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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05669573
Other study ID # SHEEL202210
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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