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Early Versus Late Drain Removal After Pancreatectomy: A Randomized Prospective Trial

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ClinicalTrials.gov Identifier: NCT02230436
Recruitment Status : Unknown
Verified August 2016 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
First Posted : September 3, 2014
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreatectomy Post Procedural Discharge Other: Early drain removal Other: Late drain removal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Early Versus Late Drain Removal on Postoperative Morbidity After Pancreatectomy: A Randomized Prospective Trial
Study Start Date : July 2014
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Early drain removal
Removing drain(s) on postoperative day 3 (n = 72)
Other: Early drain removal
Removing drain(s) on postoperative day 3

Experimental: Late drain removal
Removing drain(s) on postoperative day 4 or later (n = 72)
Other: Late drain removal
Removing drain(s) on postoperative day 4 or later




Primary Outcome Measures :
  1. Intra-abdominal infection [ Time Frame: 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.

  2. Pancreatic fistula [ Time Frame: 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 Outcome Measures :
  1. Intra-abdominal bleeding [ Time Frame: 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.

  2. Delayed gastric emptying [ Time Frame: 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.

  3. Pulmonary complications [ Time Frame: Up to postoperative 30 days ]
    Including pulmonary infection and atelectasis.

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



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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:

  • 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.

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): NCT02230436


Contacts
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Contact: Menghua Dai, M.D. daim66@126.com
Contact: Ning Shi, M.D. 8613693303585 shining_doc@163.com

Locations
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China
Peking Union Medical College Hospital Recruiting
Beijing, China, 100730
Contact: Menghua Dai, M.D.       daim66@126.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Chair: Menghua Dai, M.D. Peking Union Medical College Hospital