Trial record 19 of 334 for:    pancreatitis

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Dankook University
Sponsor:
Collaborators:
Wonkwang University
University of Ulsan
Information provided by (Responsible Party):
Jun Ho Choi, Dankook University
ClinicalTrials.gov Identifier:
NCT02308891
First received: November 26, 2014
Last updated: December 4, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Post-ERCP Acute Pancreatitis
Drug: lactated Ringer's solution (vigorous hydration arm)
Drug: lactated Ringer's solution (standard hydration arm)
Device: endoscopic retrograde cholangiopancreatography (ERCP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Multicenter Prospective Randomized Trial of Aggressive Hydration Strategy to Reduce Post-ERCP Pancreatitis

Resource links provided by NLM:


Further study details as provided by Dankook University:

Primary Outcome Measures:
  • development of post-ERCP pancreatitis [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    define as increased pancreatic pain (more than 3 on a visual analogue pain scale) and hyperamylasemia (three times the upper limit of normal).


Secondary Outcome Measures:
  • development of hyperamylasemia [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    hyperamylasemia (three times the upper limit of normal).

  • severity of pancreatitis [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    pancreatitis criteria

  • any signs of fluid overload [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    pulmonary or peripheral edema


Estimated Enrollment: 510
Study Start Date: November 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vigorous hydration arm

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)
  • 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
Other Name: lactated Ringer's solution (vigorous hydration arm)
Device: endoscopic retrograde cholangiopancreatography (ERCP)
endoscopic retrograde cholangiopancreatography
Active Comparator: standard hydration arm

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)
- 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.
Other Name: lactated Ringer's solution (standard hydration arm)
Device: endoscopic retrograde cholangiopancreatography (ERCP)
endoscopic retrograde cholangiopancreatography

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02308891

Contacts
Contact: Jun Ho Choi, MD 82-10-7177-6152 mdcjh78@gmail.com
Contact: Hong Ja Kim, MD hjkimjung@hotmail.com

Locations
Korea, Republic of
Dankook University College of Medicine Recruiting
Cheonan, Chungcheongnam-do, Korea, Republic of, 330-715
Contact: Jun Ho Choi, MD    82-10-7177-6152    mdcjh78@gmail.com   
Wonkwang University Recruiting
Iksan, Jeollabukdo, Korea, Republic of
Contact: Tae Hyeon Kim, MD    82-10-2676-1051    kth@wonkwang.ac.kr   
University of Ulsan, Ulsa University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Byung Uk Lee, MD       heliantus@naver.com   
Sponsors and Collaborators
Dankook University
Wonkwang University
University of Ulsan
Investigators
Principal Investigator: Jun Ho Choi, MD Dankook University College of Medicine
  More Information

No publications provided

Responsible Party: Jun Ho Choi, Assistant Professor, Dankook University
ClinicalTrials.gov Identifier: NCT02308891     History of Changes
Other Study ID Numbers: 2014-09-011
Study First Received: November 26, 2014
Last Updated: December 4, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Dankook University:
pancreatitis
ERCP

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2015