Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00671463

Acronym

LEAPS

Enrollment

Registered

2008-05-05

Start date

2008-04-30

Completion date

Unknown

Last updated

2013-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Pancreas surgery, Pancreatic adenocarcinoma, Pancreatic neuroendocrine tumor, Pancreatic duct stenting

Brief summary

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.

Interventions

PROCEDUREPancreatic duct stenting

In the treatment arm, patients will have a pancreatic duct stent placed prior to having their distal pancreatectomy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Pancreatic leak	Post-operative day 3

Secondary

Measure	Time frame
Peritoneal fluid analysis	Daily
Serum biochemical analysis	Daily
Clinical outcomes	Daily

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026