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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fasting; Pancreatic Duct Stone; ESWL
• Intervention / Treatment: Procedure: Early feeding group; Procedure: Standard fasting group

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 Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liang-hao Hu, MD; Phone Number: +86-13817593520; Email: ianghao-hu@smmu.edu.cn
• Study Contact Backup: Name: Zhao-shen Li, MD; Phone Number: +86-13901960921; Email: zhaoshen-li@hotmail.com

Study Locations

• China
  • Shanghai, China, 200433
    • Changhai Hospital
    • Principal Investigator: Fan Wang
    • Principal Investigator: Dan Wang
    • Principal Investigator: Teng Wang
    • Contact: Zhao-shen Li, MD; Phone Number: +86-13901960921; Email: zhaoshen-li@hotmail.com
    • Contact: Liang-hao Hu, MD; Phone Number: +86-13817593520; Email: lianghao-hu@smmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. 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 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.
Active Comparator: 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. 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 standard fasting group were fasted for 24 hours after the first ESWL operation, and close observation during this fasting period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
the incidence of other post-ESWL complications	Other post ESWL complications includes bleeding, infection, steinstrasse, and perforation.	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.	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).	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).	within 24 hours after ESWL

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: First People's Hospital of Hangzhou; LanZhou University; Ruijin Hospital; The Second Affiliated Hospital of Baotou Medical College; Shanghai Pudong New Area Gongli Hospital
• Investigators: Principal Investigator: Liang-hao Hu, MD, Changhai Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 24, 2023
• Primary Completion (Anticipated): August 31, 2023
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: December 20, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): January 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Calculi
• Other Study ID Numbers: SHEEL202210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No