Pre-ERCP High Carbohydrate Drinks Improve Patients Recovery

• ClinicalTrials.gov Identifier: NCT03075280
• Recruitment Status: Completed
• First Posted: March 9, 2017
• Last Update Posted: August 9, 2022
• Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Information provided by (Responsible Party): Xun Li, Hepatopancreatobiliary Surgery Institute of Gansu Province

Tracking Information

• First Submitted Date: March 4, 2017
• First Posted Date: March 9, 2017
• Last Update Posted Date: August 9, 2022
• Actual Study Start Date: April 1, 2017
• Actual Primary Completion Date: April 17, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 8, 2017)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 8, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pre-ERCP High Carbohydrate Drinks Improve Patients Recovery
• Official Title: Pre-ERCP Carbohydrate Drinks Improve Patients Recovery: an ERAS Protocol Attempts in ERCP
• Brief Summary: To test the benefits of extra high carbohydrate liquid diet uptake 2 hours before ERCP in improving patients' early recovery.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Complication

Intervention

Procedure: 400ml high carbohydrate liquid diet before ERCP

400ml high carbohydrate liquid diet uptake 2 hours before ERCP

Other Name: Routine ERCP

Study Arms

• Experimental: High carbohydrate liquid diet
  No need preoperative fasting more than 6 hours. Uptake 400ml high carbohydrate liquid diet 2 hours before ERCP.
  Intervention: Procedure: 400ml high carbohydrate liquid diet before ERCP
• No Intervention: Routine ERCP group
  Preoperative fasting more than 6 hours as usual.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 7, 2022): 1292
• Original Estimated Enrollment (submitted: March 8, 2017): 1500
• Actual Study Completion Date: April 17, 2021
• Actual Primary Completion Date: April 17, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03075280
• Other Study ID Numbers: HSIGansu
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Xun Li, Hepatopancreatobiliary Surgery Institute of Gansu Province
• Original Responsible Party: Same as current
• Current Study Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Verification Date: August 2022