Drainage, Pancreaticoduodenectomy
Conditions
Keywords
Pancreaticoduodenectomy, Time of drain removal
Brief summary
The aim of this randomized prospective multicenter study is to demonstrate the hypothesis that early removal of drain could reduce the incidence of major complications (grade 2-4) after pancreaticoduodenectomy (PD) , when compared with later removal of drain.
Detailed description
The objective of this randomized prospective multicenter study is to investigate the association between the time of removal of drain after pancreaticoduodenectomy (PD) and incidence of major complications (grade 2-4 complications). The investigators unite six pancreatic surgery center in Beijing. Patients who underwent pancreaticoduodenectomy (PD) or pylorus-preserving pancreaticoduodenectomy (PPPD) with low to moderate risk of post-operative pancreatic fistula (POPF) are recruited into the study. 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 5 or beyond. The primary outcomes are the incidence of sum of grade 2-4 complications, the secondary outcomes include grade B/C POPF, intra-abdominal infeciton, delayed gastric emptying, post-operative bleeding, in-hospital stay, total medical cost and comprehensive complication index (CCI).
Interventions
OTHEREarly drain removal
Removing drain(s) on postoperative day 3
OTHERLate drain removal
Removing drain(s) on postoperative day 5 or later
Sponsors
Peking University First Hospital
Chinese PLA General Hospital
Xuanwu Hospital, Beijing
Beijing Chao Yang Hospital
Beijing Tongren Hospital
Chinese Academy of Medical Sciences
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
1. PD with or without pylorus preserving; 2. Age between 18 and 75 years; 3. Drain amylase on POD 1 and 3 less than 5000 U/L; 4. Drain output within POD 3 less than 300 ml per day.
Exclusion criteria
1. Vascular reconstruction using an artificial graft; 2. Grade B/ C postoperative bleeding, evident anastomosis leakage within 3 days after surgery; 3. Refusale to participate in after signed informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The sum of grade 2- 4 complications | Up to postoperative 90 days | The severity of complication was measured by Clavein Dindo classifications and grade 2- 4 complications always affect the recovery of the patients significantly.However, the death case (grade 5 complication) is rare now for PD in high volume centers. According to our single center study, early drain removal could reduce the rate of grade 2-4 complications by 12% for the patients undergoing major pancreatectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delayed gastric emptying | Up to postoperative 90 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. |
| Grade B/C complications | Up to postoperative 90 days | The International Study Group of Pancreatic Surgery (ISGPS) definition |
| Length of hospital stay (day) | Up to postoperative 90 days | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. |
| Intra-abdominal bleeding | Up to postoperative 90 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. |
| Interventional treatment | Up to postoperative 90 days | interventional treatment for any complication. |
| Total medical expenses | Up to postoperative 90 days | Total medical expenses during hospitalization. |
| Any other single intem of grade 2-4 complication | Up to postoperative 90 days | Clavein Dindo Classification is adopted. |
| Comprehensive complication index (CCI) | Up to postoperative 90 days | integrates all complications of the Clavien-Dindo classification (CDC) and offers a metric approach to measure morbidity. |
Countries
China
Outcome results
None listed