Composite Index for Outcome Burden in Acute Cholangitis
Acute Cholangitis · Biliary Drainage
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - 80 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 514 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The goal of this retrospective observational study is to construct a composite outcome to measure the success of treatment in patients who are presenting with acute cholangitis (blockage and infection of bile ducts) and undergoing a drainage procedure with different modalities. The study is not intended to test any predetermined hypothesis and does not have any comparison group. The participants' data are collated from retrospective hospital records and analysed for the purpose of the study. All the procedures are in place to ensure the confidentiality of the study participants while collating, analysing and sharing study findings.
Leer la descripción completa
Study Aim To develop and internally validate a Composite Index that summarizes overall outcome burden in patients with acute cholangitis.
Primary Objective (Index Development)
1\. To derive a Multidimensional Composite Index for Outcome Burden among patients with acute Cholangitis undergoing Biliary Drainage, that inegrates
- Mortality (30-day and in-hospital)
- Organ support,
- ICU admission and ICU length of stay,
- Complication burden and severity (AGREE and Clavien-Dindo classification as applicable),
- Hospital length of stay,
- 30-day reintervention
- 30-day readmission.
Secondary Objectives
1. To evaluate the association of the Composite Index with:
* TG18 severity grade (I vs II vs III),
* Baseline physiological/lab derangement (WBC, bilirubin, creatinine, lactate),
2. To explore whether timing of biliary drainage is associated with composite index scores (exploratory-hypothesis-generating).
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria
- Age 18 to 80 years
- Hospital admission with definite diagnosis of acute cholangitis meeting TG18 diagnostic criteria
- TG18 Grade I (Mild) Grade II (moderate) or Grade III (severe) at presentation/admission or prior to drainage.
- Underwent biliary drainage attempt (ERCP/PTBD/EUS-BD) or were planned for drainage (including failures with rescue drainage).
- First episode of index BD in case of patients undergoing multiple episodes of index BD as per operational definitions (Technical supplement 1)
- Planned repeat BD in same admission shall be considered as continuation of the index BD and all the procedural details shall be documented and analysed.
Exclusion Criteria
- Pregnant women
- Missing key outcome data (minimum required: mortality status + ICU admission status + Length of stay)
- Non-biliary sepsis without evidence of biliary obstruction/infection on review.
- A patients with past history of BD outside the study setting (As this is akin to second episode of Index BD)
- Subsequent episodes of Index BD (other than the first index BD episode) among patients with more than one episode of Index BD.
Población del estudio
Study Population
- Age 18 to 80 years
- Hospital admission with definite diagnosis of acute cholangitis meeting TG18 diagnostic criteria
- TG18 Grade I (Mild), Grade II (moderate) or Grade III (severe) at presentation/admission or prior to drainage.
- Underwent biliary drainage attempt (ERCP/PTBD/EUS-BD) or were planned for drainage (including failures with rescue drainage).
- First episode of index BD in case of patients undergoing multiple episodes of index BD as per operational definitions (Technical supplement 1).
- Planned repeat BD in same admission shall be considered as continuation of the index BD and all the procedural details shall be documented and analysed.
Tratamiento, grupos y participación
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- Asignación
- No informado
- Enmascaramiento
- No informado
Patients with acute cholangitis meeting TG18 diagnostic criteria underwent biliary drainage attempt
No informado en este registro.
Procedure: Biliary drainage
Biliary drainage PROCEDURE
Underwent biliary drainage attempt (ERCP/PTBD/EUS-BD) or were planned for drainage (including failures with rescue drainage)
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Multidimensional Composite Index for Outcome Burden among patients with acute Cholangitis undergoing Biliary Drainage
Plazo: 30 days
To derive a Multidimensional Composite Index for Outcome Burden among patients with acute Cholangitis undergoing Biliary Drainage, that integrates mortality (30-day and in-hospital), organ support, ICU admission and ICU length of stay, complication burden and severity (AGREE and Clavien-Dindo classification as applicable), hospital length of stay, 30-day reintervention and 30-day readmission.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Asian Institute of Gastroenterology Pvt Ltd (AIG Hospitals)Hyderabad, Telangana, IndiaReclutando
Equipo y fechas
- Patrocinador principal
- Asian Institute of Gastroenterology, India
- Inicio del estudio
- 20 abr 2026 Real
- Finalización primaria
- 31 dic 2026 Estimado
- Finalización del estudio
- 31 dic 2026 Estimado
- Primera publicación
- 24 jun 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Development and Internal Validation of a Multidimensional Composite Index for Outcome Burden in Acute Cholangitis: A Multicentre Retrospective Cohort Study in India
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026