Early Pancreatic Duct Stent Removal in Preventing Post-endoscopic Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

Immediate Pancreatic Duct Stent Removal Does Not Prevent Pancreatitis After Accidental Pancreatic Duct Cannulation - A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449084
• Other study ID #: EPDSR
• Status: Completed
• Phase: N/A
• First received: October 4, 2011
• Last updated: October 10, 2011
• Start date: December 2009
• Est. completion date: June 2011

Study information

• Verified date: October 2011
• Source: Nuovo Ospedale Civile S.Agostino Estense
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Procedure:
• immediate stent removal
The stent used was a 5-Fr polyethylene duodenal pigtail pancreatic stent without an inner flange. The stent length was 4 or 5 cm (Zimmon stent, Cook Endoscopy, Winston-Salem, NC, USA): selection was based on the degree of flexion and the length of the Wirsung duct in the head of the pancreas. THE STENT WAS REMOVED AT THE END OF THE ERCP PROCEDURE

Other:
• Leaving the stent in place
The stent used was a 5-Fr polyethylene duodenal pigtail pancreatic stent without an inner flange. The stent length was 4 or 5 cm (Zimmon stent, Cook Endoscopy, Winston-Salem, NC, USA): selection was based on the degree of flexion and the length of the Wirsung duct in the head of the pancreas. THE STENT WAS LEFT IN PLACE AT THE END OF THE ERCP PROCEDURE

Locations

Country	Name	City	State
Italy	Nuovo Ospedale Civile S. Agostino-Estense	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Nuovo Ospedale Civile S.Agostino Estense

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events, i.e. post-endoscopic pancreatitis	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).	24 h	Yes
Secondary	Number of participants with proximal migration of the stent among those patients randomly assigned to leaving the stent in place.	Radiological surveillance at 24-h intervals in order to detect proximal migration of the stent in the main pancreatic duct.	96 hours	Yes