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Early Pancreatic Duct Stent Removal in Preventing Post-endoscopic Pancreatitis

NCT ID: NCT01449084

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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early removal of pancreatic duct stent

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

Group Type ACTIVE_COMPARATOR

immediate stent removal

Intervention Type 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

the pancreatic duct stent is left in place

Group Type NO_INTERVENTION

Leaving the stent in place

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nuovo Ospedale Civile S.Agostino Estense

OTHER

Sponsor Role lead

Responsible Party

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Rita Conigliaro, MD

Director, Head of Gastroenterology and Endoscopy Unit, NOCSAE

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rita Conigliaro, MD

Role: PRINCIPAL_INVESTIGATOR

Gastroenterologia - NOCSAE - Modena

Locations

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Nuovo Ospedale Civile S. Agostino-Estense

Modena, , Italy

Site Status

Countries

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Italy

Other Identifiers

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EPDSR

Identifier Type: -

Identifier Source: org_study_id