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
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Fistula||Procedure: Fistulography and trans-drain occlusion Procedure: Fistulography||Not Applicable|
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 If the patient remains well despite high fistula output, drains are slowly withdrawn in an attempt to decrease the output and close the fistula.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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||57 participants|
|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)|
|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|
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
Sham Comparator: Fistulography
Fistulography is performed to assess the condition of the fistula, without trains-drain occlusion.
Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.
- 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
- 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
- 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.
- 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
- 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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800940
|Contact: Wei-Chih Liao, MD, PhD||886-2-23123456 ext firstname.lastname@example.org|
|Contact: Yu-Wen Tien, MD, PhD||886-2-23123456 ext email@example.com|
|National Taiwan University Hospital||Not yet recruiting|
|Taipei, Taiwan, 100|
|Contact: Wei-Chih Liao, MD, PhD 886-2-23123456 ext 63356 firstname.lastname@example.org|
|Sub-Investigator: Wei-Chih Liao, MD, PhD|
|Principal Investigator:||Yu-Wen Tien, MD, PhD||National Taiwan University Hospital|