A novel radiopaque biodegradable stent for pancreatobiliary applications--the first human phase I trial in the pancreas.
OBJECTIVE
During the recent years we have developed and experimentally tested a biodegradable stent for pancreatobiliary applications. Such stents may be used in benign strictures or when securing the flow of bile, pancreatic juice or a fluid collection after endoscopic or surgical procedures. The lack of suitable devices has so far prohibited clinical endoscopic or percutaneous tests whereas surgical application has become possible. Recently we described a modified binding (purse string) pancreaticojejunostomy, where a biodegradable stent is introduced to secure the lumen opening when tightening the bowel over the pancreas with a purse string. Although routine use of any stent in pancreaticojejunostomy has been under debate, we used this setting to run for the first phase I human clinical trial with a biodegradable stent in a pancreatobiliary application.


METHODS
After 29 pancreaticoduodenectomies, a braided gamma sterilized radiopaque 96L/4D polylactide stent was introduced into the duct of pancreas remnant, which was then sunk into the Roux-Y jejunal limb. Complications, stent disappearance and late anastomotic patency (MRI) were monitored.


RESULTS
Hospital mortality was zero. One patient developed Grade C fistula (overall fistula rate 3%). She also developed Grade C hemorrhage and Grade C delayed gastric emptying (DGE). One other patient developed Grade B hemorrhage (overall hemorrhage rate 7%) and B DGE. Three other patients developed clinically significant Grade B-C DGE (5/29=17%). In addition, 10 other patients were not on solid food only on post-operative day 8, and were classified as Grade A DGE (34%). Most of these patients were eating normally and could be discharged from hospital by day 10. Nine out of 26 patients (35%) with negative preoperative trypsinogen test, developed post-operative trypsinogen release suggesting pancreatitis. Within 12 months four patients died and one quitted the study. The stents disappeared in median 3 months. MRI interpretation of the anastomosis failed in one patient having ascites. Of the 23 patients, 13 (57%) had the anastomosis well open, three (13%) had some narrowing, while seven (30%) had the anastomosis obstructed.


CONCLUSIONS
Compared with our previous experiences obtained in pancreaticoduodenectomy, a biodegradable stent is well tolerated in the human pancreatic duct, encouraging further development for future applications and tests in randomized trials.
Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland.
Isto
I
Nordback
Sari
S
Räty
Johanna
J
Laukkarinen
Satu
S
Järvinen
Anneli
A
Piironen
Jenni
J
Leppiniemi
Minna
M
Kellomäki
Juhani
J
Sand
D020341:Absorbable Implants; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005746:Gastric Emptying; D006801:Humans; D008297:Male; D008875:Middle Aged; D016577:Pancreaticoduodenectomy / Q000009:adverse effects / Q000379:methods*; D010193:Pancreaticojejunostomy; D011091:Polyesters; D015607:Stents
D011091:Polyesters; C033616:poly(lactide)