Comparison of Perioperative Outcomes Between Minimally Invasive and Open Pancreaticoduodenectomy

Comparison of Perioperative Outcomes Between Minimally Invasive and Open Approach for Pancreaticoduodenectomy: a Single-center, Patient-blinded, Randomized Controlled Trial

Patrocinadores

Patrocinador principal: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Fuente Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Resumen breve

The phase 3 randomized trial is to compare perioperative outcomes between minimally invasive and open approach for pancreaticoduodenectomy

Descripción detallada

This is a single-blinded randomized trial aiming to examine the outcomes associated with minimally invasive pancreaticoduodenectomy (MIPD), including robotic or laparoscopic, versus open pancreaticoduodenectomy. Adult patients with symptomatic benign, premalignant, or resectable malignant pathologies recommended for resection after a multidisciplinary review will be evaluated for inclusion into the study.

Patients recruited will be randomized in a 1:1 ratio to either MIPD or open pancreaticoduodenectomy. A specialized abdominal dressing (40x40cm) will be applied to blind the patient from the intervention. The primary outcome(time to functional recovery) and secondary outcomes(including rates of post-surgery complications and sequential quality of life) will be recorded in detail and analyzed.

Estado general Recruiting
Fecha de inicio February 18, 2020
Fecha de Terminación June 2024
Fecha de finalización primaria June 2024
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Time to functional recovery Day 1 post-intervention to functional recovery
Resultado secundario
Medida Periodo de tiempo
Number of participants experiencing complications Day 90 post-intervention
Length of hospital stay up to 90 days post intervention
Number of participants experiencing pancreaticoduodenectomy-specific complications Day 90 post-intervention
Pathological outcomes as assessed by Pathological response to neoadjuvant therapy Day 90-post intervention
Quality of life (QoL) as measured by EQ-5D-3L EQ-5D-3L will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.
Quality of life (QoL) as measured by QLQ-C30 (version 3) QLQ-C30 will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.
Operative estimated blood loss During the surgery
Inscripción 240
Condición
Intervención

Tipo de intervención: Procedure

Nombre de intervención: minimally invasive pancreaticoduodenectomy

Descripción: The minimally invasive pancreaticoduodenectomy is performed through small incisions using robotic-assisted technology or endoscopic techniques. Pancreaticoduodenectomy is the operation that is necessary to remove tumors of the head and neck of the pancreas, lower portion of the bile duct, and the ampulla of Vater.

Etiqueta de grupo de brazo: Cohort A-minimally invasive pancreaticoduodenectomy

Tipo de intervención: Procedure

Nombre de intervención: open pancreaticoduodenectomy

Descripción: Open pancreaticoduodenectomy is considered the current standard of care. Pancreaticoduodenectomy is the operation that is necessary to remove tumors of the head and neck of the pancreas, lower portion of the bile duct, and the ampulla of Vater

Etiqueta de grupo de brazo: Cohort B-open pancreaticoduodenectomy

Elegibilidad

Criterios:

Inclusion Criteria:

- ≥18 years old

- Symptomatic benign, premalignant, or resectable malignant periampullary and pancreatic tumor requiring resection

- Fit to undergo elective pancreaticoduodenectomy after evaluation by the surgical and anesthesiology teams

- Able to consent to participate in the study

- Appropriate for minimally invasive approach as determined by participating surgeons

Exclusion Criteria:

- Arterial (superior mesenteric artery, celiac axis, hepatic artery) or venous involvement (superior mesenteric vein, portal vein) which meets the definition of borderline or unresectable tumor

- Pregnancy

- BMI >40 kg/m2

- Patient requires an additional surgical resection during the index operation (such as hepatectomy or colectomy)

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Jin He, MD,PhD Principal Investigator Johns Hopkins University
Contacto general

Apellido: Jin He, MD,PhD

Teléfono: +1(410)614-7551

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Johns Hopkins Hospital Jin He, MD, PhD [email protected]
Ubicacion Paises

United States

Fecha de verificación

March 2020

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Número de brazos 2
Grupo de brazo

Etiqueta: Cohort A-minimally invasive pancreaticoduodenectomy

Tipo: Experimental

Descripción: Patients randomized to Cohort A will undergo pancreaticoduodenectomy through small incisions with state-of-the-art robotic-assisted technology or endoscopic techniques.

Etiqueta: Cohort B-open pancreaticoduodenectomy

Tipo: Active Comparator

Descripción: Patients randomized to this arm will undergo open pancreaticoduodenectomy.

Datos del paciente No
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Single (Participant)

Fuente: ClinicalTrials.gov