Clinical Trial: A Randomized Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized Trial of Two Surgical Techniques for Pancreaticojejunostomy in Patients Undergoing Pancreaticoduodenectomy

Brief Summary: The purpose of this trial is to determine whether a mucosa-to-mucosa technique of pancreaticojejunostomy will improve the pancreatic fistula rate.

Detailed Summary:

Pancreaticoduodenectomy (PD) is a commonly performed operative procedure which is used in selected patients with benign and malignant diseases of the pancreas and periampullary region. The procedure involves regional resection of the pancreatic head, neck, and uncinate process en-bloc with the duodenum, distal bile duct, and lymph nodes. The standard 'Whipple' operation also adds a distal gastrectomy to the above procedures, while a pylorus-preserving pancreaticoduodenectomy (PPPD) spares the distal stomach. The indications for PD include neoplastic processes confined to the periampullary region, such as pancreatic cancer, distal common bile duct cancer, duodenal cancer, ampullary cancer, neuroendocrine tumors, cystic tumors, etc. A small number of benign conditions, such as chronic pancreatitis and benign neoplasms are also treated with PD. Upon completion of the pancreatic resection, 3 anastomoses are used to re-establish GI continuity—a pancreatic-enteric anastomosis, a biliary-enteric anastomosis, and a gastro or duodeno-enteric anastomosis. The pancreatic-enteric anastomosis has traditionally been the most troubling of these anastomoses because of a failure to heal and resultant fistulas and leaks.

The operative mortality rate for PD is usually less than 5% in major surgical centers with significant experience with the procedure. The leading causes of mortality include hemorrhage, cardiac events, and sepsis (often related to a pancreatic-enteric fistula). In contrast to this low mortality rate, the morbidity rate is still quite high with one review showing a rate of 40%. One of the most common causes of morbidity is a leak or pancreatic fistula from the pancreatic-enteric anastomosis. A recent review estimated the incidence of this complication to be 10% to 28.5%. A pancreatic fistula is currently defined by the International Study Group for Pancreatic Fistulas
Sponsor: Thomas Jefferson University

Current Primary Outcome: The primary endpoint will be the pancreatic fistula rate.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • length of hospitalization
  • percutaneous intervention rates
  • reoperation rates
  • morbidity
  • death


Original Secondary Outcome: Same as current

Information By: Thomas Jefferson University

Dates:
Date Received: August 1, 2006
Date Started: July 2006
Date Completion: December 2015
Last Updated: March 17, 2015
Last Verified: March 2015