Pre-ERCP High Carbohydrate Drinks Improve Patients Recovery

Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075280
• Other study ID #: HSIGansu
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: April 17, 2021

Study information

• Verified date: August 2022
• Source: Hepatopancreatobiliary Surgery Institute of Gansu Province
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1292
• Est. completion date: April 17, 2021
• Est. primary completion date: April 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 ? and Roux-en-Y,

• Pregnant women,

• Unwillingness or inability to consent for the study.

Related Conditions & MeSH terms

• Complication

Intervention

Procedure:
• 400ml high carbohydrate liquid diet before ERCP
400ml high carbohydrate liquid diet uptake 2 hours before ERCP

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Jilin
China	Second Xiangya Hospital, Central South University	Changsha	Hunan
China	Third Military Medical University	Chongqing	Chongqing
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Shulan Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Shandong jiaotong Hospital	Jinan	Shandong
China	The first hospital of Lanzhou university	Lanzhou	Gansu
China	Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Taiyuan Iron and Steel Corporation Hospital	Taiyuan	Shanxi
China	Tianjin Nankai Hospital	Tianjin	Tianjin
China	The First Teaching Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Tongji medical collage,Huazhong University of science and technology	Wuhan	Hubei
China	The first affiliated hospital of Xi 'an jiaotong university	Xi'an	Shaanxi
China	General Hospital of Ningxia Medical University	Yingchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
Hepatopancreatobiliary Surgery Institute of Gansu Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Abdominal pain	Pain score (scores:1-10)	6 months
Secondary	The average incubation time	The time of total procedure	6 months
Secondary	Successful cannulation time	From first achieve the papilla to success cannulation	6 months
Secondary	Postoperative abdominal distention	Distention uncomfortable	6 months
Secondary	Postoperative nausea and vomiting	Nausea or vomiting after procedure	6 months
Secondary	Complications	Pancreatitis, cholangitis, bleeding, aspiration, et,al.	6 months
Secondary	Blood glucose	Intra-operative blood glucose and 2 hours' blood glucose after procedure	6 months
Secondary	Intraoperative residues in stomach	The volume of stomach residues	6 months
Secondary	The time eating	The time of eager to eat after procedure	6 months
Secondary	Length of hospital stay	Days of hospital stay	6 months