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7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients

Sponsor
Air Force Military Medical University, China (Other)
Overall Status
Unknown status
CT.gov ID
NCT04145336
Collaborator
(none)
800
Enrollment
1
Location
2
Arms
12.6
Anticipated Duration (Months)
63.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Acute pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). The incidence of post-ERCP pancreatitis (PEP) is estimated to be 10% to 15% in high-risk patients. Current guidelines recommend using pancreatic duct stent (PDS) for PEP prevention in high-risk patients, but it is not clear whether stent length will affect the effect of PEP prevention. The longer PDS will remain in the pancreatic duct for a longer period of time, thereby ensuring prolonged decompression with subsequent lowering of the risk for PEP. Findings from two retrospective studies showed that longer PDS was more effective in reducing the risk of post-ERCP hyperamylasemia and the frequency of PEP compared with the shorter PDS. We conducted this trial to test whether 7cm PDS was superior to 5cm PDS in PEP prevention in high-risk patients.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
7 cm vs. 5 cm Pancreatic Stents for the Prevention of Post-ERCP Pancreatitis in High-risk Patients: a Multicentre, Single-blinded, Randomised Controlled Trial
Actual Study Start Date :
Oct 15, 2019
Anticipated Primary Completion Date :
Oct 31, 2020
Anticipated Study Completion Date :
Oct 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 5cm PDS group

All patients in this group receive 5cm 5-Fr PDS.

Device: 5cm 5-Fr PDS
High-risk patients receive 5cm 5-Fr PDS

Drug: Indomethacin
All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.
Experimental: 7cm PDS group

All patients in this group receive 7cm 5-Fr PDS.

Device: 7cm 5-Fr PDS
High-risk patients receive 7cm 5-Fr PDS

Drug: Indomethacin
All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.

Outcome Measures

Primary Outcome Measures

  1. Post-ERCP Pancreatitis [14 days]

    The diagnosis of PEP was established if there was new onset of upper abdominal pain associated with an increased serum amylase level of at least 3 times the upper limit of normal range at 24 hours after the procedure, and hospitalization for at least 2 nights.

Secondary Outcome Measures

  1. Moderate to severe PEP [14 days]

    The severity classification of pancreatitis was defined according to the criteria of Cotton et al and the revised Atlanta criteria.

  2. Other complications of ERCP [14 days]

    Other complications include post sphincterotomy bleeding, biliary infection, perforation, and any adverse outcomes possibly related to ERCP that required hospital admission or a prolonged hospital stay for further management.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Un-intentional pancreatic duct cannulation:

  • 2 or more times;

  • 1 time with more than 10 minutes cannulation.

  1. Double-wire technique;

  2. High-risk patients:

met at least 1 of the major criteria

  • Clinical suspicion of sphincter of Oddi dysfunction;

  • Pancreatic sphincterotomy

  • Delayed precut sphincterotomy

  • ≥ 8 cannulation attempts

  • Pneumatic dilatation of an intact biliary sphincter

  • Ampullectomy

or met at least 2 or more of the minor criteria

  • Age < 50;

  • Female;

  • Normal TBIL;

  • ≥ 3 injections of contrast into the pancreatic duct with ≥ 1 injection to the tail of the pancreas;

Exclusion Criteria:

  • Therapeutic PDS;

  • Acute pancreatitis within 3 days;

  • With a history of pancreatic surgery or biliary-enteric anastomosis;

  • Pregnant or breastfeeding women;

  • unwilling or inability to provide consent.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xijing Hospital of Digestive Diseases Xi'an Shanxi China 710032

Sponsors and Collaborators

  • Air Force Military Medical University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Yanglin Pan, Associated professor, Air Force Military Medical University, China
ClinicalTrials.gov Identifier:
NCT04145336
Other Study ID Numbers:
  • KY20191010-2
First Posted:
Oct 30, 2019
Last Update Posted:
Oct 30, 2019
Last Verified:
Oct 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yanglin Pan, Associated professor, Air Force Military Medical University, China
ERCP
PEP
Post-ERCP pancreatitis
Pancreatic duct stent
Additional relevant MeSH terms:
Pancreatitis
Indomethacin

Study Results

No Results Posted as of Oct 30, 2019