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WithdrawnNCT00671463LEAPSUpdated Jun 11, 2013

Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

An interventional study of Pancreatic duct stenting in Pancreatic Surgery, Pancreatic Duct Stenting and Pancreatic Cancer, sponsored by Massachusetts General Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-11.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Anticipated high risk of pancreatitis
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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
03

In context

Pancreatic Cyst

94 studies on the registry are indexed under Pancreatic Cyst; 34 are open to participants now.

Browse Pancreatic Cyst studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

    Pre-operative pancreatic duct stenting

    Procedure: Pancreatic duct stenting

  • No intervention
    2

    Control group, no endoscopy and no stent pre-operatively

Interventions

  • ProcedurePancreatic duct stenting

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

06

What researchers measure

Primary outcomes

  1. Pancreatic leak

    Time frame: Post-operative day 3

Secondary outcomes

  1. Peritoneal fluid analysis

    Time frame: Daily

  2. Serum biochemical analysis

    Time frame: Daily

  3. Clinical outcomes

    Time frame: Daily

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00671463
Lead sponsor
Massachusetts General Hospital
Collaborators
American Society for Gastrointestinal Endoscopy
Responsible party
William R. Brugge, MD (Director of Gastrointestinal Endoscopy, Massachusetts General Hospital) — Principal investigator
First posted
May 5, 2008
Start date
Apr 2008
Primary completion
Apr 2010 (estimated)
Last update
Jun 11, 2013

Study contacts

Field F Willingham, MD, MPH
study director · MGH
Denise W Gee, MD
study director · MGH
Sevdenur Cizginer, MD
study director · MGH
David W Rattner, MD
principal investigator · MGH
William R Brugge, MD
principal investigator · MGH

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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