- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07658079
The Effect of the Distance of the Percutaneous Endoscopic Gastrostomy (PEG) Feeding Tube to the Pylorus on the Postoperative Outcomes (PEG)
Nutrition is the intake of essential nutrients in sufficient quantities and at the appropriate times to maintain and improve health and enhance quality of life.
Enteral nutrition is superior to parenteral nutrition and should be preferred. To protect the gastrointestinal mucosa and maintain normal flora, patients should begin enteral nutrition as soon as possible. In patients who cannot take food orally, enteral nutrition is provided via a nasogastric/nasojejunal tube or gastrostomy tube.
Gastrostomy is the first choice for patients with a functional gastrointestinal system, poor oral intake, and requiring long-term nutritional support. Feeding tubes can be placed percutaneously or surgically. Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure that does not increase morbidity or mortality, is cheaper, and saves time compared to surgical gastrostomy. It was first applied in 1980 as an alternative to surgical gastrostomy. During the procedure, a line was defined between the navel and the middle of the left lower costal margin. A feeding tube was then inserted at the junction of the middle 2/3 and the outer 1/3 under local anesthesia, and feeding was started the following day. Vudayagiri et al. reported that the placement site is generally 2 cm medial to the costal margin and 2 cm below the xiphoid process.
Different methods for placing a PEG tube into the stomach (pull technique, push technique, and Russell method) have been described in the literature, with the most common being the "pull" technique. The 2005 ESPEN guidelines noted that in the "pull" technique, gastroscopic visualization of the anterior gastric wall is performed, followed by determination of the puncture site at the distal corpus level.
The exact location of the PEG feeding tube, both on the skin and within the gastric lumen, is not fully understood. Its localization on the abdominal skin will be optimally achieved through endoscopic transillumination. However, its level within the gastric lumen is predictable. In our study, we aimed to investigate how measuring the distance of the feeding tube from the pylorus in patients undergoing PEG placement affects post-procedure outcomes and to determine the optimal level within the gastric lumen. Additionally, the placement of the catheter on the skin will be recorded in each patient. Traditionally, tube feeding has been delayed until up to 24 hours after percutaneous endoscopic gastrostomy (PEG) procedure. However, results from various randomized controlled trials suggest that early feeding may be an option. A meta-analysis indicated that early feeding (< or = 4 hours) after PEG placement may be a safe alternative to delayed or next-day feeding. However, although there was no difference in overall complications in this meta-analysis, there was a significant increase in gastric residual volume on day 1 in patients who started early feeding. In another meta-analysis conducted by Szary et al., early tube feeding ≤3 hours after PEG placement; Complications, death within ≤72 hours, or significant gastric residual volume on day 1 were found to be significantly different from delayed or next-day feeding. Our study will be the first of its kind in this field. Therefore, to minimize all factors that could negatively affect the results, we will initiate enteral feeding 24 hours after the traditionally used procedure.
Descripción general del estudio
Estado
Descripción detallada
Nutrition is the intake of essential nutrients in sufficient quantities and at the appropriate times to maintain and improve health and enhance quality of life.
Enteral nutrition is superior to parenteral nutrition and should be preferred. To protect the gastrointestinal mucosa and maintain normal flora, patients should begin enteral nutrition as soon as possible. In patients who cannot take food orally, enteral nutrition is provided via a nasogastric/nasojejunal tube or gastrostomy tube.
Gastrostomy is the first choice for patients with a functional gastrointestinal system, poor oral intake, and requiring long-term nutritional support. Feeding tubes can be placed percutaneously or surgically. Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure that does not increase morbidity or mortality, is cheaper, and saves time compared to surgical gastrostomy. It was first applied in 1980 as an alternative to surgical gastrostomy. During the procedure, a line was defined between the navel and the middle of the left lower costal margin. A feeding tube was then inserted at the junction of the middle 2/3 and the outer 1/3 under local anesthesia, and feeding was started the following day. Vudayagiri et al. reported that the placement site is generally 2 cm medial to the costal margin and 2 cm below the xiphoid process.
Different methods for placing a PEG tube into the stomach (pull technique, push technique, and Russell method) have been described in the literature, with the most common being the "pull" technique. The 2005 ESPEN guidelines noted that in the "pull" technique, gastroscopic visualization of the anterior gastric wall is performed, followed by determination of the puncture site at the distal corpus level.
The exact location of the PEG feeding tube, both on the skin and within the gastric lumen, is not fully understood. Its localization on the abdominal skin will be optimally achieved through endoscopic transillumination. However, its level within the gastric lumen is predictable. In our study, we aimed to investigate how measuring the distance of the feeding tube from the pylorus in patients undergoing PEG placement affects post-procedure outcomes and to determine the optimal level within the gastric lumen. Additionally, the placement of the catheter on the skin will be recorded in each patient. Traditionally, tube feeding has been delayed until up to 24 hours after percutaneous endoscopic gastrostomy (PEG) procedure. However, results from various randomized controlled trials suggest that early feeding may be an option. A meta-analysis indicated that early feeding (< or = 4 hours) after PEG placement may be a safe alternative to delayed or next-day feeding. However, although there was no difference in overall complications in this meta-analysis, there was a significant increase in gastric residual volume on day 1 in patients who started early feeding. In another meta-analysis conducted by Szary et al., early tube feeding ≤3 hours after PEG placement; Complications, death within ≤72 hours, or significant gastric residual volume on day 1 were found to be significantly different from delayed or next-day feeding. Our study will be the first of its kind in this field. Therefore, to minimize all factors that could negatively affect the results, we will initiate enteral feeding 24 hours after the traditionally used procedure.
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Over 18 years of age
- No history of major abdominal surgery (appendectomy, hernia, etc.)
- Patients who started feeding 24 hours after the PEG procedure
- Patients not using prokinetic agents.
Exclusion Criteria:
- History of stomach, small intestine, large intestine surgery or any history of major abdominal surgery
- Having undergone surgical gastrostomy
- Expected gastroparesis (hemodynamic instability, inotropic support, electrolyte imbalance, etc.)
- Intestinal motility disorder
- Patients who started feeding early
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Group-1
The Distance of the Percutaneous Endoscopic Gastrostomy (PEG) Feeding Tube to the Pylorus-The Nearest
|
|
Group-2
The Distance of the Percutaneous Endoscopic Gastrostomy (PEG) Feeding Tube to the Pylorus-The Middle
|
|
Group-3
The Distance of the Percutaneous Endoscopic Gastrostomy (PEG) Feeding Tube to the Pylorus- The Farthest
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The distance to the pylorus
Periodo de tiempo: 01.09.2026-01.09.2027
|
The distance to the pylorus will be measured using a marked catheter advanced through the gastrostomy tube. Additionally, skin mapping will be performed based on the xiphoid, umbilicus, and costal arch. At the end of the study, the distance of the feeding tube from the pylorus and its level on the skin will be obtained for all patients. Complications during the PEG procedure (periprocedural) and early post-procedure (before PEG tract maturation) include bleeding, perforation, pneumoperitoneum, perforation of other organs, PEG tube dislodgement, intraperitoneal leakage, local wound infection-skin ulcers, and necrotizing fasciitis. Wound monitoring and dressing changes will be daily for at least the first 7 days, then every 2-3 days until initial wound healing (first 2 weeks). Both complications and nutritional status/tolerance will be recorded separately. |
01.09.2026-01.09.2027
|
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SisliEtfal-PEG-2026
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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