Skip to main content
OpenTrials
Completed

NCT Number: NCT05669573

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Duct Stone Behavior ESWL Fasting Feeding Behavior

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. the incidence of post-ESWL pancreatitis

    Time frame: within 24 hours after ESWL

    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.

Secondary outcomes

  1. the severity of post-ESWL pancreatitis

    Time frame: within 24 hours after ESWL

    stratified as mild, moderate, or severe, mainly on the basis of length of hospitalisation and need for invasive treatment

  2. the incidence of other post-ESWL complications

    Time frame: within 24 hours after ESWL

    Other post ESWL complications includes bleeding, infection, steinstrasse, and perforation.

  3. the transient adverse events

    Time frame: within 24 hours after ESWL

    Transient adverse events were defined as transient injuries caused by shock waves that required no medical intervention and did not prolong hospitalisation, including asymptomatic hyperamylasaemia, haematuria, and acute gastrointestinal mucosal injury (eg, haematemesis, melena, or haematochezia) caused by ESWL.

  4. abdominal pain relief rate

    Time frame: within 24 hours after ESWL

    Use the Visual Analogue Scale (VAS). VAS can be calculated ranging from 0 (no pain) to 10 (severe pain).

  5. hunger relief rate

    Time frame: within 24 hours after ESWL

    Use the Visual Analogue Scale (VAS). VAS can be calculated ranging from 0 (not hungry at all) to 10 (hungriest possible).

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

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

Registry information

Official study title

Safety of 6 Hours Feeding After Extracorporeal Shock Wave Lithotripsy of Pancreatic Stone: a Multicentre, Open-label, Randomized, Controlled Trial

Acronym: SHEEL

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2023
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.