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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2020-10-31

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.

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Detailed Description

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Conditions

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Post-ERCP Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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5cm PDS group

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

Group Type ACTIVE_COMPARATOR

5cm 5-Fr PDS

Intervention Type DEVICE

High-risk patients receive 5cm 5-Fr PDS

Indomethacin

Intervention Type DRUG

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

7cm PDS group

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

Group Type EXPERIMENTAL

7cm 5-Fr PDS

Intervention Type DEVICE

High-risk patients receive 7cm 5-Fr PDS

Indomethacin

Intervention Type DRUG

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

Interventions

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5cm 5-Fr PDS

High-risk patients receive 5cm 5-Fr PDS

Intervention Type DEVICE

7cm 5-Fr PDS

High-risk patients receive 7cm 5-Fr PDS

Intervention Type DEVICE

Indomethacin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No