Pancreatic Stent to Prevent Leak After Distal Pancreatectomy

Massachusetts General Hospital

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

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

Interventions

Pancreatic duct stentingPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Pancreatic leak

Time frame: Post-operative day 3

Secondary Outcomes

Peritoneal fluid analysis

Time frame: Daily

Serum biochemical analysis

Time frame: Daily

Clinical outcomes

Time frame: Daily

Data from ClinicalTrials.gov

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