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Pancreatic Stent to Prevent Leak After Distal Pancreatectomy (LEAPS)

Mass General Brigham logo

Mass General Brigham

Status

Withdrawn

Conditions

Pancreatic Diseases
Pancreatic Surgery
Distal Pancreatectomy
Pancreatic Cyst
Pancreatic Duct Stenting
Pancreatic Ducts
Pancreatic Cancer

Treatments

Procedure: Pancreatic duct stenting

Study type

Interventional

Funder types

Other

Identifiers

NCT00671463
2007P000965

Details and patient eligibility

About

The purpose of this study is to investigate an intervention to prevent complications after pancreas surgery. The goal is to determine if placing a stent into the pancreatic duct before surgery will decrease or prevent leaking from the pancreatic duct after surgery. Leaks are common after pancreas surgery and can result in serious problems and post-operative pain. The study will compare two groups. One group will have the stent before surgery, and the other group will have standard pancreas surgery, no endoscopy, and no stent.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients (greater than or equal to 18 years of age)
  • Scheduled to undergo an elective laparoscopic or open distal pancreatectomy
  • Willing to undergo pre-operative endoscopy
  • Consenting to the procedure

Exclusion criteria

  • Contraindication to abdominal surgery
  • Contraindication to general anesthesia or distal pancreatectomy
  • Contraindication to upper endoscopy or ERCP
  • Prior history of gastric bypass or other abdominal surgery in whom the ampulla will not be accessible via routine ERCP
  • Ongoing pancreatitis
  • Pancreatic necrosis or abscess
  • History of sphincter of Oddi dysfunction
  • History of ERCP-induced pancreatitis

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

1
Experimental group
Description:
Pre-operative pancreatic duct stenting
Treatment:
Procedure: Pancreatic duct stenting
2
No Intervention group
Description:
Control group, no endoscopy and no stent pre-operatively

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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