Early Pancreatic Duct Stent Removal in Preventing Post-endoscopic Pancreatitis

NCT01449084 | Completed

• 1 other identifier: EPDSR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pancreatitis

Keywords

Pancreatic duct stenting; Post-endoscopic pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of participants with proximal migration of the stent among those patients randomly assigned to leaving the stent in place.

  96 hours

Study Arms (2)

early removal of pancreatic duct stent

ACTIVE COMPARATOR

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

Procedure: immediate stent removal

leaving the stent in place

NO INTERVENTION

the pancreatic duct stent is left in place

Other: Leaving the stent in place

Interventions

immediate stent removal PROCEDURE

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

early removal of pancreatic duct stent

Leaving the stent in place OTHER

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

leaving the stent in place

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nuovo Ospedale Civile S.Agostino Estense: lead

Study Sites (1)

Nuovo Ospedale Civile S. Agostino-Estense

Modena, 41100, Italy

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Rita Conigliaro, MD

  Gastroenterologia - NOCSAE - Modena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Gastroenterology and Endoscopy Unit, NOCSAE

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 7, 2011
• Study Start: December 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

IT (1)