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Pre-ERCP High Carbohydrate Drinks Improve Patients Recovery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03075280
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
Xun Li, Hepatopancreatobiliary Surgery Institute of Gansu Province

Study Description
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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
Complication Procedure: 400ml high carbohydrate liquid diet before ERCP Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : April 1, 2017
Actual Primary Completion Date : April 17, 2021
Actual Study Completion Date : April 17, 2021
Arms and Interventions
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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 Name: Routine ERCP
No Intervention: Routine ERCP group
Preoperative fasting more than 6 hours as usual.


Outcome Measures
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Primary Outcome Measures :
  1. Levels of fatigue (Fatigue Scale-14 scoring system) [ Time Frame: 6 months ]
    The patients always feel tired and faint. The clinical manifestation includes slow to respond, the flexibility and coordination disorders.

  2. Abdominal pain [ Time Frame: 6 months ]
    Pain score (scores:1-10)


Secondary Outcome Measures :
  1. The average incubation time [ Time Frame: 6 months ]
    The time of total procedure

  2. Successful cannulation time [ Time Frame: 6 months ]
    From first achieve the papilla to success cannulation

  3. Postoperative abdominal distention [ Time Frame: 6 months ]
    Distention uncomfortable

  4. Postoperative nausea and vomiting [ Time Frame: 6 months ]
    Nausea or vomiting after procedure

  5. Complications [ Time Frame: 6 months ]
    Pancreatitis, cholangitis, bleeding, aspiration, et,al.

  6. Blood glucose [ Time Frame: 6 months ]
    Intra-operative blood glucose and 2 hours' blood glucose after procedure

  7. Intraoperative residues in stomach [ Time Frame: 6 months ]
    The volume of stomach residues

  8. The time eating [ Time Frame: 6 months ]
    The time of eager to eat after procedure

  9. Length of hospital stay [ Time Frame: 6 months ]
    Days of hospital stay


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075280


Locations
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China, Chongqing
Third Military Medical University
Chongqing, Chongqing, China, 400038
China, Gansu
The first hospital of Lanzhou university
Lanzhou, Gansu, China, 730000
China, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260
China, Hebei
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
China, Hubei
Tongji medical collage,Huazhong University of science and technology
Wuhan, Hubei, China, 430022
China, Hunan
Second Xiangya Hospital, Central South University
Changsha, Hunan, China, 410011
China, Jilin
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
China, Ningxia
General Hospital of Ningxia Medical University
Yingchuan, Ningxia, China, 750004
China, Shaanxi
The first affiliated hospital of Xi 'an jiaotong university
Xi'an, Shaanxi, China, 710061
China, Shandong
Shandong jiaotong Hospital
Jinan, Shandong, China, 250000
China, Shanghai
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200092
China, Shanxi
Taiyuan Iron and Steel Corporation Hospital
Taiyuan, Shanxi, China, 030008
China, Tianjin
Tianjin Nankai Hospital
Tianjin, Tianjin, China, 300100
China, Xinjiang
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830054
China, Zhejiang
Shulan Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310003
Sponsors and Collaborators
Hepatopancreatobiliary Surgery Institute of Gansu Province
Investigators
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Principal Investigator: Xun Li, M.D., Ph. D. Hepatopancreatobiliary Surgery Institute of Gansu Province
More Information
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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: March 9, 2017    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xun Li, Hepatopancreatobiliary Surgery Institute of Gansu Province:
ERCP
ERAS
complication
fatigue
high carbohydrate diet