Clinical trial NCT03800940: Trans-drain Occlusion for Postoperative Pancreatic Fistula- A Double Blind Randomized Clinical Trial
Official title: Trans-drain Occlusion for Postoperative Pancreatic Fistula- A Double Blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Fistula
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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 If the patient remains well despite high fistula output, drains are slowly withdrawn in an attempt to decrease the output and close the fistula.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.

Eligibility criteria: Inclusion Criteria:

* Patients who undergo pancreatectomy (including pancreatoduodenectomy with or without pylorus preservation, distal pancreatectomy, and central pancreatectomy) and develop POPF that persists for 3 weeks after its occurrence.
* With POPF that persists for 3 weeks after occurrence

Exclusion Criteria:

* Younger than 20 years of age
* Active infection not adequately controlled \[body temperature ≧38.5℃ and/or eukocytosis (WBC count \>15,000 /uL)/leukopenia (WBC count \<4,000 /uL)\], have residual intra-abdominal fluid collection (largest diameter \> 4cm) despite tube drainage on CT scan (with or without contrast, performed when the patient meet inclusion criteria).
* 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

Primary outcomes:
measure: Days to fistula closure
timeFrame: 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
Secondary outcomes:
measure: 30-day fistula closure rate
timeFrame: From enrollment to 4 months after fistula occurrence
measure: Rate of persistent or recurrent POPF after initial drain removal
timeFrame: From drain removal to 3 months after drain removal or recurrence of fistula, whichever occurs first
measure: Length of hospital stay after the assigned treatment
timeFrame: From treatment to discharge from the index admission, an average of 2 weeks
measure: Hospital costs after the assigned treatment
timeFrame: From treatment to discharge from the index admission, an average of 2 weeks
measure: Rate of fistula-related complications
timeFrame: From occurrence of fistula to 3 months after drain removal
Other outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: From treatment to discharge from the index admission, an average of 2 weeks
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Wen Tien, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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