A preventive effect of pancreatic duct stenting to decrease the rate of pancreatic fistula after pancreaticojejunostomy following pancreatoduodenectomy
- Conditions
- pancreatoduodenectomy for pancreatic head cancer, bile duct cancer, cancer of the Vater's papilla, gallbladder cancer, pancreatic head tumor (Intraductal papillary-mucinous neoplasm, endocrine tumor, other pancreatic tumor), chronic pancreatitis
- Registration Number
- JPRN-UMIN000000952
- Lead Sponsor
- Department of surgery, Tohoku University
- Brief Summary
The rate of clinically relevant POPF was significantly lower in the stented group than in the non-stented group: three of 47 (6 per cent) versus ten of 46 (22 per cent) (P = 0.040). Among patients with a dilated duct, rates of POPF were similar in both groups. Among patients with a non-dilated duct, clinically relevant POPF was significantly less common in the stented group than the non-stented group: two of 21 (10 per cent) versus eight of 20 (40 per cent) (P = 0.033). Univariable analysis identified body mass index (BMI), pancreatic cancer, pancreatic texture, pancreatic duct size and duct stenting as risk factors related to clinically relevant POPF. Multivariable analysis taking these five factors into account identified high BMI (risk ratio (RR) 11.4; P = 0.009), non-dilated duct (RR 5.33; P = 0.047) and no stent (RR 10.4; P = 0.004) as significant risk factors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
1)requiring total pancreatectomy 2)unfeasible for pancreaticojejunostomy 3)past history for pancreatectomy 4)other unfeasible factors to study safety, approved attending surgeon 5)pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate and severity of pancreatic fistula
- Secondary Outcome Measures
Name Time Method postoperative morbidity rate, postoperative hospital stay, hospital mortality rate