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Trans-drain Occlusion for Postoperative Pancreatic Fistula- A Double Blind Randomized Clinical Trial

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ClinicalTrials.gov Identifier: NCT03800940
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
This is a multicenter, investigator initiated, prospective, superiority, parallel-group, randomized, double-blinded trial that aims to compare the efficacy and safety of trans-drain occlusion followed by gradual withdrawal of drain versus gradual withdrawal of drain alone for postoperative pancreatic fistula (POPF) that persists for longer than 21 days.

Condition or disease Intervention/treatment Phase
Pancreatic Fistula Procedure: Fistulography and trans-drain occlusion Procedure: Fistulography Not Applicable

Detailed Description:

The most common major complication after pancreatic resection is postoperative pancreatic fistula (POPF), which is defined as a drain output of any measurable volume of fluid on and after postoperative day 3 with an amylase content > 3 times the upper limit of normal serum level. Gradual withdrawal of surgically placed drains in patients who are clinically stable and tolerate a diet is generally adopted to hasten closure of POPF. For high-output fistulas (> 150-200 mL of amylase-rich fluid per day), patients are initially managed with fasting and enteral or parenteral nutrition. If fistula output decreases substantially with these measures and the patient remains clinically well, drain withdrawal is initiated and oral intake is slowly restarted. If the patient remains well despite high fistula output, drains are slowly withdrawn in an attempt to decrease the output and close the fistula. When the output decrease to less than 10 mL per day, the drains are removed.

However, the current standard practice of gradual drain withdrawal is time consuming. Although clinically stable can be discharged with the drain, the drainage tube often remains in place for a prolonged period, with patient discomfort and increased medical cost. In a pilot study by the investigators, 32.5% (37/114) of POPF patients required drainage for longer than 21 days. Besides, there is also considerable risk of recurrent fluid collection along the drain tube tract after drain removal.

The investigators' experience has shown that trans-drain occlusion of the drain tract achieves fistula closure, enabling immediate removal of the drain. In a pilot study, 20 patients underwent trans-catheter occlusion for POPFs that persisted for more than 3 weeks after placement of drainage tubes. No subjective symptoms or abnormalities in blood tests were noted in 17 patients after the procedure. Three patients had abdominal pain without signs of infection, and the pain spontaneously subsided after conservative treatment. POPF healed immediately after occlusion in all of the 20 patients without recurrence during follow-up. This multicenter, investigator initiated, prospective, superiority, parallel-group, randomized, double-blinded trial aims to compare the efficacy and safety of trans-drain occlusion followed by gradual withdrawal of drain versus gradual withdrawal of drain alone for POPF that persists for longer than 21 days.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Enrolled patients will be randomly assigned in a 2:1 ratio to receive trans-drain occlusion followed by gradual drain withdrawal or gradual drain withdrawal.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trans-drain Occlusion for Postoperative Pancreatic Fistula- A Double Blind Randomized Clinical Trial
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Fistulography and trans-drain occlusion
Fistulography is performed to assess the condition of the fistula, and trans-drain occlusion is performed by injecting glue (NBCA and Lipiodol) through the drain to occlude the tract.
Procedure: Fistulography and trans-drain occlusion
  1. Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.
  2. Trans-drain occlusion: a 0.035-inch guidewire is inserted via the puncture needle. The drain tube is removed, cut at 4 cm proximal to the skin fixation site, and preserved for reinsertion. After inserting a 40cm 5Fr KMP catheter over the guidewire, the guidewire is removed. Afte rinsing the KMP catheter with 3ml 5% glucose water, withdraw the catheter and simultaneously inject glue (33%, 1:2, 0.5ml of NBCA + 1ml Lipiodol) into the catheter until the proximal 5cm of the catheter remains inside the tract. The guidewire is re-inserted through the catheter, and then the original drain tube is re-inserted over the guidewire. The guidewire is removed and the drain is fixed.

Sham Comparator: Fistulography
Fistulography is performed to assess the condition of the fistula, without trains-drain occlusion.
Procedure: Fistulography
Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.




Primary Outcome Measures :
  1. Days to fistula closure [ Time Frame: The date of fistula closure is the date on which the drain is removed after an output of ≦ 10 mL during 48 hours, without recurrence of fistula within the next 3 months ]
    Days from the randomly allocated treatment to fistula closure


Secondary Outcome Measures :
  1. 30-day fistula closure rate [ Time Frame: From enrollment to 4 months after fistula occurrence ]
    Proportion of patients in whom the drain can be removed by 30 days after occurrence of fistula, without recurrence within the next 3 months

  2. Rate of persistent or recurrent POPF after initial drain removal [ Time Frame: From drain removal to 3 months after drain removal or recurrence of fistula, whichever occurs first ]
    Proportion of patients with fluid collection on follow-up CT, which is to be performed at 3 months after removal of drain or when recurrence of fistula is suspected clinically.

  3. Length of hospital stay after the assigned treatment [ Time Frame: From treatment to discharge from the index admission, an average of 2 weeks ]
    Days from the assigned treatment to discharge

  4. Hospital costs after the assigned treatment [ Time Frame: From treatment to discharge from the index admission, an average of 2 weeks ]
    Costs from the assigned treatment to discharge

  5. Rate of fistula-related complications [ Time Frame: From occurrence of fistula to 3 months after drain removal ]
    Proportion of patients who develop fever/infection, ileus, postpancreatectomy hemorrhage from the assigned treatment to end of follow-up.


Other Outcome Measures:
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: From treatment to discharge from the index admission, an average of 2 weeks ]
    Fever/infection or pain that develops within 48 hours after the allocated treatment, or any adverse events judged to be related to the treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who undergo pancreatoduodenectomy (with or without pylorus preservation)
  • With POPF that persists for 3 weeks after occurrence

Exclusion Criteria:

  • Younger than 20 years of age
  • Active infection not adequately controlled [body temperature ≧38.5℃ and/or leukocytosis (WBC count >12,000 /uL) or leukopenia (WBC count <4,000 /uL)]
  • Current or history of severe heart, lung, kidney, or liver failure
  • Karnofsky Performance Score <60
  • Pregnant or lactating
  • Have received somatostatin or its analogue in the index admission
  • Decline to participate

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): NCT03800940


Contacts
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Contact: Wei-Chih Liao, MD, PhD 886-2-23123456 ext 63356 david.ntuh@gmail.com
Contact: Yu-Wen Tien, MD, PhD 886-2-23123456 ext 65330 ywtien5106@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 100
Contact: Wei-Chih Liao, MD, PhD    886-2-23123456 ext 63356    david.ntuh@gmail.com   
Sub-Investigator: Wei-Chih Liao, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Yu-Wen Tien, MD, PhD National Taiwan University Hospital
  Study Documents (Full-Text)

Documents provided by National Taiwan University Hospital:

Publications:

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03800940     History of Changes
Other Study ID Numbers: 201809040RIND
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases