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El ensayo clínico NCT07495111 para Cholelithiasis Associated With Common Bile Duct Stones está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis 88 Aleatorizado

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07495111 es un estudio intervencionista para Cholelithiasis Associated With Common Bile Duct Stones. Su estado actual es: reclutando. El estudio se inició el 1 de diciembre de 2025, con el objetivo de reclutar a 88 participantes. Dirigido por Qilu Hospital of Shandong University, se espera que finalice el 1 de junio de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 27 de marzo de 2026.
Resumen
In this multicenter, randomized trial, patients with cholelithiasis with concomitant choledocholithiasis based on inclusion and exclusion criteria will be randomly assigned to receive rectal indomethacin alone or the combination of indomethacin plus a prophylactic pancreatic stent after endoscopic transpapillary gallbladder-preserving cholecystolithotomy.Clinical data and patient-reported outcomes are regularly colle...Mostrar más
Título oficial

Prophylactic Pancreatic Stent Placement to Prevent Pancreatitis After Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy for Cholelithiasis With Concomitant Choledocholithiasis

Condiciones médicas
Cholelithiasis Associated With Common Bile Duct Stones
Otros ID del estudio
  • 2025SDU-QILU-2
Número del NCT
NCT07495111
Inicio del estudio (real)
2025-12-01
Última actualización
2026-03-27
Fecha de finalización (estimada)
2028-06
Inscripción (prevista)
88
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Palabras clave
Cholelithiasis with Concomitant Choledocholithiasis
Endoscopic Transpapillary Gallbladder-preserving Cholecystolithotomy
post-ERCP pancreatitis
Randomized Controlled Trial (RCT)
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Doble ciego
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
OtrosReceive rectal indomethacin alone
rectal indomethacin alone
rectal indomethacin was used alone in the control group
ExperimentalCombination of indomethacin plus a prophylactic pancreatic stent
Prophylactic pancreatic stent
All procedure-related interventions except for the administration of rectal indomethacin and placement of a prophylactic stent were left to the discretion of the endoscopist.During ERCP, once eligibility was confirmed, patients were randomized in a 1:1 ratio to receive a prophylactic stent or not.In patients assigned to the indomethacin plus stent group, endoscopists were expected to attempt stent placement, although...Mostrar más
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
The Proportion of Patients with Post-ERCP Pancreatitis
If a patient exhibits two out of the following three characteristics, a diagnosis of postoperative pancreatitis is made: (1) Abdominal pain consistent with acute pancreatitis, (2) Serum amylase and/or lipase levels at least three times the upper limit of normal, and (3) Abdominal imaging studies showing radiological changes consistent with acute pancreatitis.
24 hours to 72 hours after ERCP
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
The Proportion of Patients with Mild, Moderate or Severe Post-ERCP Pancreatitis
The severity was defined as mild post-ERCP pancreatitis resulting in a hospitalization of ≤3 days, moderate post-ERCP pancreatitis resulting in a hospitalization of 4-10 days, and severe post-ERCP pancreatitis resulting in a hospitalization of \> 10 days, or leading to the development of pancreatic necrosis or pseudocyst, or requiring percutaneous or surgical intervention.
Within 1 months after ERCP
Clinical Success Rate
Complete removal of gallbladder stones.
Within 1 months after ERCP
The Proportion of Patients with Other Complications
Other complications mainly include bleeding, cholangitis, cholecystitis, perforation, hypoxemia, hypotension or hypertension, etc.
Within 6 months after ERCP
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
  1. Patients aged 18 years or older;
  2. Patients with gallbladder stones and common bile duct (CBD) stones confirmed by ultrasound and/or MRCP or other imaging modalities (CT/MRI);
  3. Patients with every gallbladder stone ≤1 cm in diameter or sludge-like stones;
  4. Patients without a history of gastrointestinal reconstruction surgery,cholecystectomy or previous biliary surgery, includes ERCP;
  5. The morphology and size of the gallbladder are essentially normal and the thickness of the gallbladder wall is ≤3 mm;
  6. Patients with at least one of the following high-risk factors for post-ERCP pancreatitis (PEP): suspected sphincter of Oddi dysfunction (SOD), female sex, history of pancreatitis, difficult cannulation (defined as ≥5 cannulation attempts or ≥5 minutes of cannulation time), pancreatic duct contrast injection, age <35 years, non-dilated extrahepatic bile duct, no history of chronic pancreatitis, normal serum bilirubin, precut sphincterotomy, biliary balloon dilation, incomplete bile duct stone clearance, or intraductal ultrasound ;
  7. Patients who voluntarily provide signed informed consent.

  1. Patients with any of the following diagnoses: chronic atrophic cholecystitis, porcelain gallbladder, suspected gallbladder malignancy, or Mirizzi syndrome;
  2. Patients with ectopic duodenal papilla or congenital pancreaticobiliary malformations;
  3. Patients unfit for ERCP endoscopic treatment due to severe systemic diseases;
  4. Patients with severe coagulation dysfunction (defined as an International Normalized Ratio \[INR\] >1.5) or significant thrombocytopenia (platelet count <50×10⁹/L);
  5. Pregnant women;
  6. Patients with guidewire entry into the pancreatic duct ≥3 times during the procedure;
  7. Patients with allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs);
  8. Patients with congenital or acquired absence of the rectum;
  9. Patients with severe acute pancreatitis
Qilu Hospital of Shandong University logoQilu Hospital of Shandong University
Contactos centrales del estudio
Contacto: Zhen Li, MD, 18560086106, [email protected]
1 Centros del estudio en 1 países

Shandong

Qilu Hospital of Shandong University, Jinan, Shandong, 250063, China
Reclutando