A novel radiopaque biodegradable stent for pancreatobiliary applications – The first human phase I trial in the pancreas

Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland.
Pancreatology (Impact Factor: 2.84). 05/2012; 12(3):264-71. DOI: 10.1016/j.pan.2012.02.016
Source: PubMed


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.
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.
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.
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.

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    • "Previously we have shown that after pancreaticoduodenectomy the novel Finnish binding (purse-string) pancreaticojejunal anastomosis (FBPJ) technique reduces the risk for POPF [11]. The aim of this study was to investigate whether FBPJ is a feasible technique after distal pancreatectomy and whether it prevents the risk for POPF after distal pancreatec- tomy. "
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    ABSTRACT: Background: After pancreaticoduodenectomy, the Finnish binding pancreaticojejunal anastomosis (FBPJ) seems to reduce the risk for pancreatic fistula (POPF). Our aim was to investigate whether FBPJ is feasible and prevents the risk for POPF even after left pancreatectomy (LP). Patients and methods: 47 consecutive patients underwent LP. 27 patients were recruited on the basis of CT and, of these, 16 patients were randomized on the basis of findings during surgery (transection line must be left of portal vein, as 2-3 cm pancreatic mobilization is required for FBPJ) to receive either Roux-Y FBPJ or hand-sewn closure of the pancreatic remnant. Results: Only 34% (16/47) of the patients met the randomization criteria. Clinically significant POPF rate was higher in FBPJ group (60%) compared to thand-sewn closure group (13%; P<0.05). POPF rate in FBPJ group was higher even when compared to all patients with hand-sewn closure (60% versus 37%; P<0.05). Overall, FBPJ was technically feasible for only 28% of patients. Conclusion: FBPJ cannot be recommended for the routine closure of the pancreatic remnant after LP, as it was not technically achievable in 72% of the cases. Moreover, the technique does not seem to reduce the risk for POPF compared to the hand-sewn closure.
    BioMed Research International 06/2014; 2014(4):508714. DOI:10.1155/2014/508714 · 2.71 Impact Factor
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    • "Bioabsorbable stent is still in laboratory stages, without clinical use so far.39-42 It is noteworthy that recently a research team in Finland has gained an unparalleled position in this field when they reported the results of a phase 1 clinical study after long and hard work in animal tests.43 "
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    ABSTRACT: Biliary stents are widely used not only for palliative treatment of malignant biliary obstruction but also for benign biliary diseases. Each plastic stent or self-expandable metal stent (SEMS) has its own advantages, and a proper stent should be selected carefully for individual condition. To compensate and overcome several drawbacks of SEMS, functional self-expandable metal stent (FSEMS) has been developed with much progress so far. This article looks into the outcomes and defects of each stent type for benign biliary stricture and describes newly introduced FSEMSs according to their functional categories.
    Clinical Endoscopy 09/2013; 46(5):515-521. DOI:10.5946/ce.2013.46.5.515
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    ABSTRACT: Recent studies have described that binding pancreaticojejunostomy (PJ) decreased the incidence of postoperative pancreatic fistulas and complications after pancreaticoduodenectomy. We herein describe the case of a 77-year-old male with papilla of Vater cancer who underwent subtotal stomach-preserving pancreaticoduodenectomy with end-to-side binding PJ. He developed postoperative gastrointestinal bleeding from the pancreatic cut end three separate times. Transcatheter arterial embolization was performed for the first bleeding event. Surgical hemostasis was performed and a temporary jejunostomy was constructed at the jejunal stump for the second event. For the third bleeding event, endoscopic coagulation through the jejunostomy was performed successfully, and no further bleeding was noted.
    Surgery Today 05/2013; 44(9). DOI:10.1007/s00595-013-0618-1 · 1.53 Impact Factor
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