NCT05772234

Aggressive Intravenous Hydration With Lactated Ringer's Solution for Prevention of Post-ESWL Pancreatitis

Aggressive Intravenous Hydration With Lactated Ringer's Solution for Prevention of Post-ESWL Pancreatitis: A Multicenter, Prospective, Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,066 (actual)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to clarify whether aggressive intravenous hydration with lactated Ringer's solution could reduce the incidence of post-ESWL pancreatitis in patients with chronic pancreatitis.

Detailed description

Chronic pancreatitis (CP) is a disease caused by genetic and environmental factors that lead to progressive fibrosis of the pancreatic tissue, resulting in irreversible damage to the structure and function of the pancreas. The incidence of pancreatic duct stones in CP is as high as 90%. Stones can lead to pancreatic duct obstruction, pancreatic parenchymal hypertension and ischemia, inducing frequent abdominal pain and accelerating the decline of pancreatic function, therefore, removal of pancreatic duct stones is important for relieving CP symptoms. For large stones and complex stones, pancreatic extracorporeal shock wave lithotripsy (P-ESWL) was recommended. Acute pancreatitis is the most common complication after P-ESWL with an incidence of 6.3-12.5%, which result in prolonged hospitalization, increased medical costs, and can be life-threatening. There are few studies on the prevention of postoperative pancreatitis after P- ESWL. Only one prospective randomized controlled study found the role of NSAIDs in the prevention of acute pancreatitis after ESWL, and preoperative use of rectal indomethacin reduced post-ESWL pancreatitis from 12% to 9%. ERCP placement of pancreatic duct stent is one of the effective methods to prevent post-ERCP pancreatitis. However, studies have shown that pancreatic duct stenting before ESWL is not effective in preventing acute pancreatitis after P-ESWL. More research is needed in the prevention and treatment of pancreatitis after P-ESWL. There have been more high-quality studies on the prevention of post-ERCP pancreatitis. In addition to NSAIDs, several prospective randomized controls have found that perioperative high-dose lactated Ringerolysis (LRS) hydration is effective in preventing acute pancreatitis after ERCP. In a meta-analysis, active hydration of LRS was found to reduce post-ERCP pancreatitis from 13% to 6%. Based on above findings, international guidelines recommend aggressive perioperative LRS hydration to reduce the risk of post-ERCP pancreatitis. Previous studies have suggested various mechanisms leading to post-ERCP pancreatitis, including mechanical injury, chemical injury, hydrostatic injury, and infection. Given the potentially similar pathogenesis of postoperative pancreatitis, we propose to conduct a randomized controlled trial to investigate the efficacy of active hydration of lactated Ringer's solution for the prevention of post-ESWL pancreatitis.

Conditions

• Pancreatitis, Chronic
• Pancreatic Duct Stone

Interventions

Type	Name	Description
DRUG	Lactated ringers solution	Intravenous 20 mL/kg Ringer's lactate solution within 60 min from the start of ESWL, directly followed by 3 mL/kg per h for 8 h.
DRUG	normal saline	Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h).

Timeline

• Start date: 2023-11-17
• Primary completion: 2025-03-18
• Completion: 2025-03-23
• First posted: 2023-03-16
• Last updated: 2025-03-28

Locations

1 site across 1 country: China