Early Oral Intake After Pancreaticoduodenectomy in the Age of ERAS

Not Applicable

• Conditions: Pancreaticoduodenectomy; Periampullary Carcinoma Resectable
• Interventions: Procedure: early oral intake; Procedure: jejunostomy tube feeding (JTF)

• Registration Number: NCT02941484
• Lead Sponsor: Xuzhou Medical University

Brief 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.

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-16
• Study First Submitted QC: 2016-10-20
• Last Update Submitted: 2016-10-20
• Study First Posted: 2016-10-21
• Last Update Posted: 2016-10-21
• Study Start: 2016-12
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Periampullar carcinoma
• Pancreaticoduodenectomy
• ERAS protocol implemented

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 early oral intake	early oral intake	early oral intake since postoperative day 1.
2 jejunostomy tube feeding (JTF)	jejunostomy tube feeding (JTF)	jejunostomy tube feeding (JTF) was carried out after PD

Primary Outcome Measures

Name	Time	Method
Tolerance of Oral Intake	postoperative 1 to 7day	the amount of oral intake is recorded, including clear fluids, soft and solid food.

Secondary Outcome Measures

Name	Time	Method
morbidity rate	postoperative 1day to discharge, up to 8 weeks	complications associated with surgery, early oral intake,and jejunostomy tube.Definitions used for specific complications are according to the International Study Group on Pancreatic Fistula (ISGPF) definition.
length of stay	postoperative 1day to discharge,up to 8 weeks	postoperative length of stay
Readmission rate	30 days after discharge
Hospital costs	postoperative 1day to discharge,up to 8 weeks
Albumin	postoperative 30d	serum albumin
weight	postoperative 30d	weight in kilograms
height	postoperative 30d	height in meters

Trial Locations

Locations (1)

Suqian Hospital; 🇨🇳 Suqian, Jiangsu, China