Closure of the pancreatic duct after distal pancreatectomy

Closure of the pancreatic duct after distal pancreatectomy - CRP (Closure pancreatic remnant)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32526

Enrollment

250

Registered

2010-01-21

Start date

2011-01-01

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic lesons of the body and tail

Interventions

Conventional closure of the pancreatic remnant After complete mobilisation of the pancreatic body or tail (up to the region of the superior mesenteric vein, or at least 2-3 cm central of the planned

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients undergoing a distal pancreatectomy

Exclusion criteria

Exclusion criteria: Current immunosuppressive or chemotherapy

Design outcomes

Primary

Measure	Time frame
The primary outcome is the development of pancreatic fistula. A pancreatic fistula develops when the closure of the pancreatic remnant fails to heal, causing a leak of pancreas- derived, enzyme-rich fluid from the pancreatic ductal system. A pancreatic fistula is defined as drainage of greater than 50 mL amylase-rich fluid (> 3-fold elevation above upper limit of normal in serum) per day through the drains on or after postoperative day 10. Pancreatic fistulas will be graded according to international fistula definition as published by Strasberg based on the clinical impact on the patient*s hospital course. Grade 1 Deviation from normal postoperative course without pharmacologic, endoscopic, surgical or radiologic intervention (certain drugs allowed) Grade 2 Pharmacologic treatment needed. Includes blood transfusions and total parenteral nutrition Grade 3 (a/b) Surgical, endoscopic or interventional radiologic treatment needed a: Not under general anaesthesia b: Under general anaesthesia Grade 4 (a/b) Life threatening complications and organ dysfunction a: Single organ b: Multi-organ Grade 5 Death due to pancreatic fistula	—

Measure

Time frame

The primary outcome is the development of pancreatic fistula. A pancreatic fistula develops when the closure of the pancreatic remnant fails to heal, causing a leak of pancreas- derived, enzyme-rich fluid from the pancreatic ductal system. A pancreatic fistula is defined as drainage of greater than 50 mL amylase-rich fluid (> 3-fold elevation above upper limit of normal in serum) per day through the drains on or after postoperative day 10. Pancreatic fistulas will be graded according to international fistula definition as published by Strasberg based on the clinical impact on the patient*s hospital course. Grade 1 Deviation from normal postoperative course without pharmacologic, endoscopic, surgical or radiologic intervention (certain drugs allowed) Grade 2 Pharmacologic treatment needed. Includes blood transfusions and total parenteral nutrition Grade 3 (a/b) Surgical, endoscopic or interventional radiologic treatment needed a: Not under general anaesthesia b: Under general anaesthesia Grade 4 (a/b) Life threatening complications and organ dysfunction a: Single organ b: Multi-organ Grade 5 Death due to pancreatic fistula

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Secondary

Measure	Time frame
Secondary endpoints are mortality, morbidity and costs. The mortality rate is defined as the total in-hospital death rate. Postoperative complications, especially delayed gastric emptying, which is defined as a nasogastric tube for more than 10 days after surgery, inability to proceed to a regular diet within 10 days or vomiting for more than 3 consecutive days after the fifth post-operative day. Length of hospital stay Medical costs	—

Measure

Time frame

Secondary endpoints are mortality, morbidity and costs. The mortality rate is defined as the total in-hospital death rate. Postoperative complications, especially delayed gastric emptying, which is defined as a nasogastric tube for more than 10 days after surgery, inability to proceed to a regular diet within 10 days or vomiting for more than 3 consecutive days after the fifth post-operative day. Length of hospital stay Medical costs

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)