Pre-ERCP High Carbohydrate Drinks Improve Patients Recovery
Pre-ERCP Carbohydrate Drinks Improve Patients Recovery: an ERAS Protocol Attempts in ERCP
1 other identifier
interventional
1,292
1 country
15
Brief Summary
To test the benefits of extra high carbohydrate liquid diet uptake 2 hours before ERCP in improving patients' early recovery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2017
CompletedFirst Posted
Study publicly available on registry
March 9, 2017
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2021
CompletedAugust 9, 2022
August 1, 2022
4 years
March 4, 2017
August 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (9)
The average incubation time
6 months
Successful cannulation time
6 months
Postoperative abdominal distention
6 months
Postoperative nausea and vomiting
6 months
Complications
6 months
- +4 more secondary outcomes
Study Arms (2)
High carbohydrate liquid diet
EXPERIMENTALNo need preoperative fasting more than 6 hours. Uptake 400ml high carbohydrate liquid diet 2 hours before ERCP.
Routine ERCP group
NO INTERVENTIONPreoperative fasting more than 6 hours as usual.
Interventions
400ml high carbohydrate liquid diet uptake 2 hours before ERCP
Eligibility Criteria
You may qualify if:
- ERCP patients,
- Age 18-85 years old.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Third Military Medical University
Chongqing, Chongqing Municipality, 400038, China
The first hospital of Lanzhou university
Lanzhou, Gansu, 730000, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Tongji medical collage,Huazhong University of science and technology
Wuhan, Hubei, 430022, China
Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
General Hospital of Ningxia Medical University
Yingchuan, Ningxia, 750004, China
The first affiliated hospital of Xi 'an jiaotong university
Xi'an, Shaanxi, 710061, China
Shandong jiaotong Hospital
Jinan, Shandong, 250000, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Taiyuan Iron and Steel Corporation Hospital
Taiyuan, Shanxi, 030008, China
Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, 300100, China
The First Teaching Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Shulan Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003, China
Related Publications (1)
Meng W, Leung JW, Wang Z, Li Q, Zhang L, Zhang K, Wang X, Wang M, Wang Q, Shao Y, Zhang J, Yue P, Zhang L, Zhu K, Zhu X, Zhang H, Hou S, Cai K, Sun H, Xue P, Liu W, Wang H, Zhang L, Ding S, Yang Z, Zhang M, Weng H, Wu Q, Chen B, Jiang T, Wang Y, Zhang L, Wu K, Yang X, Wen Z, Liu C, Miao L, Wang Z, Li J, Yan X, Wang F, Zhang L, Bai M, Mi N, Zhang X, Zhou W, Yuan J, Suzuki A, Tanaka K, Liu J, Nur U, Weiderpass E, Li X. Safety of high-carbohydrate fluid diet 2 h versus overnight fasting before non-emergency endoscopic retrograde cholangiopancreatography: A single-blind, multicenter, randomized controlled trial. Chin Med J (Engl). 2024 Jun 20;137(12):1437-1446. doi: 10.1097/CM9.0000000000002820. Epub 2023 Aug 24.
PMID: 37620294DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xun Li, M.D., Ph. D.
Hepatopancreatobiliary Surgery Institute of Gansu Province
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph. D, Direct of surgery
Study Record Dates
First Submitted
March 4, 2017
First Posted
March 9, 2017
Study Start
April 1, 2017
Primary Completion
April 17, 2021
Study Completion
April 17, 2021
Last Updated
August 9, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share