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Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055676
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : April 24, 2020
Sponsor:
Collaborators:
Peking University First Hospital
Chinese PLA General Hospital
Xuanwu Hospital, Beijing
Beijing Chao Yang Hospital
Beijing Tongren Hospital
Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreaticoduodenectomy Drainage Other: Early drain removal Other: Late drain removal Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 319 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Prospective Multicenter Trial of Early Versus Late Drain Removal After Pancreaticoduodenectomy
Study Start Date : January 2017
Actual Primary Completion Date : March 2020
Actual Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: Early drain removal
Removing drain(s) on postoperative day 3 (n = 166)
Other: Early drain removal
Removing drain(s) on postoperative day 3

Active Comparator: Late drain removal
Removing drain(s) on postoperative day 5 or later (n = 166)
Other: Late drain removal
Removing drain(s) on postoperative day 5 or later




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Intra-abdominal bleeding [ Time Frame: 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.

  2. Delayed gastric emptying [ Time Frame: 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.

  3. Grade B/C complications [ Time Frame: Up to postoperative 90 days ]
    The International Study Group of Pancreatic Surgery (ISGPS) definition

  4. Length of hospital stay (day) [ Time Frame: Up to postoperative 90 days ]
    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

  5. Comprehensive complication index (CCI) [ Time Frame: Up to postoperative 90 days ]
    integrates all complications of the Clavien-Dindo classification (CDC) and offers a metric approach to measure morbidity.

  6. Interventional treatment [ Time Frame: Up to postoperative 90 days ]
    interventional treatment for any complication.

  7. Total medical expenses [ Time Frame: Up to postoperative 90 days ]
    Total medical expenses during hospitalization.

  8. Any other single intem of grade 2-4 complication [ Time Frame: Up to postoperative 90 days ]
    Clavein Dindo Classification is adopted.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055676


Locations
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China
Peking Union Medical College Hospital
Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College Hospital
Peking University First Hospital
Chinese PLA General Hospital
Xuanwu Hospital, Beijing
Beijing Chao Yang Hospital
Beijing Tongren Hospital
Chinese Academy of Medical Sciences
Investigators
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Study Chair: Menghua Dai, M.D. Peking Union Medical College Hospital
Publications:

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03055676    
Other Study ID Numbers: PUMCH-GS05
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by Peking Union Medical College Hospital:
Pancreaticoduodenectomy
Time of drain removal