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Pre-ERCP High Carbohydrate Drinks Improve Patients Recovery

Sponsor
Hepatopancreatobiliary Surgery Institute of Gansu Province (Other)
Overall Status
Completed
CT.gov ID
NCT03075280
Collaborator
(none)
1,292
Enrollment
15
Locations
2
Arms
48.5
Actual Duration (Months)
86.1
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: 400ml high carbohydrate liquid diet before ERCP
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
1292 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pre-ERCP Carbohydrate Drinks Improve Patients Recovery: an ERAS Protocol Attempts in ERCP
Actual Study Start Date :
Apr 1, 2017
Actual Primary Completion Date :
Apr 17, 2021
Actual Study Completion Date :
Apr 17, 2021

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Levels of fatigue (Fatigue Scale-14 scoring system) [6 months]

      The patients always feel tired and faint. The clinical manifestation includes slow to respond, the flexibility and coordination disorders.

    2. Abdominal pain [6 months]

      Pain score (scores:1-10)

    Secondary Outcome Measures

    1. The average incubation time [6 months]

      The time of total procedure

    2. Successful cannulation time [6 months]

      From first achieve the papilla to success cannulation

    3. Postoperative abdominal distention [6 months]

      Distention uncomfortable

    4. Postoperative nausea and vomiting [6 months]

      Nausea or vomiting after procedure

    5. Complications [6 months]

      Pancreatitis, cholangitis, bleeding, aspiration, et,al.

    6. Blood glucose [6 months]

      Intra-operative blood glucose and 2 hours' blood glucose after procedure

    7. Intraoperative residues in stomach [6 months]

      The volume of stomach residues

    8. The time eating [6 months]

      The time of eager to eat after procedure

    9. Length of hospital stay [6 months]

      Days of hospital stay

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ERCP patients,

    • Age 18-85 years old.

    Exclusion Criteria:
    • Coagulation dysfunction (INR> 1.3) and low peripheral blood platelet count(<50×109 /
    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Third Military Medical University Chongqing Chongqing China 400038
    2 The first hospital of Lanzhou university Lanzhou Gansu China 730000
    3 The Second Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong China 510260
    4 The Second Hospital of Hebei Medical University Shijiazhuang Hebei China 050000
    5 Tongji medical collage,Huazhong University of science and technology Wuhan Hubei China 430022
    6 Second Xiangya Hospital, Central South University Changsha Hunan China 410011
    7 The First Hospital of Jilin University Changchun Jilin China 130021
    8 General Hospital of Ningxia Medical University Yingchuan Ningxia China 750004
    9 The first affiliated hospital of Xi 'an jiaotong university Xi'an Shaanxi China 710061
    10 Shandong jiaotong Hospital Jinan Shandong China 250000
    11 Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200092
    12 Taiyuan Iron and Steel Corporation Hospital Taiyuan Shanxi China 030008
    13 Tianjin Nankai Hospital Tianjin Tianjin China 300100
    14 The First Teaching Hospital of Xinjiang Medical University Ürümqi Xinjiang China 830054
    15 Shulan Hospital of Zhejiang University Hangzhou Zhejiang China 310003

    Sponsors and Collaborators

    • Hepatopancreatobiliary Surgery Institute of Gansu Province

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xun Li, M.D., Ph. D, Direct of surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province
    ClinicalTrials.gov Identifier:
    NCT03075280
    Other Study ID Numbers:
    • HSIGansu
    First Posted:
    Mar 9, 2017
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xun Li, M.D., Ph. D, Direct of surgery, Hepatopancreatobiliary Surgery Institute of Gansu Province
    ERCP
    ERAS
    complication
    fatigue
    high carbohydrate diet

    Study Results

    No Results Posted as of Aug 9, 2022