Clinical trial NCT05668260: Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy
Official title: Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy (BioSteP): a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatoduodenectomy
Clinically Relevant Postoperative Pancreatic Fistula
Internal Biodegradable Pancreatic Stent
Keywords: Pancreatic surgery
Pancreatoduodenectomy
CR-POPF
Post operative complications
ARCHIMEDES™
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
Collaborators: name: amg International
First posted: 2022-12-29
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this randomized controlled study is to compare the efficacy of biodegradable internal pancreatic stenting versus no stenting in patients undergoing pancreatoduodenectomy (PD), focusing on a possible superiority association of the device in preventing clinically relevant postoperative pancreatic fistula (CR-POPF).

Patients undergoing PD will be randomized into two arms:

* arm 1: a biodegradable internal pancreatic stent will be placed at the level of the pancreatic anastomosis
* arm 2: no pancreatic stent will be placed at the level of the pancreatic anastomosis

The rate of occurrence of CR-POPF will be compared between the two arms.

Detailed description: Clinically relevant postoperative pancreatic fistula (CR-POPF) represents the most common complication that can occur after pancreatoduodenectomy (PD). CR-POPF is the main cause of morbidity after PD, being associated with a risk of mortality up to 60%. The placement of external or internal pancreatic stents after PD have been investigated as possible strategies for preventing the development of CR-POPF. However, device displacement has been reported as a common cause of pancreatic stents malfunction. Recently, a novel biodegradable pancreatic stent (ARCHIMEDES™) has been introduced. The device has been specifically designed to reduce the risk of displacement, thus offering a new valuable tool to decrease the rate of CR-POPF after PD.

In this randomised, controlled, single-center trial, researchers investigate the possible efficacy of biodegradable internal pancreatic stenting of pancreatic anastomosis in patient undergoing PD versus no stenting, focusing on a possible superiority association for preventing CR-POPF.

Participants will be randomised into two arms (Biodegradable stent vs non-stent) based on their intra-operative risk of developing POPF according to the Fistula Risk Score (FRS). The rate of CR-POPF will be compared between the two arms.

Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Patients who undergo pancreatoduodenectomy (PD)
* Informed Consent

Exclusion Criteria:

* Previous distal pancreatectomy
* Patients with intra-operative negligible, intermediate or moderate risk of POPF (fistula risk score \< 7)

Primary outcomes:
measure: Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF)
timeFrame: from three days after surgery until 3 months after surgery
Secondary outcomes:
measure: Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF) severity
timeFrame: from three days after surgery until 3 months after surgery
measure: Postoperative Morbidity
timeFrame: from the date of surgery, up to 3 months
measure: Length of Hospital Stay (LOS)
timeFrame: from the date of surgery until the date of hospital discharge, assessed up to 3 months
measure: Time to Functional Recovery (TFR)
timeFrame: from the date of surgery until the date of functional recovery, assessed up to 3 months
measure: Quality of Life (QoL)
timeFrame: from the day before surgery until 3 months after surgery
measure: Cost-effectiveness
timeFrame: from the date of surgery, up to 3 months
measure: Stent displacement
timeFrame: 10 days after surgery
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
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