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

Fasting Clinical Trial

— SHEEL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05669573
• Other study ID #: SHEEL202210
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: May 2023
• Source: Changhai Hospital
• Contact: Liang-hao Hu, MD
• Phone: +86-13817593520
• Email: ianghao-hu[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• ESWL
• Fasting
• Pancreatic Duct Stone

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
Changhai Hospital	First People's Hospital of Hangzhou, LanZhou University, Ruijin Hospital, Shanghai Pudong New Area Gongli Hospital, The Second Affiliated Hospital of Baotou Medical College

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	within 24 hours after ESWL
Secondary	the incidence of other post-ESWL complications	Other post ESWL complications includes bleeding, infection, steinstrasse, and perforation.	within 24 hours after ESWL
Secondary	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.	within 24 hours after ESWL
Secondary	abdominal pain relief rate	Use the Visual Analogue Scale (VAS). VAS can be calculated ranging from 0 (no pain) to 10 (severe pain).	within 24 hours after ESWL
Secondary	hunger relief rate	Use the Visual Analogue Scale (VAS). VAS can be calculated ranging from 0 (not hungry at all) to 10 (hungriest possible).	within 24 hours after ESWL