- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07681128
The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy
The Effect of Braun Anastomosis on Delayed Gastric Emptying (DGE) in Reconstruction After Pancreaticoduodenectomy: A Prospective Single-center Randomized Controlled Trial
Pancreaticoduodenectomy (PD) is the only curative procedure for periampullary malignant tumors. Although modern perioperative management has greatly reduced postoperative mortality, delayed gastric emptying (DGE) remains one of the most common and troublesome complications after PD, with an incidence up to 30%. DGE leads to abdominal distension, nausea, vomiting, intolerance of oral diet, prolonged hospital stay, increased medical costs, delayed adjuvant therapy initiation, and impaired long-term nutritional recovery and quality of life.
Braun anastomosis (BE) can reconstruct the gastrointestinal tract by side-to-side jejunojejunostomy between the afferent and efferent limbs, which may reduce intestinal stasis, bile reflux and afferent limb obstruction, and theoretically lower the risk of postoperative DGE. However, current clinical studies and meta-analyses remain controversial regarding the actual efficacy of BE in preventing DGE after PD. Some studies support that BE can reduce DGE incidence, shorten hospitalization and improve postoperative recovery, while others demonstrate no statistically significant benefit, or even concern about prolonged operative time and technical difficulty. Existing evidence is limited by small sample size, retrospective design and potential selection bias, and high-quality prospective randomized controlled trials are still lacking to confirm the clinical value of BE.
This study is designed as a prospective, single-center, randomized controlled trial, aiming to evaluate the impact of routine Braun anastomosis during digestive tract reconstruction on the incidence and severity of postoperative DGE in patients undergoing pancreaticoduodenectomy for malignant tumors. The results will provide high-level clinical evidence for the rational application of Braun anastomosis in PD reconstruction and guide standardized clinical practice.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yunlong Cui, PhD
- Número de teléfono: +86 18622228633
- Correo electrónico: ningyunlong@163.com
Ubicaciones de estudio
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Porcelana, 300060
- Reclutamiento
- Tianjin Medical University Cancer Institute & Hospital
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Contacto:
- Yunlong Cui
- Número de teléfono: +86 18622228633
- Correo electrónico: ningyunlong@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ≥ 18 years, male or female;
- Scheduled to undergo curative pancreaticoduodenectomy (PD);
- Undergoing PD for malignant or borderline tumors, with planned antecolic Billroth II reconstruction;
- Mentally competent and able to provide written informed consent.
Exclusion Criteria:
- Age < 18 years;
- Prior diagnosis of gastroparesis;
- Benign disease as the indication for PD;
- Previous history of upper gastrointestinal surgery;
- Preoperative pyloric obstruction;
- Planned pylorus-preserving pancreaticoduodenectomy (PPPD);
- Patients who have received neoadjuvant or conversion therapy;
- Preoperative glycated hemoglobin (HbA1c) > 7.5%;
- Preoperative total bilirubin level > 200 μmol/L;
- Unable or unwilling to provide written informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Braun arm
PD with Billroth II reconstruction plus Braun anastomosis
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Intervention Group: Patients undergo PD with antecolic Billroth II reconstruction plus Braun enteroenterostomy (BE).
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Otro: Non Braun Arm
PD with Billroth II reconstruction alone (without Braun anastomosis)
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Patients undergo PD with standard antecolic Billroth II reconstruction without Braun enteroenterostomy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of delayed gastric emptying (DGE)
Periodo de tiempo: Postoperative days 1, 8, 15, and 22
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Incidence of delayed gastric emptying (DGE), defined according to the International Study Group of Pancreatic Surgery (ISGPS) criteria
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Postoperative days 1, 8, 15, and 22
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Length of hospital stay (days)
Periodo de tiempo: From first postoperative day to hospital discharge up to 15 weeks
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Comparison of hospital stay duration between the intervention group and the control group.
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From first postoperative day to hospital discharge up to 15 weeks
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Treatment cost
Periodo de tiempo: From the first postoperative day to one year follow-up
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Evaluation of the difference in medical expenditure between the intervention group and the control group.
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From the first postoperative day to one year follow-up
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Postoperative recovery
Periodo de tiempo: From the first postoperative day to one year follow-up
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Including time to first flatus, time to oral intake, and other related indicators.
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From the first postoperative day to one year follow-up
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Bile reflux
Periodo de tiempo: Assessment of bile reflux by 24-hour intragastric bilirubin monitoring.
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Assessment of bile reflux by 24-hour intragastric bilirubin monitoring.
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Proportion of severe complications as defined by the Clavien-Dindo classification
Periodo de tiempo: From the first postoperative day to one year follow-up
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From the first postoperative day to one year follow-up
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Quality of life scores assessed using the European Organization for Research and Treatment of Cancer (EORTC) questionnaire at 30 days postoperatively
Periodo de tiempo: 30 days
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30 days
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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Braun-HCC
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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