An interventional study of Fistulography and trans-drain occlusion and Fistulography in Pancreatic Fistula, sponsored by National Taiwan University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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 If the patient remains well despite high fistula output, drains are slowly withdrawn in an attempt to decrease the output and close the fistula.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.
125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's enrollment of 60 is below the median of 110 across 75 interventional studies indexed under Pancreatic Fistula.
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Exclusion Criteria:
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
Fistulography is performed to assess the condition of the fistula, without trains-drain occlusion.
Procedure: Fistulography
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.
Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.
Days to fistula closure
Days from the randomly allocated treatment 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
30-day fistula closure rate
Proportion of patients in whom the drain can be removed by 30 days after occurrence of fistula, without recurrence within the next 3 months
Time frame: From enrollment to 4 months after fistula occurrence
Rate of persistent or recurrent POPF after initial drain removal
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.
Time frame: From drain removal to 3 months after drain removal or recurrence of fistula, whichever occurs first
Length of hospital stay after the assigned treatment
Days from the assigned treatment to discharge
Time frame: From treatment to discharge from the index admission, an average of 2 weeks
Hospital costs after the assigned treatment
Costs from the assigned treatment to discharge
Time frame: From treatment to discharge from the index admission, an average of 2 weeks
Rate of fistula-related complications
Proportion of patients who develop fever/infection, ileus, postpancreatectomy hemorrhage from the assigned treatment to end of follow-up.
Time frame: From occurrence of fistula to 3 months after drain removal
Incidence of Treatment-Emergent Adverse Events
Fever/infection or pain that develops within 48 hours after the allocated treatment, or any adverse events judged to be related to the treatment
Time frame: From treatment to discharge from the index admission, an average of 2 weeks
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National Taiwan University Hospital