Pancreatectomy, Post Procedural Discharge
Conditions
Keywords
Pancreatectomy, Time of drain removal
Brief summary
The aim of this study is to demonstrate the hypothesis that early removal of drain can reduce the incidence of intra-abdominal infection and pancreatic fistula after pancreatectomy compared with later removal of drain.
Detailed description
This study is to analyze the association between the time of removal of drain after pancreatic resection and incidence of intra-abdominal complications, such as intra-abdominal infection and pancreatic leakage. We design a prospective randomized study. Patients with pancreatic and periampullar tumors who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) are recruited to the study if amylase value in drain(s) is less than 5000 U/L on postoperative day (POD) 1. After obtaining informed consent, eligible patients are randomly allocated to early or late drain removal group on POD 3. In the group A, drain(s) are removed on POD 3, whereas in group B drain is removed on POD 4 or beyond. The primary outcomes are the incidence of intra-abdominal infection and pancreatic fistula; the secondary outcomes include intra-abdominal bleeding, delayed gastric emptying, pulmonary complications, and length of hospital stay.
Interventions
OTHEREarly drain removal
Removing drain(s) on postoperative day 3
OTHERLate drain removal
Removing drain(s) on postoperative day 4 or later
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age: \>18yr, \<75yr * Patients with pancreatic diseases (including tumor and inflammatory disease) or non-pancreatic tumors (biliary duct cancer or ampullary tumor) who underwent pancreatoduodenectomy (PD) or distal pancreatectomy (DP) * The amylase value in drain(s) is less than 5000 U/L on postoperative day 1 and 3.
Exclusion criteria
* Reconstruction of the pancreatic remnant by pancreaticogastrostomy * Intra-abdominal hemorrhage within 72 hours after operation * Biliary fistula (output of biliary fluid from at least 1 abdominal drain) within 72 hours after operation * Chylous leakage (milky water) within 72 hours after operation * The volume of drain effluent (ascites) is greater than 300 ml within 72 hours after operation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-abdominal infection | Up to postoperative 30 days | Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test. |
| Pancreatic fistula | Up to postoperative 30 days | The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intra-abdominal bleeding | Up to postoperative 30 days | The International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration. |
| Delayed gastric emptying | Up to postoperative 30 days | The International Study Group of Pancreatic Surgery (ISGPS) definition: Inability to return to a standard diet by the end of the first postoperative week with prolonged nasogastric intubation. |
| Pulmonary complications | Up to postoperative 30 days | Including pulmonary infection and atelectasis. |
| Length of hospital stay (day) | Up to postoperative 2 weeks | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. |
Countries
China
Contacts
Primary ContactMenghua Dai, M.D.
Backup ContactNing Shi, M.D.
Outcome results
None listed