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

Pancreatitis, Chronic Clinical Trial

— HYPER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05772234
• Other study ID #: HYPER20221204
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: Changhai Hospital
• Contact: Lianghao Hu, M.D.
• Phone: +86-13817593520
• Email: lianghao-hu[@]smmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1066
• Est. completion date: November 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

All patients with chronic pancreatitis aged between18 and 85 years who were eligible for treatment with ESWL for pancreatic stones were eligible for enrolment.

Exclusion Criteria:

1. Patients readmitted to the hospital for ESWL during the study period.

2. Acute pancreatitis in the last 3 days.

3. Signs of congestive heart failure, such as pitting edema or a New York Heart Association classification greater than class I heart failure. For patients = 70 years old, brain natriuretic peptide (BNP) and cardiac ultrasound would be performed before ESWL. Patients with BNP>100pg/ml or Ejection Fraction value<50% should be excluded.

4. Respiratory insufficiency (pO2 < 60 mmHg or saturation < 90% despite FiO2 of 30% or requiring mechanical ventilation). For patients = 70 years old, pulmonary function tests would be performed before ESWL. Patients with Forced Expiratory Volume in the first second (FEV1) <70% are excluded.

5. Severe liver disease (cirrhosis, liver abscess).

6. Patients receiving more than 1.5 mL/kg/h or 3 L/24 h of intravenous fluids in the 24 h before ESWL.

7. Hypotension (systolic blood pressure <90 mmHg or mean arterial pressure <70 mmHg).

8. Hypo- or hypernatremia (serum Na+ levels < 130 or > 150 mmol/L).

9. Pregnancy.

10. Unwilling or unable to provide consent.

Related Conditions & MeSH terms

• Pancreatic Duct Stone
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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.
• normal saline
Intravenous fluid infusion with normal saline (maximum of 1.5mL/kg per h or 3L per 24h).

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (10)

Lead Sponsor	Collaborator
Changhai Hospital	Affiliated Hospital of Yunnan University, First People's Hospital of Hangzhou, LanZhou University, Peking Union Medical College Hospital, Qilu Hospital of Shandong University, Ruijin Hospital, Shanghai Pudong New Area Gongli Hospital, The Second Affiliated Hospital of Baotou Medical College, The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (11)

Buxbaum JL, Freeman M, Amateau SK, Chalhoub JM, Coelho-Prabhu N, Desai M, Elhanafi SE, Forbes N, Fujii-Lau LL, Kohli DR, Kwon RS, Machicado JD, Marya NB, Pawa S, Ruan WH, Sheth SG, Thiruvengadam NR, Thosani NC, Qumseya BJ; (ASGE Standards of Practice Committee Chair). American Society for Gastrointestinal Endoscopy guideline on post-ERCP pancreatitis prevention strategies: summary and recommendations. Gastrointest Endosc. 2023 Feb;97(2):153-162. doi: 10.1016/j.gie.2022.10.005. Epub 2022 Dec 12. No abstract available. — View Citation

Choi JH, Kim HJ, Lee BU, Kim TH, Song IH. Vigorous Periprocedural Hydration With Lactated Ringer's Solution Reduces the Risk of Pancreatitis After Retrograde Cholangiopancreatography in Hospitalized Patients. Clin Gastroenterol Hepatol. 2017 Jan;15(1):86-92.e1. doi: 10.1016/j.cgh.2016.06.007. Epub 2016 Jun 14. — View Citation

Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20. — View Citation

Li BR, Liao Z, Du TT, Ye B, Zou WB, Chen H, Ji JT, Zheng ZH, Hao JF, Jiang YY, Hu LH, Li ZS. Risk factors for complications of pancreatic extracorporeal shock wave lithotripsy. Endoscopy. 2014 Dec;46(12):1092-100. doi: 10.1055/s-0034-1377753. Epub 2014 Sep 24. — View Citation

Park CH, Paik WH, Park ET, Shim CS, Lee TY, Kang C, Noh MH, Yi SY, Lee JK, Hyun JJ, Lee JK. Aggressive intravenous hydration with lactated Ringer's solution for prevention of post-ERCP pancreatitis: a prospective randomized multicenter clinical trial. Endoscopy. 2018 Apr;50(4):378-385. doi: 10.1055/s-0043-122386. Epub 2017 Dec 13. — View Citation

