Pancreatic Duct StoneSHEELNCT05669573
Safety of 6 Hours Feeding After Extracorporeal Shock Wave Lithotripsy of Pancreatic Stone
A study testing Early feeding group and Standard fasting group in people with Pancreatic Duct Stone and ESWL, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Duct Stone, ESWL, Fasting
- What is being tested?
- Early feeding group and Standard fasting group
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2023to 22 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic pancreatitis who completed ESWL.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of 6 Hours Feeding After Extracorporeal Shock Wave Lithotripsy of Pancreatic Stone: a Multicentre, Open-label, Randomized, Controlled Trial
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.
Read the 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
- Being tested
- Early feeding group, Standard fasting group
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early feeding groupProcedure or surgery
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 groupProcedure or surgery
Patients in the standard fasting group were fasted for 24 hours after the first ESWL operation, and close observation during this fasting period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Standard fasting group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 24 hours after ESWL
Secondary outcomes (5)
the severity of post-ESWL pancreatitis
stratified as mild, moderate, or severe, mainly on the basis of length of hospitalisation and need for invasive treatment
Measured: within 24 hours after ESWL
the incidence of other post-ESWL complications
Other post ESWL complications includes bleeding, infection, steinstrasse, and perforation.
Measured: within 24 hours after ESWL
the transient adverse events
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.
Measured: within 24 hours after ESWL
abdominal pain relief rate
Use the Visual Analogue Scale (VAS). VAS can be calculated ranging from 0 (no pain) to 10 (severe pain).
Measured: within 24 hours after ESWL
hunger relief rate
Use the Visual Analogue Scale (VAS). VAS can be calculated ranging from 0 (not hungry at all) to 10 (hungriest possible).
Measured: within 24 hours after ESWL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start29 May 2023
- Primary completion17 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Duct StoneStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Pudong New Area Gongli Hospital, First People's Hospital of Hangzhou, LanZhou University, The Second Affiliated Hospital of Baotou Medical College
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
- Investigators
- Liang-hao Hu, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669573
- Sponsor's protocol ID
- SHEEL202210
- Acronym
- SHEEL
- Status last verified
- Mar 2025
- First submitted
- 20 Dec 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31238312
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of 6 Hours Feeding After Extracorporeal Shock Wave Lithotripsy of Pancreatic Stone: a Multicentre, Open-label, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05669573
- Acronym / sponsor ID
- SHEEL / SHEEL202210
- Conditions
- Pancreatic Duct Stone, ESWL, Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Shanghai Pudong New Area Gongli Hospital, First People's Hospital of Hangzhou, LanZhou University, The Second Affiliated Hospital of Baotou Medical College
- Study start
- 29 May 2023 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 3 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early feeding group | Experimental | Procedure: Early feeding groupPatients 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. |
| Standard fasting group | Active comparator | Procedure: Standard fasting groupPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic pancreatitis who completed ESWL.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early feeding groupPatients 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. | Procedure or surgery | Early feeding group |
| Standard fasting groupPatients in the standard fasting group were fasted for 24 hours after the first ESWL operation, and close observation during this fasting period. | Procedure or surgery | Standard fasting group |
Primary outcome
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.
5 secondary outcomes
the severity of post-ESWL pancreatitis
Time frame: within 24 hours after ESWL
the incidence of other post-ESWL complications
Time frame: within 24 hours after ESWL
the transient adverse events
Time frame: within 24 hours after ESWL
abdominal pain relief rate
Time frame: within 24 hours after ESWL
hunger relief rate
Time frame: within 24 hours after ESWL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Background: PubMed 31238312Hao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang-hao Hu, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early feeding group and Standard fasting group in people with Pancreatic Duct Stone and ESWL, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of post-ESWL pancreatitis (time frame: within 24 hours after ESWL). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05669573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.