This phase III trial compares two types of surgery, minimally invasive pancreaticoduodenectomy and traditional open pancreaticoduodenectomy, for the treatment of periampullary or pancreatic tumors. Pancreaticoduodenectomy or Whipple procedure involved the removal of the head of the pancreas and surrounding structures. Open (large incision) pancreaticoduodenectomy is the traditional type of surgery and involves making a long incision in the center of the abdomen from the bottom of the breast bone to the belly button. Minimally invasive pancreaticoduodenectomy uses multiple incisions through which a camera and surgical instruments are inserted. Undergoing minimally invasive pancreaticoduodenectomy may work better in treating resectable periampullary or pancreatic tumor compared to traditional open pancreaticoduodenectomy.
Additional locations may be listed on ClinicalTrials.gov for NCT04171440.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Determine the time to functional recovery (days).
SECONDARY OBJECTIVES:
I. Determine the rates and types of complications.
II. Determine whether there is a difference in length of stay between the groups.
III. Determine whether there is a difference in pancreaticoduodenectomy specific complications between the groups.
IV. Determine whether there is a difference in pathologic outcomes between the groups.
V. Determine whether there is a difference in the quality of life measures between the groups.
EXPLORATORY OBJECTIVE:
I. Comprehensive complication index (CCI) is a newly developed index calculated using post-operative complication information.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo traditional open (large incision) pancreaticoduodenectomy.
GROUP II: Patients undergo minimally invasive pancreaticoduodenectomy.
After completion of study treatment, patients are followed up for 30 days.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorJin He
