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

Not Applicable

• Conditions: Post-ERCP Acute Pancreatitis
• Interventions: Device: 7cm 5-Fr PDS; Device: 5cm 5-Fr PDS; Drug: Indomethacin

• Registration Number: NCT04145336
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-10-15
• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-28
• Last Update Submitted: 2019-10-28
• Study First Posted: 2019-10-30
• Last Update Posted: 2019-10-30
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. Un-intentional pancreatic duct cannulation:

   • 2 or more times;
   • 1 time with more than 10 minutes cannulation.

2. Double-wire technique;

3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7cm PDS group	7cm 5-Fr PDS	All patients in this group receive 7cm 5-Fr PDS.
5cm PDS group	Indomethacin	All patients in this group receive 5cm 5-Fr PDS.
5cm PDS group	5cm 5-Fr PDS	All patients in this group receive 5cm 5-Fr PDS.
7cm PDS group	Indomethacin	All patients in this group receive 7cm 5-Fr PDS.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shanxi, China