal Abnormal Normal SOM 10 (100%)* 0 (0%~ SOD 3 (23%)* 10 (77%)* * p< 0.001 Five of the ten patients with SOD and abnormal CCK-U/S had an increase in the CBD diameter while the remaining five had no significant change. Ten of 13 patients with SOD had elevated basal pressures, and 3 (13%) had a paradoxical response to CCK; all 3 had abnormal CCK-U/S. Conclusion: CCK-U/S is a non-invasive diagnostic study which can identify SOD in patients with Geenen type III biliary pain.
CALCIUM BILIRUBINATE CRYSTALS ARE ASSOCIATED W I T H AN ABNORMAL GALLBLADDER E J E C T I O N FRACTION. T. Shiben, A. Thomas, IL Shiben, 1L Carter, G.J. Brodmerkel, Jr., 1LM. Agrawal. Division of Gastroenterology, Allegheny General Hospital/Allegheny Campus, The Medical College of Pennsylvania and Hahnemann University, Pittsburgh, PA. Background and Aim: Recent evidence has suggested a link between microlithiasis and abnormal gallbladder ejection fraction (GB EF). Data are lacking regarding the type ofmicrocalculi associated with abnormal GB EF. The aim of our study was to determine whether a particular type of crystal is more frequently associated with abnormal GB EF. Methods: Seventy-eight patients with GB in situ underwent biliary crystal analysis over a six month period for the evaluation ofbiliary type pain. Bile was collected for crystal analysis after intravenous cholecystokinin (CCK) administration (0.04 mcg/kg) and examined under light and polarizing microscopy after centrifugation at 2000 rpm for 15 minutes. The presence of either calcium bilimbinate (CbC) or cholesterol crystals (CC) was recorded. Forty-eight of these patients (33-F, 15-M; mean age was 46 yrs; range 15-.77) had CCK-stimulated quantitative scintigraphy (CCK HIDA) to calculate the GB EF. CCK (0.04 mcg/kg) was infused at peak GB concentration activity, An abnormal GB ejection fraction was defined as < 50%. Results: Twelve (25%) of the patients had a normal EF by CCK HIDA while 36 (75%) had a low EF. The bUiary drainage results are as follows: M croanalysis CbC C__CC CbC & CC Normal EF. 2 (10%) 4 (50%) 4 (31%)** 2 (29%) Abnormal EF 18 (90o,4)* 4 (50%) 9 (69%) 5 (71%) *Test of proportion against 0.50: p< 0.001 **Of interest, two of the four patients with both CbC and CC and a normal EF were noted to have predominantly C C Conclusion: In patients with biliary type pain, the presence of CbC is associated with an abnormal GB EF.
T~hnieal Sucer I~illrubin Deere.asr 9 Days to Stent Failure
99.1% 7.9 mg/dl
96.3% 10.1 mg/dl
,21 ,07 ,32
175
252
3 (3%)
1 (1%)
,62
50 (47%)
48 (45%)
,89
Stcr~ Related Hosp. Days (Mean)
1.6
1.5
.87
Stcnt Related Interventions (Mean)
.66
.51
,40
143
172
.41
Stont Migration Death Before Occlusion
_Median Patient Survival Days
396
GASTROINTESTINAL ENDOSCOPY
VOLUME 43, NO. 4, 1996