Qian YY, Ru N, Chen H, Zou WB, Wu H, Pan J, Li B, Xin L, Guo JY, Tang XY, Hu LH, Jin ZD, Wang D, Du YQ, Wang LW, Li ZS, Liao Z. Rectal indometacin to prevent pancreatitis after extracorporeal shock wave lithotripsy (RIPEP): a single-centre, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):238-244. doi: 10.1016/S2468-1253(21)00434-9. Epub 2022 Jan 25. — View Citation

Radadiya D, Devani K, Arora S, Charilaou P, Brahmbhatt B, Young M, Reddy C. Peri-Procedural Aggressive Hydration for Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis Prophylaxsis: Meta-analysis of Randomized Controlled Trials. Pancreatology. 2019 Sep;19(6):819-827. doi: 10.1016/j.pan.2019.07.046. Epub 2019 Jul 30. — View Citation

Skolarikos A, Alivizatos G, de la Rosette J. Extracorporeal shock wave lithotripsy 25 years later: complications and their prevention. Eur Urol. 2006 Nov;50(5):981-90; discussion 990. doi: 10.1016/j.eururo.2006.01.045. Epub 2006 Feb 7. — View Citation

Sperna Weiland CJ, Smeets XJNM, Kievit W, Verdonk RC, Poen AC, Bhalla A, Venneman NG, Witteman BJM, da Costa DW, van Eijck BC, Schwartz MP, Romkens TEH, Vrolijk JM, Hadithi M, Voorburg AMCJ, Baak LC, Thijs WJ, van Wanrooij RL, Tan ACITL, Seerden TCJ, Keulemans YCA, de Wijkerslooth TR, van de Vrie W, van der Schaar P, van Dijk SM, Hallensleben NDL, Sperna Weiland RL, Timmerhuis HC, Umans DS, van Hooft JE, van Goor H, van Santvoort HC, Besselink MG, Bruno MJ, Fockens P, Drenth JPH, van Geenen EJM; Dutch Pancreatitis Study Group. Aggressive fluid hydration plus non-steroidal anti-inflammatory drugs versus non-steroidal anti-inflammatory drugs alone for post-endoscopic retrograde cholangiopancreatography pancreatitis (FLUYT): a multicentre, open-label, randomised, controlled trial. Lancet Gastroenterol Hepatol. 2021 May;6(5):350-358. doi: 10.1016/S2468-1253(21)00057-1. Epub 2021 Mar 19. — View Citation

Tandan M, Nageshwar Reddy D, Talukdar R, Vinod K, Kiran SVVS, Santosh D, Gupta R, Ramchandani M, Lakhtakia S, Rakesh K, Manohar Reddy P, Basha J, Nabi Z, Jagtap N, Rao GV. ESWL for large pancreatic calculi: Report of over 5000 patients. Pancreatology. 2019 Oct;19(7):916-921. doi: 10.1016/j.pan.2019.08.001. Epub 2019 Aug 2. — View Citation

Wu BU, Hwang JQ, Gardner TH, Repas K, Delee R, Yu S, Smith B, Banks PA, Conwell DL. Lactated Ringer's solution reduces systemic inflammation compared with saline in patients with acute pancreatitis. Clin Gastroenterol Hepatol. 2011 Aug;9(8):710-717.e1. doi: 10.1016/j.cgh.2011.04.026. Epub 2011 May 12. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-ESWL pancreatitis	Post-ESWL pancreatitis is defined according to the 2012 Atlanta criteria. A diagnosis of post-ESWL pancreatitis is made if two of three of the following criteria are met: 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.	24 hours
Secondary	Severity of pancreatitis	Stratified as mild, moderate, or severe, mainly on the basis of length of hospitalization and need for invasive treatment.	1 month
Secondary	Incidence of other post-ESWL complications	Including bleeding, infection, steinstrasse, and perforation.	24 hours
Secondary	Incidence of fluid overload	Including pulmonary or peripheral edema and congestive heart failure.	24 hours