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The Effect of the Distance of the Percutaneous Endoscopic Gastrostomy (PEG) Feeding Tube to the Pylorus on the Postoperative Outcomes (PEG)

14 de junio de 2026 actualizado por: Sinan Ömeroğlu, MD, Sisli Hamidiye Etfal Training and Research Hospital

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

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

De observación

Inscripción (Estimado)

200

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra de probabilidad

Población de estudio

Demographic, clinical, and postoperative data of patients who will undergo PEG procedures in our hospital's surgical endoscopy unit between September 1, 2026, and September 1, 2027, as indicated by neurology, gastroenterology, and intensive care physicians, will be examined.

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

31 de agosto de 2027

Finalización del estudio (Estimado)

31 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

14 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de junio de 2026

Publicado por primera vez (Actual)

18 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

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.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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