Pancreatico-jejunostomy with a biodegradable pancreatic stent and without stitches through the pancreas.

Previous experimental studies have shown that multiple puncturing and stitching of the pancreas results in an increased pancreatic injury response. Furthermore, post-operative pancreatitis, which still is a largely under-diagnosed condition, appears to be an important mediator of many post-operative complications after pancreatic head resection. Stenting has been suggested to improve both short-term and long-term outcome after pancreaticojejunostomy. We have recently developed a biodegradable, radiopaque self-expanding stent, which has experimentally been shown suitable for pancreatobiliary applications. In this pilot study we tested the new technique for pancreatico-jejunostomy in 3 patients. In this novel anastomosis technique with a biodegradable stent the pancreatic stump is first sunk into the jejunum and tightened with a purse string in the bowel serosa, without any stitches through the pancreatic tissue, and the patency of the pancreatic duct is secured with a biodegradable stent against the compression of the tightened purse-string. The creation of anastomosis was possible as planned in all 3 patients. They all recovered without complications. The stent was seen in x-ray in all 3 during hospitilization, was found to have disappeared by 1 month in 2 patients, but was still in place at 3 months in 1 patient. The initial experiences described herein encourage progression to a phase I safety study, and later possibly to a phase II randomized trial to test the efficacy of the new method.

RCT Entities:   Population Interventions Outcomes