Early Pancreatic Duct Stent Removal in Preventing Post-endoscopic Pancreatitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rita Conigliaro, MD, Nuovo Ospedale Civile S.Agostino Estense
ClinicalTrials.gov Identifier:
NCT01449084
First received: October 4, 2011
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Acute Pancreatitis
Procedure: immediate stent removal
Other: Leaving the stent in place

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Immediate Pancreatic Duct Stent Removal Does Not Prevent Pancreatitis After Accidental Pancreatic Duct Cannulation - A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Nuovo Ospedale Civile S.Agostino Estense:

Primary Outcome Measures:
  • Number of participants with adverse events, i.e. post-endoscopic pancreatitis [ Time Frame: 24 h ] [ Designated as safety issue: Yes ]
    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:
  • Number of participants with proximal migration of the stent among those patients randomly assigned to leaving the stent in place. [ Time Frame: 96 hours ] [ Designated as safety issue: Yes ]
    Radiological surveillance at 24-h intervals in order to detect proximal migration of the stent in the main pancreatic duct.


Enrollment: 40
Study Start Date: December 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: early removal of pancreatic duct stent
immediate removal of the pancreatic duct stent at the end of the ERCP procedure
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

No Intervention: leaving the stent in place
the pancreatic duct stent is left in place
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


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01449084

Locations
Italy
Nuovo Ospedale Civile S. Agostino-Estense
Modena, Italy, 41100
Sponsors and Collaborators
Nuovo Ospedale Civile S.Agostino Estense
Investigators
Principal Investigator: Rita Conigliaro, MD Gastroenterologia - NOCSAE - Modena
  More Information

No publications provided

Responsible Party: Rita Conigliaro, MD, Director, Head of Gastroenterology and Endoscopy Unit, NOCSAE, Nuovo Ospedale Civile S.Agostino Estense
ClinicalTrials.gov Identifier: NCT01449084     History of Changes
Other Study ID Numbers: EPDSR
Study First Received: October 4, 2011
Last Updated: October 10, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Nuovo Ospedale Civile S.Agostino Estense:
Pancreatic duct stenting
Post-endoscopic pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 18, 2014