NCT01023594.
| Trial name or title | Comparison of feasibility between internal and external pancreatic drainage in pancreaticoduodenectomy |
| Methods | Allocation: Randomized Endpoint classification: Safety/efficacy study Intervention model: Parallel assignment Masking: Open label Primary purpose: Prevention |
| Participants | People who have malignant or benign disease that needs pancreaticoduodenectomy Participant age: ≥ 20 and ≤ 85 years |
| Interventions | External stent: Active comparator feeding tube insert at pancreaticojejunostomy site as a stent. And stent tube is brought out through jejunal loop below the hepaticojejunostomy site and abdominal wall. Intervention: Procedure: Pancreatic stent Internal stent: Active comparator short (5 cm) internal stent insertion at pancreaticojejunostomy site. Intervention: Procedure: Pancreatic stent |
| Outcomes | Evidence of pancreatic fistula confirmed by serum and drain amylase Pancreatic endocrine and exocrine function by blood test, stool exam |
| Starting date | January 2010 |
| Contact information | Contact: Sun‐Whe Kim, MD 82‐2‐2072‐2310 sunkim@plaza.snu.ac.kr Contact: Jin‐Young Jang, MD 82‐2‐2072‐2194 jangjy4@gmail.com |
| Notes | ClinicalTrials.gov identifier: NCT01023594 Website: http://www.clinicaltrials.gov/ This study is ongoing, but not recruiting participants. Last updated: 14 September 2015 |