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Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial


N/A
18 Years
N/A
Not Enrolling
Both
Pancreatic Surgery, Pancreatic Duct Stenting, Pancreatic Cancer, Distal Pancreatectomy, Pancreatic Diseases, Pancreatic Cyst, Pancreatic Ducts

Thank you

Trial Information

Leak Elimination After Pancreatic Stenting, a Randomized Controlled Trial


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Pancreatic leak

Outcome Time Frame:

Post-operative day 3

Safety Issue:

No

Principal Investigator

Field F Willingham, MD, MPH

Investigator Role:

Study Director

Investigator Affiliation:

MGH

Authority:

United States: Institutional Review Board

Study ID:

2007P000965

NCT ID:

NCT00671463

Start Date:

April 2008

Completion Date:

Related Keywords:

  • Pancreatic Surgery
  • Pancreatic Duct Stenting
  • Pancreatic Cancer
  • Distal Pancreatectomy
  • Pancreatic Diseases
  • Pancreatic Cyst
  • Pancreatic Ducts
  • Pancreas surgery
  • Pancreatic adenocarcinoma
  • Pancreatic neuroendocrine tumor
  • Pancreatic duct stenting
  • Pancreatic Cyst
  • Pancreatic Diseases
  • Pancreatic Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617