Early Oral Intake After Pancreaticoduodenectomy in the Age of ERAS

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Periampullary Carcinoma Resectable, Pancreaticoduodenectomy

Intervention / Treatment
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* Procedure: early oral intake
* Procedure: jejunostomy tube feeding (JTF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Periampullar carcinoma Pancreaticoduodenectomy ERAS protocol implemented Exclusion Criteria: Preoperative Radiotherapy/chemotherapy Unresectable primary cancer Palliative surgery New York Heart Association class>3

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 early oral intake<br>early oral intake since postoperative day 1. | Procedure: early oral intake<br>* early oral intake is started within 24 hours after pancreaticoduodenectomies following to the ERAS guideline<br>|
| Experimental: 2 jejunostomy tube feeding (JTF)<br>jejunostomy tube feeding (JTF) was carried out after PD | Procedure: jejunostomy tube feeding (JTF)<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance of Oral Intake | the amount of oral intake is recorded, including clear fluids, soft and solid food. | postoperative 1 to 7day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity rate | 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. | postoperative 1day to discharge, up to 8 weeks | 
| length of stay | postoperative length of stay | postoperative 1day to discharge,up to 8 weeks | 
| Readmission rate |  | 30 days after discharge | 
| Hospital costs |  | postoperative 1day to discharge,up to 8 weeks | 
| Albumin | serum albumin | postoperative 30d | 
| weight | weight in kilograms | postoperative 30d | 
| height | height in meters | postoperative 30d |