Clinical trial NCT01449084: Early Pancreatic Duct Stent Removal in Preventing Post-endoscopic Pancreatitis
Official title: Immediate Pancreatic Duct Stent Removal Does Not Prevent Pancreatitis After Accidental Pancreatic Duct Cannulation - A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pancreatitis
Keywords: Pancreatic duct stenting
Post-endoscopic pancreatitis
Lead sponsor: Nuovo Ospedale Civile S.Agostino Estense
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events, i.e. post-endoscopic pancreatitis
timeFrame: 24 h
Secondary outcomes:
measure: Number of participants with proximal migration of the stent among those patients randomly assigned to leaving the stent in place.
timeFrame: 96 hours
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Nuovo Ospedale Civile S. Agostino-Estense
Study officials:
affiliation: Gastroenterologia - NOCSAE - Modena
name: Rita Conigliaro, MD
role: PRINCIPAL_INVESTIGATOR
References: