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Completed

NCT Number: NCT01449084

Early Pancreatic Duct Stent Removal in Preventing Post-endoscopic Pancreatitis

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.

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nuovo Ospedale Civile S. Agostino-Estense

Modena, 41100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Number of participants with adverse events, i.e. post-endoscopic pancreatitis

    Time frame: 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 outcomes

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

    Time frame: 96 hours

    Radiological surveillance at 24-h intervals in order to detect proximal migration of the stent in the main pancreatic duct.

Sponsors and collaborators

Lead sponsor

Nuovo Ospedale Civile S.Agostino Estense

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 7, 2011
Registry last updated
Oct 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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