Clinical trial NCT03075280: Pre-ERCP High Carbohydrate Drinks Improve Patients Recovery
Official title: Pre-ERCP Carbohydrate Drinks Improve Patients Recovery: an ERAS Protocol Attempts in ERCP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication
Keywords: ERCP
ERAS
complication
fatigue
high carbohydrate diet
Lead sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 1292
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Levels of fatigue (Fatigue Scale-14 scoring system)
timeFrame: 6 months
measure: Abdominal pain
timeFrame: 6 months
Secondary outcomes:
measure: The average incubation time
timeFrame: 6 months
measure: Successful cannulation time
timeFrame: 6 months
measure: Postoperative abdominal distention
timeFrame: 6 months
measure: Postoperative nausea and vomiting
timeFrame: 6 months
measure: Complications
timeFrame: 6 months
measure: Blood glucose
timeFrame: 6 months
measure: Intraoperative residues in stomach
timeFrame: 6 months
measure: The time eating
timeFrame: 6 months
measure: Length of hospital stay
timeFrame: 6 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Third Military Medical University
state: Chongqing
city: Lanzhou
country: China
facility: The first hospital of Lanzhou university
state: Gansu
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Wuhan
country: China
facility: Tongji medical collage,Huazhong University of science and technology
state: Hubei
city: Changsha
country: China
facility: Second Xiangya Hospital, Central South University
state: Hunan
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Yingchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xi'an
country: China
facility: The first affiliated hospital of Xi 'an jiaotong university
state: Shaanxi
city: Jinan
country: China
facility: Shandong jiaotong Hospital
state: Shandong
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Taiyuan Iron and Steel Corporation Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
state: Tianjin
city: Ürümqi
country: China
facility: The First Teaching Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Shulan Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Hepatopancreatobiliary Surgery Institute of Gansu Province
name: Xun Li, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: