Early Pancreatic Duct Stent Removal in Preventing Post-endoscopic Pancreatitis

Nuovo Ospedale Civile S.Agostino Estense

Status: Completed

Conditions: Acute Pancreatitis

Treatments: Procedure: immediate stent removal; Other: Leaving the stent in place

Study type: Interventional

Funder types: Other

Identifiers

NCT01449084

EPDSR

Details and patient eligibility

About

Temporary pancreatic duct stent placement during endoscopic retrograde cholangiopancreatography (ERCP) has been recommended for post-endoscopic pancreatitis (PEP) prophylaxis in high risk patients, including those in whom accidental pancreatic duct cannulation has occurred. However, the optimal duration of stent placement remains an open question. The investigators aim is to assess if immediate stent removal is effective in the prevention of PEP after accidental pancreatic duct cannulation.

Full description

Recent meta-analyses of randomized controlled trials confirmed that pancreatic stent placement after ERCP reduces the risk of PEP but the optimal duration of stent placement remains an open question. It has been suggested that in truly high-risk patients the pancreatic stent must be left in place for a minimum of 24 hours or more whereas in patients at lesser risk pancreatic duct drainage probably only needs to be maintained for a few hours or less. Leaving the stent in place at the end of the ERCP procedure carries the disadvantage of radiological follow-up until spontaneous dislodgment occurs or endoscopic removal is deemed timely; moreover, proximal migration has been reported, requiring endoscopic or even surgical removal. There is a paucity of data comparing immediate removal with spontaneous dislodgment in high-risk patients. In one study, significantly higher rates of PEP were detected in patients in whom a pancreatic stent was removed immediately at the end of the ERCP procedure than in those in whom the stent was left in place: unfortunately, only patients undergoing a precut sphincterotomy were evaluated in that study which was published only in abstract form. Therefore, it is still uncertain whether leaving a stent in place is more effective than immediate removal in preventing PEP in high-risk patients.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients in whom accidental pancreatic duct cannulation had occurred
• during guide wire directed ERCP

Exclusion criteria

• Patients who had undergone previous endoscopic papillectomy or sphincterotomy
• and those with an indwelled nasobiliary or nasopancreatic tube

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

early removal of pancreatic duct stent

Active Comparator group

Description:

immediate removal of the pancreatic duct stent at the end of the ERCP procedure

Treatment:

Procedure: immediate stent removal

leaving the stent in place

No Intervention group

Description:

the pancreatic duct stent is left in place

Treatment:

Other: Leaving the stent in place