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Completed

NCT Number: NCT03075280

Pre-ERCP High Carbohydrate Drinks Improve Patients Recovery

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Third Military Medical University, Chongqing, Chongqing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

400ml high carbohydrate liquid diet before ERCP

Procedure

400ml high carbohydrate liquid diet uptake 2 hours before ERCP

Other names: Routine ERCP

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hepatopancreatobiliary Surgery Institute of Gansu Province

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 9, 2017
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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