Multicenter randomized trial of 10 French versus 11.5 French plastic stents for malignant bile duct obstruction

Stuart Sherman, Glen Lehman, D. Earle, E. Lazaridis, J. Frakes, J. Johanson, T. Qaseem, D. Howell

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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 11.5 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 baseline bilirubin. RESULTS: 10F (n=106) 11.5F (n=106) P value Technical Success 99.1% 96.3% .21 Bilirubin Decrease 7.9 mg/dl 10.1 mg/dl .07 Days to Stent Failure 175 252 .32 Stent Migration 3(3%) 1(1%) .62 Death Before Occlusion 50(47%) 48(45%) .89 Stent Related Hosp. Days (Mean) 1.6 1.5 .87 Stent Related Interventions (Mean) .66 .51 .40 Median Patient Survival Days 143 172 .41 Early (≤30 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.

Original languageEnglish
Pages (from-to)396
Number of pages1
JournalGastrointestinal Endoscopy
Volume43
Issue number4
StatePublished - 1996
Externally publishedYes

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Cholestasis
Plastics
Multicenter Studies
Stents
Bilirubin
Neoplasms
Survival
Bile Ducts
Gallbladder
Palliative Care

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Multicenter randomized trial of 10 French versus 11.5 French plastic stents for malignant bile duct obstruction. / Sherman, Stuart; Lehman, Glen; Earle, D.; Lazaridis, E.; Frakes, J.; Johanson, J.; Qaseem, T.; Howell, D.

In: Gastrointestinal Endoscopy, Vol. 43, No. 4, 1996, p. 396.

Research output: Contribution to journalArticle

Sherman, S, Lehman, G, Earle, D, Lazaridis, E, Frakes, J, Johanson, J, Qaseem, T & Howell, D 1996, 'Multicenter randomized trial of 10 French versus 11.5 French plastic stents for malignant bile duct obstruction', Gastrointestinal Endoscopy, vol. 43, no. 4, pp. 396.
Sherman, Stuart ; Lehman, Glen ; Earle, D. ; Lazaridis, E. ; Frakes, J. ; Johanson, J. ; Qaseem, T. ; Howell, D. / Multicenter randomized trial of 10 French versus 11.5 French plastic stents for malignant bile duct obstruction. In: Gastrointestinal Endoscopy. 1996 ; Vol. 43, No. 4. pp. 396.
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title = "Multicenter randomized trial of 10 French versus 11.5 French plastic stents for malignant bile duct obstruction",
abstract = "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 11.5 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 baseline bilirubin. RESULTS: 10F (n=106) 11.5F (n=106) P value Technical Success 99.1{\%} 96.3{\%} .21 Bilirubin Decrease 7.9 mg/dl 10.1 mg/dl .07 Days to Stent Failure 175 252 .32 Stent Migration 3(3{\%}) 1(1{\%}) .62 Death Before Occlusion 50(47{\%}) 48(45{\%}) .89 Stent Related Hosp. Days (Mean) 1.6 1.5 .87 Stent Related Interventions (Mean) .66 .51 .40 Median Patient Survival Days 143 172 .41 Early (≤30 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.",
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T1 - Multicenter randomized trial of 10 French versus 11.5 French plastic stents for malignant bile duct obstruction

AU - Sherman, Stuart

AU - Lehman, Glen

AU - Earle, D.

AU - Lazaridis, E.

AU - Frakes, J.

AU - Johanson, J.

AU - Qaseem, T.

AU - Howell, D.

PY - 1996

Y1 - 1996

N2 - 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 11.5 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 baseline bilirubin. RESULTS: 10F (n=106) 11.5F (n=106) P value Technical Success 99.1% 96.3% .21 Bilirubin Decrease 7.9 mg/dl 10.1 mg/dl .07 Days to Stent Failure 175 252 .32 Stent Migration 3(3%) 1(1%) .62 Death Before Occlusion 50(47%) 48(45%) .89 Stent Related Hosp. Days (Mean) 1.6 1.5 .87 Stent Related Interventions (Mean) .66 .51 .40 Median Patient Survival Days 143 172 .41 Early (≤30 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.

AB - 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 11.5 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 baseline bilirubin. RESULTS: 10F (n=106) 11.5F (n=106) P value Technical Success 99.1% 96.3% .21 Bilirubin Decrease 7.9 mg/dl 10.1 mg/dl .07 Days to Stent Failure 175 252 .32 Stent Migration 3(3%) 1(1%) .62 Death Before Occlusion 50(47%) 48(45%) .89 Stent Related Hosp. Days (Mean) 1.6 1.5 .87 Stent Related Interventions (Mean) .66 .51 .40 Median Patient Survival Days 143 172 .41 Early (≤30 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.

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