Pre-ERCP High Carbohydrate Drinks Improve Patients Recovery

NCT ID: NCT03075280

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2021-04-17

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.

Conditions

Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High carbohydrate liquid diet

No need preoperative fasting more than 6 hours. Uptake 400ml high carbohydrate liquid diet 2 hours before ERCP.

Group Type: EXPERIMENTAL

400ml high carbohydrate liquid diet before ERCP

Intervention Type: PROCEDURE

400ml high carbohydrate liquid diet uptake 2 hours before ERCP

Routine ERCP group

Preoperative fasting more than 6 hours as usual.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

400ml high carbohydrate liquid diet before ERCP

400ml high carbohydrate liquid diet uptake 2 hours before ERCP

Intervention Type: PROCEDURE

Other Intervention Names

Routine ERCP

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role: lead

Responsible Party

Xun Li

M.D., Ph. D, Direct of surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xun Li, M.D., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Hepatopancreatobiliary Surgery Institute of Gansu Province

Locations

Third Military Medical University

Chongqing, Chongqing Municipality, China

The first hospital of Lanzhou university

Lanzhou, Gansu, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Tongji medical collage,Huazhong University of science and technology

Wuhan, Hubei, China

Second Xiangya Hospital, Central South University

Changsha, Hunan, China

The First Hospital of Jilin University

Changchun, Jilin, China

General Hospital of Ningxia Medical University

Yingchuan, Ningxia, China

The first affiliated hospital of Xi 'an jiaotong university

Xi'an, Shaanxi, China

Shandong jiaotong Hospital

Jinan, Shandong, China

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Taiyuan Iron and Steel Corporation Hospital

Taiyuan, Shanxi, China

Tianjin Nankai Hospital

Tianjin, Tianjin Municipality, China

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Shulan Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37620294 (View on PubMed)

Other Identifiers

HSIGansu

Identifier Type: -

Identifier Source: org_study_id