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Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03822676
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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Brief Summary:
Postoperative pancreatic fistula (POPF) remains one of the most harmful complications after pancreatic resection. Some studies have indicated that endoscopic pancreatic stenting was effective in the treatment of POPF. However, the results of prospective RCTs for the prophylactic effect of pancreatic stent insertion against POPF were controversial. This single center prospective randomized trial was designed to compare the outcome after segmental pancreatectomy with prophylactic drainage stent versus no stent.

Condition or disease Intervention/treatment Phase
Pancreatic Fistula Device: Prophylactic pancreatic stent Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylactic Pancreatic Stent for the Prevention of Post Operative Pancreatic Fistula Before Segmental Pancreatectomy
Actual Study Start Date : January 22, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arms and Interventions
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Arm Intervention/treatment
Experimental: Stent
Prophylactic pancreatic stent before segmental pancreatic surgery
 Device: Prophylactic pancreatic stent
Prophylactic pancreatic stent before segmental pancreatic surgery
No Intervention: No stent
No prophylactic stent before surgery


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative pancreatic fistula [ Time Frame: from postoperative day 3 to 30 ]
    Grade B and C


Secondary Outcome Measures :
  1. Severity of pancreatic fistula [ Time Frame: from postoperative day 3 to 30 ]
    Grade B POPF requires changes in clinical management, such as persistent drainage, partial or total parenteral nutrition, antibiotics, enteral nutrition, somatostatin analogs, and/or minimal invasive drainage. Grade C POPF requires major changes in management, such as admission to an intensive care unit, reoperation, and/or an extended hospital stay.

  2. Length of stay [ Time Frame: from postoperative day 1 to discharge ]
    Length of hospital stay


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients scheduled for elective segmental pancreatectomy

Exclusion Criteria:

  • Subjects for whom ERCP procedures are contraindicated
  • If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
  • Age less than 18 year
  • Emergency surgery
  • Previous pancreatic surgery
Contacts and Locations
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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): NCT03822676


Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Aiming Yang, M.D.    +86-10-69151593    yangaiming@medmail.com.cn   
Principal Investigator: Yunlu Feng, M.D.         
Sponsors and Collaborators
Peking Union Medical College Hospital
More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03822676    
Other Study ID Numbers: ZS-1833
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Fistula
Fistula
Pathological Conditions, Anatomical
 Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases