Pre-ERCP High Carbohydrate Drinks Improve Patients Recovery

Study Overview
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Brief Summary
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To test the benefits of extra high carbohydrate liquid diet uptake 2 hours before ERCP in improving patients' early recovery.

Detailed Description
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Enhanced recovery after surgery (ERAS) has been formed of procedure which contains preoperative education, improvement of anesthesia, reducing the number of drainage tubes, and early diet after surgery. In recent years, because of its positive advantages, ERAS was widely accepted in surgical fields. For upper gastrointestinal surgery, high-carbohydrate drinks can be given 2 hours before surgery in order to guarantee the stability of blood glucose and circulation during the operation. It obviously reduce the preoperative thirst, hunger, irritability and even the incidence of postoperative complications. However ERAS program is rarely studied in ERCP. Theoretically we can use ERAS as a strategy to reduce post-ERCP uncomfortable and complications.

Official Title
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Pre-ERCP Carbohydrate Drinks Improve Patients Recovery: an ERAS Protocol Attempts in ERCP

Conditions
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Complication

Intervention / Treatment
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* Procedure: 400ml high carbohydrate liquid diet before ERCP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ERCP patients, Age 18-85 years old. Exclusion Criteria: Coagulation dysfunction (INR> 1.3) and low peripheral blood platelet count(<50×109 / L) or using anti-coagulation drugs, Preoperative coexistent diseases: acute pancreatitis, GI tract hemorrhage, severe liver disease, shock, liver or kidney malfunction, Diabetes（blood glucose fluctuations）or with complications, Intestinal obstruction or other contraindications with feeding and watering, Prior surgery of Bismuth Ⅱ and Roux-en-Y, Pregnant women, Unwillingness or inability to consent for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: High carbohydrate liquid diet<br>No need preoperative fasting more than 6 hours. Uptake 400ml high carbohydrate liquid diet 2 hours before ERCP. | Procedure: 400ml high carbohydrate liquid diet before ERCP<br>* 400ml high carbohydrate liquid diet uptake 2 hours before ERCP<br>* Other names: Routine ERCP;|
| No Intervention: Routine ERCP group<br>Preoperative fasting more than 6 hours as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of fatigue (Fatigue Scale-14 scoring system) | The patients always feel tired and faint. The clinical manifestation includes slow to respond, the flexibility and coordination disorders. | 6 months | 
| Abdominal pain | Pain score (scores:1-10) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average incubation time | The time of total procedure | 6 months | 
| Successful cannulation time | From first achieve the papilla to success cannulation | 6 months | 
| Postoperative abdominal distention | Distention uncomfortable | 6 months | 
| Postoperative nausea and vomiting | Nausea or vomiting after procedure | 6 months | 
| Complications | Pancreatitis, cholangitis, bleeding, aspiration, et,al. | 6 months | 
| Blood glucose | Intra-operative blood glucose and 2 hours' blood glucose after procedure | 6 months | 
| Intraoperative residues in stomach | The volume of stomach residues | 6 months | 
| The time eating | The time of eager to eat after procedure | 6 months | 
| Length of hospital stay | Days of hospital stay | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, ERAS, complication, fatigue, high carbohydrate diet