- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01085747
Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis
Covered Self-expandable Metal Stents Versus Multiple Plastic Stents for Benign Biliary Stricture Caused by Chronic Pancreatitis: a Prospective Randomized Study
Visão geral do estudo
Status
Condições
Descrição detalhada
All consecutive patients admitted for ERCP and treated for benign biliary stricture caused by chronic pancreatitis are prospectively enrolled in the study.
At the initial ERCP, an endoscopic sphincterotomy will be performed and one 10 Fr plastic stent will be inserted for the initial treatment of cholestasis in all patients.Pancreatic stent will be inserted if indicated. One to three months after the initial ERCP the patients will be randomized into two groups: those who receive cSEMS and those who receive multiple plastic stents into the bile duct. For the randomization, sealed envelopes will be used. As for cSEMSs, removable cSEMSs with diameter of 10 mm will be placed. A dilation with a 8-10mm balloon will be performed before and after the stent placement to secure the stent expansion. As for plastic stents, minimum three simultaneous 10 Fr stents will be inserted after 8-10 mm balloon dilation.
After three months a further ERCP will be performed. The number of plastic stents will be increased maximally to six 10 Fr stents after dilation if possible. In the group with cSEMS, the position of the stent will be controlled.
Once the cSEMS or plastic stents have been in place for minimum six months, the stents will be removed at the last ERCP.
Follow-up
Clinical response (adequate biliary drainage) is the primary endpoint of the study. Therefore, blood liver function tests (bilirubin, alkaline phosphatase) as well as the minimum diameter of the common bile duct in the area of the stricture, the maximum diameter of the common bile duct above the stricture and the length of the stricture are measured at ERCPs at the time of the initial plastic stent insertion (i.e. the first ERCP) and at removal of cSEMS or multiple plastic stents (the last ERCP). In addition, blood liver function tests are measured and abdominal ultrasonography performed in the follow-up six months and two years after the stent removal.
Morbidity and mortality are additional endpoints of the study. Therefore, complications (deaths, stent occlusions, dislodgements or migrations, cholangitis, hemobilia, stone formation above the stent), management of complications, admission times, surgical interventions and any additional care needed are monitored and recorded during the follow-up time. Patients are asked to contact the physician at any time if symptoms such as fever, abdominal pain or jaundice occur.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Helsinki, Finlândia, 00290
- Helsinki University Central Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Benign biliary stricture caused by chronic pancreatitis
Exclusion Criteria:
- Malignancy, cirrhosis acute/chronic hepatitis or abnormal hepatic imaging. First attack of acute pancreatitis.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Plastic stent
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Covered SEMS
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Stricture resolution of the common bile duct in the two study groups
Prazo: 2.5 years
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Stricture resolution during stenting and follow-up period, defined by normal liver function tests and abdominal ultrasonography
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2.5 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Stent removability
Prazo: Time from stent removal to 1 month post-stent removal
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Ability to remove stents endoscopically after six months without stent-removal related complications
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Time from stent removal to 1 month post-stent removal
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Occurrence of complications related to stents and procedure
Prazo: 2.5 years
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2.5 years
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Length of endoscopic procedures in the two groups
Prazo: All endoscopic procedures
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All endoscopic procedures
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jorma Halttunen, MD, PhD, Helsinki University Central Hospital
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 98/13/03/03/08
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