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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Chinese PLA General Hospital | OTHER |
| Xuanwu Hospital, Beijing | OTHER |
| Beijing Chao Yang Hospital |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early drain removal | Experimental | Removing drain(s) on postoperative day 3 (n = 166) |
|
| Late drain removal | Active Comparator | Removing drain(s) on postoperative day 5 or later (n = 166) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early drain removal | Other | Removing drain(s) on postoperative day 3 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The sum of grade 2- 4 complications | 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. | Up to postoperative 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intra-abdominal bleeding | 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. | Up to postoperative 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Menghua Dai, M.D. | Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24374513 | Background | Van Buren G 2nd, Bloomston M, Hughes SJ, Winter J, Behrman SW, Zyromski NJ, Vollmer C, Velanovich V, Riall T, Muscarella P, Trevino J, Nakeeb A, Schmidt CM, Behrns K, Ellison EC, Barakat O, Perry KA, Drebin J, House M, Abdel-Misih S, Silberfein EJ, Goldin S, Brown K, Mohammed S, Hodges SE, McElhany A, Issazadeh M, Jo E, Mo Q, Fisher WE. A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage. Ann Surg. 2014 Apr;259(4):605-12. doi: 10.1097/SLA.0000000000000460. | |
| 16794381 |
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After this multicenter randomized clinical trail complete, the results of this study will be submitted to and published in a peer-reviewing journal. Other researchers can assess our article through electronic database, such as Medline/PubMed.
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| OTHER |
| Beijing Tongren Hospital | OTHER |
| Chinese Academy of Medical Sciences | OTHER |
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| Late drain removal |
| Other |
Removing drain(s) on postoperative day 5 or later |
|
| Delayed gastric emptying | 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. | Up to postoperative 90 days |
| Grade B/C complications | The International Study Group of Pancreatic Surgery (ISGPS) definition | Up to postoperative 90 days |
| Length of hospital stay (day) | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks. | Up to postoperative 90 days |
| Comprehensive complication index (CCI) | integrates all complications of the Clavien-Dindo classification (CDC) and offers a metric approach to measure morbidity. | Up to postoperative 90 days |
| Interventional treatment | interventional treatment for any complication. | Up to postoperative 90 days |
| Total medical expenses | Total medical expenses during hospitalization. | Up to postoperative 90 days |
| Any other single intem of grade 2-4 complication | Clavein Dindo Classification is adopted. | Up to postoperative 90 days |
| Background |
| Kawai M, Tani M, Terasawa H, Ina S, Hirono S, Nishioka R, Miyazawa M, Uchiyama K, Yamaue H. Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg. 2006 Jul;244(1):1-7. doi: 10.1097/01.sla.0000218077.14035.a6. |
| 20622661 | Background | Bassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, Talamini G, Pederzoli P. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010 Aug;252(2):207-14. doi: 10.1097/SLA.0b013e3181e61e88. |
| 17981197 | Background | Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Buchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007 Nov;142(5):761-8. doi: 10.1016/j.surg.2007.05.005. |
| 16003309 | Background | Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001. |
| 17629996 | Background | Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Yeo CJ, Buchler MW. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007 Jul;142(1):20-5. doi: 10.1016/j.surg.2007.02.001. |
| 34117153 | Derived | Dai M, Liu Q, Xing C, Tian X, Cao F, Tang W, Lv S, Ma Y, Zhang D, Kleeff J, Yang Y, Liu R, He Q, Li F, Li G, Guo J, Liao Q, Zhao Y. Early Drain Removal is Safe in Patients With Low or Intermediate Risk of Pancreatic Fistula After Pancreaticoduodenectomy: A Multicenter, Randomized Controlled Trial. Ann Surg. 2022 Feb 1;275(2):e307-e314. doi: 10.1097/SLA.0000000000004992. |