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

Not Applicable

Completed

• Conditions: Pancreatic Fistula
• Interventions: Procedure: Fistulography and trans-drain occlusion; Procedure: Fistulography

• Registration Number: NCT03800940
• Lead Sponsor: 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.

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 If the patient remains well despite high fistula output, drains are slowly withdrawn in an attempt to decrease the output and close the fistula.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

Study Timeline

• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-08
• Study Start: 2019-01-11
• Study First Posted: 2019-01-11
• Primary Completion: 2022-11-27
• Status Verified: 2023-03
• Study Completion: 2023-03-27
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fistulography and trans-drain occlusion	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.
Fistulography	Fistulography	Fistulography is performed to assess the condition of the fistula, without trains-drain occlusion.

Primary Outcome Measures

Name	Time	Method
Days to fistula closure	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

Name	Time	Method
30-day fistula closure rate	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	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	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	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	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan