PaGaSo – Improvement of anastomosis healing with external negative pressure drain of the pancreatic duct in pancreatogastrostomy following pylorus-preserving pancreaticoduodenectomy

PaGaSo – Improvement of anastomosis healing with external negative pressure drain of the pancreatic duct in pancreatogastrostomy following pylorus-preserving pancreaticoduodenectomy - PaGaSo

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00021634

Enrollment

100

Registered

2021-03-10

Start date

2019-07-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

K86.9 C25.0

Interventions

Group 1: Intervention group -> insertion of a pancreatic suction drain into the pancreatic duct Group 2: Control group -> no insertion of a pancreatic suction drain into the pancreatic duct

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patient with a neoplasm in the area of the pancreatic head with indication for resection in the sense of a partial pancreatoduodenectomy with creation of a pancreatogastrotomy, age > 18 years, Written informed consent

Exclusion criteria

Exclusion criteria: ASA 4/5, liver cirrhosis CHILD B/C, cachexia and weight loss of >/= 10 % of body weight in the last 3 months, pregnant or breastfeeding patient.

Design outcomes

Primary

Measure	Time frame
Postoperative pancreatic fistula rate. Several blood values, including serum lipase, protein and albumin, are examined preoperatively. Drainage fluid volume from peripancreatic Easy Flow and pancreatic duct drainage is measured and checked daily. Serum and pancreatic duct-drainage lipase values are measured on postoperative day 3 and 7. Peripancreatic Easy Flow drain lipase is measured on postoperative day 3, 5 and 7. The measurement is continued every second day if there were signs of persistent leakage until the drainage is removed. To monitor the inflammatory systemic response, leukocytes and C-reactive protein are measured on the first 3 postoperative days and every third day thereafter (6. /9. /12. etc.). The pancreatic duct drain and peripancreatic Easy Flow drain is removed on the 7th postoperative day if there was no evidence of a leakage. However, if there was evidence of leakage or suspected infective complications (fever, leukocytosis and purulent drainage fluid), the peripancreatic drain is left in situ. In addition, patients are asked about nausea and vomiting during daily rounds and the abdominal status is examined. All possible relevant complications such as anastomosis bleeding, insufficiency of the hepaticojejunostomy or the entero-enterostomy, delayed gastric emptying and reoperation are assessed. According to the ISGPS 2016 classification, POPF are classified into 3 groups (5). -Biochemical leak -Grade B -Grade C	—

Measure

Time frame

Postoperative pancreatic fistula rate. Several blood values, including serum lipase, protein and albumin, are examined preoperatively. Drainage fluid volume from peripancreatic Easy Flow and pancreatic duct drainage is measured and checked daily. Serum and pancreatic duct-drainage lipase values are measured on postoperative day 3 and 7. Peripancreatic Easy Flow drain lipase is measured on postoperative day 3, 5 and 7. The measurement is continued every second day if there were signs of persistent leakage until the drainage is removed. To monitor the inflammatory systemic response, leukocytes and C-reactive protein are measured on the first 3 postoperative days and every third day thereafter (6. /9. /12. etc.). The pancreatic duct drain and peripancreatic Easy Flow drain is removed on the 7th postoperative day if there was no evidence of a leakage. However, if there was evidence of leakage or suspected infective complications (fever, leukocytosis and purulent drainage fluid), the peripancreatic drain is left in situ. In addition, patients are asked about nausea and vomiting during daily rounds and the abdominal status is examined. All possible relevant complications such as anastomosis bleeding, insufficiency of the hepaticojejunostomy or the entero-enterostomy, delayed gastric emptying and reoperation are assessed. According to the ISGPS 2016 classification, POPF are classified into 3 groups (5). -Biochemical leak -Grade B -Grade C

—

Secondary

Measure	Time frame
Frequency of occurrence of postoperative pancreatic fistula severity levels (A/B/C)	—

Countries

Germany

Contacts

Public ContactChristian Amling

Department of General, Visceral and Thoracic SurgeryBrandenburg Medical SchoolUniversity Hospital Neuruppin

c.amling@ruppiner-kliniken.de033913947155

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026