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

NCT05669573 | Completed DMC

• 1 other identifier: SHEEL202210
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Duct Stone; ESWL; Fasting

Outcome Measures

Primary Outcomes (1)

• the incidence of post-ESWL pancreatitis

  A diagnosis of post-ESWL pancreatitis was thus made if two of three of the following criteria were met, in accordance with the revised Atlanta international consensus: pain consistent with pancreatitis; amylase or lipase of at least three times the upper normal limit within 24 h of the procedure; or characteristic findings on imaging.

  within 24 hours after ESWL

Secondary Outcomes (5)

• the severity of post-ESWL pancreatitis

  within 24 hours after ESWL

• the incidence of other post-ESWL complications

  within 24 hours after ESWL

• the transient adverse events

  within 24 hours after ESWL

• abdominal pain relief rate

  within 24 hours after ESWL

• hunger relief rate

  within 24 hours after ESWL

Study Arms (2)

Early feeding group

EXPERIMENTAL

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.

Procedure: Early feeding group

Standard fasting group

ACTIVE COMPARATOR

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.

Procedure: Standard fasting group

Interventions

Early feeding group 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.

Early feeding group

Standard fasting group PROCEDURE

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

Standard fasting group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic pancreatitis who completed ESWL.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead
• Ruijin Hospital: collaborator
• Shanghai Pudong New Area Gongli Hospital: collaborator
• First People's Hospital of Hangzhou: collaborator
• LanZhou University: collaborator
• The Second Affiliated Hospital of Baotou Medical College: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

Location

Related Publications (1)

• 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.

  PMID: 31238312 BACKGROUND

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Liang-hao Hu, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 3, 2023
• Study Start: May 29, 2023
• Primary Completion: April 17, 2024
• Study Completion: April 22, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)