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

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Post-ERCP Acute Pancreatitis

Treatments: Device: 7cm 5-Fr PDS; Drug: Indomethacin; Device: 5cm 5-Fr PDS

Study type: Interventional

Funder types: Other

Identifiers

NCT04145336

KY20191010-2

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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800 participants in 2 patient groups

5cm PDS group

Active Comparator group

Description:

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

Treatment:

Device: 5cm 5-Fr PDS

Drug: Indomethacin

7cm PDS group

Experimental group

Description:

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

Treatment:

Drug: Indomethacin

Device: 7cm 5-Fr PDS