Early Pancreatic Duct Stent Removal in Preventing Post-endoscopic Pancreatitis

Not Applicable

Completed

• Conditions: Acute Pancreatitis
• Interventions: Other: Leaving the stent in place; Procedure: immediate stent removal

• Registration Number: NCT01449084
• Lead Sponsor: Nuovo Ospedale Civile S.Agostino Estense

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.

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-10
• Study First Submitted: 2011-10-04
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-07
• Last Update Submitted: 2011-10-10
• Last Update Posted: 2011-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
leaving the stent in place	Leaving the stent in place	the pancreatic duct stent is left in place
early removal of pancreatic duct stent	immediate stent removal	immediate removal of the pancreatic duct stent at the end of the ERCP procedure

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events, i.e. post-endoscopic pancreatitis	24 h	Post-endoscopic pancreatitis is defined as pancreatic pain and hyperamylasemia within 24 hours of the procedure and is assessed by a physician blinded to group assignment and to radiological surveillance findings. Pancreatic pain is defined as severe and persistent pain in the epigastric or periumbilical region. Hyperamylasemia is defined as an increase in the serum amylase level to greater than 3 times the upper normal limit. The pancreatitis is defined as mild, moderate, or severe according to the criteria proposed by Cotton et al. (GE 1991).

Secondary Outcome Measures

Name	Time	Method
Number of participants with proximal migration of the stent among those patients randomly assigned to leaving the stent in place.	96 hours	Radiological surveillance at 24-h intervals in order to detect proximal migration of the stent in the main pancreatic duct.

Trial Locations

Locations (1)

Nuovo Ospedale Civile S. Agostino-Estense; 🇮🇹 Modena, Italy