- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03055676
Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy
April 21, 2020 updated by: Peking Union Medical College Hospital
A Randomized Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
319
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100730
- Peking Union Medical College Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- PD with or without pylorus preserving;
- Age between 18 and 75 years;
- Drain amylase on POD 1 and 3 less than 5000 U/L;
- Drain output within POD 3 less than 300 ml per day.
Exclusion Criteria:
- Vascular reconstruction using an artificial graft;
- Grade B/ C postoperative bleeding, evident anastomosis leakage within 3 days after surgery;
- Refusale to participate in after signed informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Early drain removal
Removing drain(s) on postoperative day 3 (n = 166)
|
Removing drain(s) on postoperative day 3
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ACTIVE_COMPARATOR: Late drain removal
Removing drain(s) on postoperative day 5 or later (n = 166)
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Removing drain(s) on postoperative day 5 or later
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The sum of grade 2- 4 complications
Time Frame: 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.
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Up to postoperative 90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intra-abdominal bleeding
Time Frame: Up to postoperative 90 days
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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.
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Up to postoperative 90 days
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Delayed gastric emptying
Time Frame: Up to postoperative 90 days
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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.
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Up to postoperative 90 days
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Grade B/C complications
Time Frame: Up to postoperative 90 days
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The International Study Group of Pancreatic Surgery (ISGPS) definition
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Up to postoperative 90 days
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Length of hospital stay (day)
Time Frame: Up to postoperative 90 days
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Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
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Up to postoperative 90 days
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Comprehensive complication index (CCI)
Time Frame: Up to postoperative 90 days
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integrates all complications of the Clavien-Dindo classification (CDC) and offers a metric approach to measure morbidity.
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Up to postoperative 90 days
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Interventional treatment
Time Frame: Up to postoperative 90 days
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interventional treatment for any complication.
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Up to postoperative 90 days
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Total medical expenses
Time Frame: Up to postoperative 90 days
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Total medical expenses during hospitalization.
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Up to postoperative 90 days
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Any other single intem of grade 2-4 complication
Time Frame: Up to postoperative 90 days
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Clavein Dindo Classification is adopted.
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Up to postoperative 90 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (ACTUAL)
March 1, 2020
Study Completion (ACTUAL)
April 1, 2020
Study Registration Dates
First Submitted
February 14, 2017
First Submitted That Met QC Criteria
February 14, 2017
First Posted (ACTUAL)
February 16, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 24, 2020
Last Update Submitted That Met QC Criteria
April 21, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- PUMCH-GS05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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