Clinical trial NCT05669573: Safety of 6 Hours Feeding After Extracorporeal Shock Wave Lithotripsy of Pancreatic Stone
Official title: Safety of 6 Hours Feeding After Extracorporeal Shock Wave Lithotripsy of Pancreatic Stone: a Multicentre, Open-label, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Duct Stone
ESWL
Fasting
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Shanghai Pudong New Area Gongli Hospital
name: First People's Hospital of Hangzhou
name: LanZhou University
name: The Second Affiliated Hospital of Baotou Medical College
First posted: 2023-01-03
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the incidence of post-ESWL pancreatitis
timeFrame: within 24 hours after ESWL
Secondary outcomes:
measure: the severity of post-ESWL pancreatitis
timeFrame: within 24 hours after ESWL
measure: the incidence of other post-ESWL complications
timeFrame: within 24 hours after ESWL
measure: the transient adverse events
timeFrame: within 24 hours after ESWL
measure: abdominal pain relief rate
timeFrame: within 24 hours after ESWL
measure: hunger relief rate
timeFrame: within 24 hours after ESWL
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Liang-hao Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.