NCT02941484

Early Oral Intake After Pancreaticoduodenectomy in the Age of ERAS

A Prospective, Randomized Trial of Early Oral Intake After Pancreaticoduodenectomy in the Age of ERAS

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Early oral intake after Pancreaticoduodenectomy is recommended strongly according to the ERAS guideline, which was based on studies in patients with gastrointestinal cancer, mainly colorectal and gastric. Specific clinical study on early oral intake after PD is very limited. inadequate nutritional intake was significantly associated with a high incidence of postoperative complications. Therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing PD in the age of ERAS.

Detailed description

Enhanced Recovery After Surgery (ERAS) is an interdisciplinary, multimodal concept and has become an important focus of Pancreaticoduodenectomy procedures following universal accepted and practice in gastrointestinal and colorectal surgeries. Early oral diet without restrictions after operation is recommended strongly according to ERAS guideline. However, several studies demonstrated that only half validated the true practice of the postoperative oral diet. Furthermore, Oral intake tolerance after PD is controversial. Only 23% of patients were able to take solid food at day 3. It appears that adequate nutritional intake only via oral diet is a severe challenge. Besides, Studies showed that insufficient amount of dietary intake was significantly associated with extended duration of postoperative hospitalization and parenteral nutrition. Importantly, Specific clinical study on early oral intake after PD is very limited. Therefore, the present study is aim to evaluate the tolerance, safety, and efficacy in the patients undergoing PD in the age of ERAS.

Conditions

• Periampullary Carcinoma Resectable
• Pancreaticoduodenectomy

Interventions

Type	Name	Description
PROCEDURE	early oral intake	early oral intake is started within 24 hours after pancreaticoduodenectomies following to the ERAS guideline
PROCEDURE	jejunostomy tube feeding (JTF)	The jejunostomy tube was placed using the Flocare CH-10 tube with the longitudinal Witzel jejunostomy technique.nutrition is supplemented via JTF rather than early oral intake.Velocity is progressively increased by 20ml/hr until full nutritional goal (25Kcal/Kg)

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-10-21
• Last updated: 2016-10-21

Locations

1 site across 1 country: China