Early Oral Intake After Pancreaticoduodenectomy in the Age of ERAS

Xuzhou Medical University

Status: Unknown

Conditions: Pancreaticoduodenectomy; Periampullary Carcinoma Resectable

Treatments: Procedure: jejunostomy tube feeding (JTF); Procedure: early oral intake

Study type: Interventional

Funder types: Other

Identifiers

NCT02941484

XuzhouMedSch

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Periampullar carcinoma
• Pancreaticoduodenectomy
• ERAS protocol implemented

Exclusion criteria

• Preoperative Radiotherapy/chemotherapy
• Unresectable primary cancer
• Palliative surgery
• New York Heart Association class>3

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

1 early oral intake

Experimental group

Description:

early oral intake since postoperative day 1.

Treatment:

Procedure: early oral intake

2 jejunostomy tube feeding (JTF)

Experimental group

Description:

jejunostomy tube feeding (JTF) was carried out after PD

Treatment:

Procedure: jejunostomy tube feeding (JTF)