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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Post-ERCP Acute Pancreatitis

Intervention / Treatment
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* Device: 5cm 5-Fr PDS
* Device: 7cm 5-Fr PDS
* Drug: Indomethacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Un-intentional pancreatic duct cannulation: 2 or more times; 1 time with more than 10 minutes cannulation. Double-wire technique; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5cm PDS group<br>All patients in this group receive 5cm 5-Fr PDS. | Device: 5cm 5-Fr PDS<br>* High-risk patients receive 5cm 5-Fr PDS<br>Drug: Indomethacin<br>* All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.<br>|
| Experimental: 7cm PDS group<br>All patients in this group receive 7cm 5-Fr PDS. | Device: 7cm 5-Fr PDS<br>* High-risk patients receive 7cm 5-Fr PDS<br>Drug: Indomethacin<br>* All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-ERCP Pancreatitis | 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. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate to severe PEP | The severity classification of pancreatitis was defined according to the criteria of Cotton et al and the revised Atlanta criteria. | 14 days | 
| Other complications of ERCP | 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. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, PEP, Post-ERCP pancreatitis, Pancreatic duct stent