Pre-ERCP High Carbohydrate Drinks Improve Patients Recovery

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

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

Study Overview

• Status: Completed
• Conditions: Complication
• Intervention / Treatment: Procedure: 400ml high carbohydrate liquid diet before ERCP

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1292
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Third Military Medical University
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • The First Hospital of Lanzhou University
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • The Second Affiliated Hospital of Guangzhou Medical University
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Tongji medical collage,Huazhong University of science and technology
  • Hunan
    • Changsha, Hunan, China, 410011
      • Second Xiangya Hospital, Central South University
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Ningxia
    • Yingchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi 'An Jiaotong University
  • Shandong
    • Jinan, Shandong, China, 250000
      • Shandong jiaotong Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  • Shanxi
    • Taiyuan, Shanxi, China, 030008
      • Taiyuan Iron and Steel Corporation Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300100
      • Tianjin Nankai Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830054
      • The First Teaching Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Shulan Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High carbohydrate liquid diet; 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; 400ml high carbohydrate liquid diet uptake 2 hours before ERCP; Other Names: Routine ERCP
No Intervention: Routine ERCP group; Preoperative fasting more than 6 hours as usual.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Investigators: Principal Investigator: Xun Li, M.D., Ph. D., Hepatopancreatobiliary Surgery Institute of Gansu Province

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): April 17, 2021
• Study Completion (Actual): April 17, 2021

Study Registration Dates

• First Submitted: March 4, 2017
• First Submitted That Met QC Criteria: March 8, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 7, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: fatigue; ERCP; ERAS; complication; high carbohydrate diet
• Other Study ID Numbers: HSIGansu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No