Aggressive Intravenous Hydration With Lactated Ringer's Solution Plus Rectal Indometacin Versus Rectal Indometacin Alone to Prevent Pancreatitis After Pancreatic Extracorporeal Shock Wave Lithotripsy: A Multicentre, Superiority, Randomised, Controlled Trial
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to determine whether combining aggressive intravenous hydration with indometacin is more effective at preventing pancreatitis after a Extracorporeal Shock Wave Lithotripsy (ESWL) than using indometacin alone. The study will involve patients who are scheduled to undergo ESWL for pancreatic stones. Participants will be randomly assigned to one of two groups: one will receive both the intravenous hydration and the rectal indometacin, while the other will receive only the rectal indometacin. The trial will be conducted at multiple centers, ensuring a broad and diverse patient population. The primary outcome of the study will be the incidence of pancreatitis after the ESWL procedure. This study is important because it could lead to a better understanding of how to prevent pancreatitis after ESWL, potentially improving patient outcomes and reducing the risk of serious complications.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• Patients with painful chronic pancreatitis eligible for P-ESWL treatment
• Ages between 18-85 years
• Providing informed consent
Locations
Other Locations
China
The Second Affiliated Hospital of Baotou Medical College
RECRUITING
Baotou
Peking Union Medical College Hospital
RECRUITING
Beijing
Hangzhou First People's Hospital
RECRUITING
Hangzhou
The Third Xiangya Hospital of Central South University
RECRUITING
Hunan
The First Hospital of Lanzhou University
NOT_YET_RECRUITING
Lanzhou
Qilu Hospital of Shandong University
RECRUITING
Shandong
Changhai Hospital
RECRUITING
Shanghai
Ruijin Hospital
RECRUITING
Shanghai
Shanghai Pudong New Area Gongli Hospital
RECRUITING
Shanghai
Yunnan University Affiliated Hospital
NOT_YET_RECRUITING
Yunnan
Contact Information
Primary
Liang-Hao Hu
lianghao-hu@hotmail.com
+8613817593520
Time Frame
Start Date:2025-10-13
Estimated Completion Date:2027-12-01
Participants
Target number of participants:1250
Treatments
Active_comparator: Rectal indometacin alone
Participants in this arm will receive a rectal administration of 100mg indometacin 30 minutes prior to ESWL. This group will not undergo aggressive hydration and will instead receive restricted hydration measures.
Experimental: Aggressive hydration with rectal Indometacin
Participants in this arm will also receive a rectal administration of 100mg indometacin 30 minutes before ESWL. In addition, they will undergo aggressive intravenous hydration using lactated Ringer's solution.
Collaborators: Qilu Hospital of Shandong University, Peking Union Medical College Hospital, Ruijin Hospital, The Second Affiliated Hospital of Baotou Medical College, LanZhou University, First People's Hospital of Hangzhou, The Third Xiangya Hospital of Central South University, Shanghai Pudong New Area Gongli Hospital, Affiliated Hospital of Yunnan University