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

Site(s) and/or Type:  Pancreas

Stage:     

Principal Investigator:  Berger, Adam

Patient Eligibility

Inclusion Criteria:

• Patients must have undergone pancreaticoduodenectomy.
• Must have pancreatic remnant remaining in place (body and tail).
• Must be candidate for reconstruction by pancreaticojejunostomy by one of the two techniques described below.
• Must have an identifiable pancreatic duct which can be used for a duct-to-mucosa anastomosis.

Exclusion Criteria:

• Patients undergoing total pancreatectomy.
• Patients undergoing PD who have had previous left-sided pancreatic resection.
• Failure to sign informed consent.
• Failure to identify the pancreatic duct.
• Pregnant patients.
  
  

Protocol Treatment
There has been only one small randomized, prospective trial evaluating a duct-to-mucosa versus an end-to-side PJ reported in the literature. In this trial, the authors randomized 144 patients undergoing PD to either a 2-layer duct-to-mucosa anastomosis or a single layer end-to-side anastomosis which was not invaginated. Pancreatic fistulas were seen in 14% of patients—13% in the duct-to-mucosa group and 15% in the end-to-side group and there was no difference in complications between groups. It is not entirely clear from this study how these anastomoses were performed, but it does not appear that their construction was compatible to the methods that are most commonly used today.

Therefore, we propose to perform a randomized, prospective, controlled study comparing these two techniques. This study will be offered to all patients at Thomas Jefferson Hospital undergoing PD. Patients will be recruited on the basis of the preoperative anticipation of pancreaticoduodenal resection and preoperative consent will be obtained. Stratification and randomization will be performed intraoperatively, following pancreaticoduodenal resection.

Because many studies have demonstrated that leak rates are directly related to pancreatic texture, we will stratify into two groups: soft (normal) texture (predicted fistula rate of 15-30%) and hard (fibrotic) texture (predicted fistula rate of 0-15%). Patients will be randomized to one of two groups: 1) pancreatic duct to jejunal mucosa, two-layer anastomosis or 2) end-to-side, two-layer, invagination technique.