A Prospective Trial of Aggressive Hydration Strategy to Reduce Post-ERCP Pancreatitis

NCT02308891 | Completed DMC

• 1 other identifier: 2014-09-011
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 3

Brief Summary

Postendoscopic retrograde cholangiopancreatography pancreatitis is the most frequent and serious complication of ERCP procedures, occurring in approximately 5-15% of unselected patients. Pharmacologic prevention of post-ERCP pancreatitis has been the topic of several investigations in recent years. Hydration is considered a mainstay of treatment for acute pancreatitis. We perform multicenter, prospective, randomized trial to investigate whether intravenous vigorous hydration with lactated Ringer's solution reduces the risk of post-ERCP pancreatitis. Inclusion criteria : consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP will be recruited. Patients will be randomly assigned in a 1:1 ratio to receive either vigorous hydration (treatment arm) or standard hydration (standard arm). Randomization will be performed in a double blinded fashion using computer-generated random numbers. Treatment arm (vigorous hydration arm);

• Initial bolus of lactated Ringer's solution at 10 mL/kg over 1 hour prior to ERCP
• Intravenous lactated Ringer's solution at a rate of 3 mL/kg/h during the procedure and continued for 8 hours.
• At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10 mL/Kg over 1hour Standard arm (standard hydration arm);
• Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5 ml/kg/h during the procedure and for 8hours after ERCP. The primary endpoint was development of post-ERCP pancreatitis, which define as increased pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three times the upper limit of normal). The secondary endpoint included the development of asymptomatic hyperamylasemia, severity of pancreatitis, and fluid overload.

Conditions

Post-ERCP Acute Pancreatitis

Keywords

pancreatitis; ERCP

Outcome Measures

Primary Outcomes (1)

• development of post-ERCP pancreatitis

  define as increased pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three times the upper limit of normal).

  48 hours

Secondary Outcomes (3)

• development of hyperamylasemia

  48 hours

• severity of pancreatitis

  3 months

• any signs of fluid overload

  48 hours

Study Arms (2)

vigorous hydration arm

EXPERIMENTAL

Patients will be randomly allocated to vigorous hydration arm. Patients in the vigorous hydration arm will receive fluids via infusion by the following protocol. * Initial bolus of lactated Ringer's solution at 10mL/kg over 1 hour prior to ERCP * Intravenous lactated Ringer's solution at a rate of 3mL/kg/h during the procedure and continued for 8 hours. * At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10mL/Kg over 1hour

Drug: lactated Ringer's solution (vigorous hydration arm); Device: endoscopic retrograde cholangiopancreatography (ERCP)

standard hydration arm

ACTIVE COMPARATOR

Patients will be randomly allocated to standard hydration arm. Patients in the standard hydration arm will receive fluids via infusion by the following protocol. \- Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5ml/kg/h during the procedure and for 8hours after ERCP.

Drug: lactated Ringer's solution (standard hydration arm); Device: endoscopic retrograde cholangiopancreatography (ERCP)

Interventions

lactated Ringer's solution (vigorous hydration arm) DRUG

* Initial bolus of lactated Ringer's solution at 10mL/kg over 1 hour prior to ERCP * Intravenous lactated Ringer's solution at a rate of 3mL/kg/h during the procedure and continued for 8 hours. * At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10mL/Kg over 1hour

vigorous hydration arm

lactated Ringer's solution (standard hydration arm) DRUG

\- Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5ml/kg/h during the procedure and for 8hours after ERCP.

standard hydration arm

endoscopic retrograde cholangiopancreatography (ERCP) DEVICE

endoscopic retrograde cholangiopancreatography

standard hydration arm; vigorous hydration arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consecutive patients older than 18 years who are scheduled to undergo diagnostic or therapeutic ERCP will be recruited

You may not qualify if:

• Patients will be excluded if they have acute pancreatitis during the 2 weeks before ERCP, a history of chronic pancreatitis, previous sphincterotomy, or if they refuse to participate the study protocol. Patients will be also excluded if they undergo ERCP, for procedures such as stone removal following previous sphincterotomy, change or removal of previous biliary stents, or surveillance biopsy after endoscopic papillectomy without pancreatography, which are considered to carry minimal risks of post-ERCP pancreatitis. Patients with high risk of fluid overload (heart failure, more than NYHA II; renal insufficiency, creatinine clearance \<40ml/min; liver cirrhosis; or hypoxemia, SaO2 \<90%; signs of pulmonary edema) are excluded.

Sponsors & Collaborators

• Dankook University: lead
• Wonkwang University: collaborator
• University of Ulsan: collaborator

Study Sites (3)

Dankook University College of Medicine

Cheonan, Chungcheongnam-do, 330-715, South Korea

Location

Wonkwang University

Iksan, Jeollabukdo, South Korea

Location

University of Ulsan, Ulsa University Hospital

Ulsan, South Korea

Location

Related Publications (1)

• 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.

  PMID: 27311618 DERIVED

MeSH Terms

Conditions

Pancreatitis

Interventions

Ringer's Lactate; Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jun Ho Choi, MD

  Dankook University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 4, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 5, 2016

Record last verified: 2016-08

Locations

KR (3)