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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07927101
Effects of a Preoperative Capsaicin-Containing Diet on Postoperative Liver Injury Repair: A Randomized Controlled Trial
The goal of this clinical trial is to learn whether a capsaicin-containing diet started before surgery can reduce liver injury and help the liver recover in adults aged 18 to 75 years who are scheduled for surgery to remove part of the liver because of a liver mass. Capsaicin is the substance that makes chili peppers spicy. The study will also assess the safety and tolerability of this diet.
The main questions it aims to answer are:
Does the capsaicin-containing diet help blood levels of alanine aminotransferase (ALT), a marker of liver injury, fall more quickly between the first and fifth days after surgery?
Does it improve other measures of liver recovery and reduce liver failure after surgery?
What side effects, including stomach or intestinal discomfort, occur during the study?
Researchers will compare a jelly containing chili powder with a similar-looking placebo jelly containing sweet pepper powder without capsaicin. Both groups will receive the same standard care before, during, and after surgery.
The study plans to enroll 110 participants. Participants will be assigned by chance to one of the two groups, with an equal chance of receiving either study diet. Participants and the researchers assessing their recovery will not know which diet they receive.
Participants will:
Take the assigned jelly three times daily with meals, starting 2 days before surgery and continuing through the evening of the first day after surgery, with a pause for surgery as directed by the study team. The capsaicin group will receive approximately 7.5 mg of capsaicin per day.
Avoid other spicy foods while taking the study diet.
Have blood tests before and after surgery to assess liver injury, liver function, and safety.
Report any discomfort or other health problems to the study team.
Complete follow-up assessments around 30 and 90 days after surgery to check recovery, complications, hospital readmissions, and survival.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Xinyu Zhan
- Número de teléfono: 18163017789
- Correo electrónico: zhanxinyu990618@163.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 18 to 75 years, of any sex.
A focal liver lesion scheduled for elective open or laparoscopic liver resection, such as hepatocellular carcinoma, colorectal liver metastases, or hepatic hemangioma.
Child-Pugh class A or B with a score of 7 or less, and indocyanine green retention at 15 minutes (ICG-R15) of 20% or less.
Planned intraoperative hepatic inflow occlusion.
An anticipated future liver remnant of at least 30% in patients with a normal liver or at least 40% in patients with cirrhosis.
Ability to tolerate an oral chili powder challenge, such as 0.5 g without gastrointestinal discomfort.
Willingness and ability to comply with the standardized study diet initiated 2 days before surgery, with a planned capsaicin dose of 7.5 mg/day in three divided doses with meals for participants assigned to the capsaicin group, and provision of written informed consent.
No severe cardiac, pulmonary, or renal dysfunction, with an estimated glomerular filtration rate (eGFR) of at least 60 mL/min.
No history of liver transplantation or other organ transplantation.
Exclusion Criteria:
- Pregnancy or breastfeeding.
A history of or current malignancy other than the disease for which liver resection is planned, unless cured for at least 5 years without recurrence. Hepatocellular carcinoma scheduled for resection, and colorectal liver metastases together with their corresponding colorectal primary cancer, are not excluded under this criterion.
Persistent preoperative elevation of transaminases or total bilirubin above twice the upper limit of normal that does not improve with treatment, or a white blood cell count below the lower limit of normal.
A requirement for a combined radical oncologic procedure, such as pancreaticoduodenectomy or radical resection for hilar cholangiocarcinoma.
Tumor thrombus in the main portal vein, the right or left portal vein branch, a hepatic vein, or the inferior vena cava.
Severe cirrhosis with a Child-Pugh score of 8 or higher, or moderate to severe esophagogastric varices identified by endoscopy.
Active bleeding, a coagulation disorder with an international normalized ratio (INR) greater than 1.5 or a platelet count below 100 × 10^9/L, or another contraindication to surgery.
Severe cardiac, pulmonary, or renal dysfunction, defined as New York Heart Association (NYHA) functional class III or IV, forced expiratory volume in 1 second (FEV1) below 50% of the predicted value, or eGFR below 60 mL/min.
A history of or current active peptic ulcer disease, severe gastritis, gastroesophageal reflux disease (GERD), or a known allergy to chili powder or capsaicin.
Severe infection, active tuberculosis, autoimmune hepatitis, or another acute or chronic systemic disease.
Participation in another interventional clinical trial or use of an investigational drug affecting liver function within the preceding 3 months.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Capsaicin-Containing Diet
|
A food-based dietary intervention consisting of an oral jelly containing Thai chili powder. Each 15-mL serving contains 1.25 g of chili powder, providing approximately 2.5 mg of capsaicin. One serving is taken orally three times daily with meals, for a total of 3.75 g of chili powder and approximately 7.5 mg of capsaicin per day. Administration begins 2 days before surgery and continues through the evening of postoperative day 1, with perioperative interruption for surgery. Participants avoid other spicy foods during the intervention period. |
|
Comparador de placebos: Placebo Diet
|
An oral placebo jelly containing sweet pepper powder without capsaicin, matched to the capsaicin-containing jelly in appearance and caloric content. One serving is taken orally three times daily with meals, beginning 2 days before surgery and continuing through the evening of postoperative day 1, with perioperative interruption for surgery. Participants avoid other spicy foods during the intervention period. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative Alanine Aminotransferase (ALT) Recovery Rate
Periodo de tiempo: From 24 to 120 hours after liver resection (postoperative days 1 to 5).
|
The postoperative ALT recovery rate is assessed using the decline in the natural logarithm of serum ALT between 24 and 120 hours after liver resection, expressed as a rate per 24 hours. Serum ALT is measured preoperatively and at 24 and 120 hours postoperatively. The preoperative measurement serves as the baseline reference. |
From 24 to 120 hours after liver resection (postoperative days 1 to 5).
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Palabras clave
Otros números de identificación del estudio
- TJ-202512181
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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