Safety of 6 Hours Feeding After Extracorporeal Shock Wave Lithotripsy of Pancreatic Stone

NCT ID: NCT05669573

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-29
• Study Completion Date: 2024-04-22

Brief Summary

The purpose of this study is to evaluate the safety of eating 6 hours after Extracorporeal Shock Wave Lithotripsy (ESWL). At present, ESWL and Endoscopic Retrograde Cholangiopancreatography (ERCP) are the routine ways to treat pancreatic duct stones. For large stones (diameter > 5mm) , ESWL often needs to be performed many times. In clinical practice, fasting for 24 hours after surgery is often used, but long-term fasting brings strong discomfort to patients. However, the consensus for initiation timing of oral nutrition has not yet been established after ESWL. Thus, we design this trial to evaluate the safety of early feeding based on 6 hours parameter instead of the consensus definition.

Detailed Description

In recent years, studies have shown that early recovery of enteral nutrition has significant benefits for patients. Early recovery of oral feeding and drinking as well as early oral supplementary nutrition after surgery can promote the recovery of intestinal motor function, help maintain intestinal mucosal function, prevent postoperative flora disorder and diarrhea, shorten postoperative hospital stay, and improve postoperative anxiety of patients.This study mainly evaluated the safety of feeding 6 hours after ESWL, including the risk of post-ESWL pancreatitis and other adverse events, as well as the length of hospital stay, medical expenses, pain, etc. This research conclusion is helpful to provide more scientific and reasonable fasting time for patients after ESWL, improve patient comfort, reduce the risk of adverse events, shorten hospital stay, save medical expenses, and guide clinical practice.

Conditions

Pancreatic Duct Stone; ESWL; Fasting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Early feeding group

Patients in the early diet group started oral intake 6 hours after ESWL of the day of procedure with a soft diet comprised 200 mL with 170 kilocalories. Observe closely until 24h, and then continue to fasting until the next ESWL/ERCP or change the diet to the general diet according to the actual clinical needs.

Group Type: EXPERIMENTAL

Early feeding group

Intervention Type: PROCEDURE

Patients in the early diet group started oral intake 6 hours after ESWL of the day of procedure with a soft diet comprised 200 mL with 170 kilocalories.

Standard fasting group

Patients in the standard fasting group were fasted for 24 hours after the first ESWL operation, and close observation during this fasting period. After 24 hours, according to the actual clinical needs, continue to fast until the next ESWL/ERCP operation, or change the diet to a general diet.

Group Type: ACTIVE_COMPARATOR

Standard fasting group

Intervention Type: PROCEDURE

Patients in the standard fasting group were fasted for 24 hours after the first ESWL operation, and close observation during this fasting period.

Interventions

Early feeding group

Patients in the early diet group started oral intake 6 hours after ESWL of the day of procedure with a soft diet comprised 200 mL with 170 kilocalories.

Intervention Type: PROCEDURE

Standard fasting group

Patients in the standard fasting group were fasted for 24 hours after the first ESWL operation, and close observation during this fasting period.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with chronic pancreatitis who completed ESWL.

Exclusion Criteria

• Readmitted to the hospital during enrollment of the study;
• Cannot eat or rely on jejunal nutrition tube to give total parenteral nutrition for various reasons;
• With acute pancreatitis, perforation, infection, bleeding, steinstrasse and other complications and other serious clinical adverse events within 6 hours after ESWL;
• Suspected or confirmed malignancy
• Pancreatic ascites;
• Coagulation dysfunction;
• Taking chemotherapy drugs and immunosuppressants for a long time;
• Acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis (including biliary pancreatitis);
• Pregnant or breastfeeding women;
• Patients who refused to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: collaborator

Shanghai Pudong New Area Gongli Hospital

OTHER

Sponsor Role: collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role: collaborator

LanZhou University

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Baotou Medical College

OTHER

Sponsor Role: collaborator

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhaoshen Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liang-hao Hu, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Changhai Hospital

Shanghai, , China

Countries

China

References

Hao L, Liu Y, Xie T, Wang T, Guo HL, Pan J, Wang D, Bi YW, Ji JT, Xin L, Du TT, Lin JH, Zhang D, Zeng XP, Zou WB, Chen H, Li BR, Liao Z, Cong ZJ, Shi RH, Li ZS, Hu LH. Risk Factors and Nomogram for Pancreatic Stone Formation in Chronic Pancreatitis over a Long-Term Course: A Cohort of 2,153 Patients. Digestion. 2020;101(4):473-483. doi: 10.1159/000500941. Epub 2019 Jun 25.

Reference Type: BACKGROUND

PMID: 31238312 (View on PubMed)

Other Identifiers

SHEEL202210

Identifier Type: -

Identifier Source: org_study_id