Status:
COMPLETED
Trans-drain Occlusion for Postoperative Pancreatic Fistula- A Double Blind Randomized Clinical Trial
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Pancreatic Fistula
Eligibility:
All Genders
20+ years
Phase:
NA
Brief Summary
This is a multicenter, investigator initiated, prospective, superiority, parallel-group, randomized, double-blinded trial that aims to compare the efficacy and safety of trans-drain occlusion followed...
Detailed Description
The most common major complication after pancreatic resection is postoperative pancreatic fistula (POPF), which is defined as a drain output of any measurable volume of fluid on and after postoperativ...
Eligibility Criteria
Inclusion
- Patients who undergo pancreatectomy (including pancreatoduodenectomy with or without pylorus preservation, distal pancreatectomy, and central pancreatectomy) and develop POPF that persists for 3 weeks after its occurrence.
- With POPF that persists for 3 weeks after occurrence
Exclusion
- Younger than 20 years of age
- Active infection not adequately controlled \[body temperature ≧38.5℃ and/or eukocytosis (WBC count \>15,000 /uL)/leukopenia (WBC count \<4,000 /uL)\], have residual intra-abdominal fluid collection (largest diameter \> 4cm) despite tube drainage on CT scan (with or without contrast, performed when the patient meet inclusion criteria).
- Current or history of severe heart, lung, kidney, or liver failure
- Karnofsky Performance Score \<60
- Pregnant or lactating
- Have received somatostatin or its analogue in the index admission
- Decline to participate
Key Trial Info
Start Date :
January 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03800940
Start Date
January 11 2019
End Date
March 27 2023
Last Update
March 28 2023
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100