An interventional study of Early feeding group and Standard fasting group in Pancreatic Duct Stone, ESWL and Fasting, sponsored by Changhai Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Health services research
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.
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.
392 studies on the registry are indexed under Fasting; 63 are open to participants now.
This study's enrollment of 216 is above the median of 45 across 311 interventional studies indexed under Fasting.
Browse Fasting studies →Changhai Hospital is the lead sponsor of 355 studies on the registry; 137 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Patients in the standard fasting group were fasted for 24 hours after the first ESWL operation, and close observation during this fasting period.
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.
Time frame: within 24 hours after ESWL
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
Time frame: within 24 hours after ESWL
the incidence of other post-ESWL complications
Other post ESWL complications includes bleeding, infection, steinstrasse, and perforation.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: within 24 hours after ESWL
Plan to share: No
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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