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PancreatoduodenectomyBioStePNCT05668260

Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy

A study testing Biodegradable Stent in people with Pancreatoduodenectomy and Clinically Relevant Postoperative Pancreatic Fistula, run by Ospedale San Raffaele at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biodegradable Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteItaly
Study dates
25 Jan 2023to 28 Jan 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS Ospedale San Raffaele

    Milan, Milan, 20132

Other trials in Italy

About this study

Official title: Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy (BioSteP): a Randomized Controlled Study

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.

Read the 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.

Being tested
Biodegradable Stent
Keywords
Pancreatic surgery, Pancreatoduodenectomy, CR-POPF, Post operative complications, ARCHIMEDES™

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biodegradable StentDevice

    A trans-anastomotic biodegradable internal stent (ARCHIMEDES™) will be placed between the main pancreatic duct (MPD) and the enterotomy in the jejunum just after the completion of the posterior suture of duct-to-mucosa. The biodegradable stent will then be shaped according to the angle of the jejunal loop in order to minimise the risk of displacement. The adequate length of the stent will be chosen according to the length of the jejunal loop.

Study groups in NCT05668260
Study groupRoleWhat they receive
Biodegradable StentExperimentalAn internal biodegradable pancreatic stent (ArchimedesTM) will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.
Receives: Device: Biodegradable Stent
Non StentNo interventionNo stent will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF)

    The primary objective of the study is to compare the rate of CR-POPF after PD with duct-to-mucosa pancreatico-jejunostomy (PJ) using biodegradable pancreatic internal stent vs no stent.

    Measured: from three days after surgery until 3 months after surgery

Secondary outcomes (7)

  1. Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF) severity

    The difference between the two treatment arms in terms of severity of CR-POPF will be assessed. CR-POPF will be classified according to the ISGPS definition into two groups: grade B and grade C. Grade B will be further sub-classified in three categories according to Maggino et al.: grade B1, grade B2, grade B3.

    Measured: from three days after surgery until 3 months after surgery

  2. Postoperative Morbidity

    The difference between the two treatment arms in terms of rate of overall postoperative morbidity as defined by Dindo et al. will be assessed. Additionally the Comprehensive Complication Index will be calculated. Post-pancreatectomy hemorrhage (PPH) and delayed gastric emptying (DGE) will be defined according to ISGPS definitions.

    Measured: from the date of surgery, up to 3 months

  3. Length of Hospital Stay (LOS)

    The difference between the two treatment arms in terms of median LOS will be assessed. Median LOS will be defined by subtracting the date of surgery from the date when the enrolled patients are discharged from the hospital.

    Measured: from the date of surgery until the date of hospital discharge, assessed up to 3 months

  4. Time to Functional Recovery (TFR)

    The difference between the two treatment arms in terms of time to functional recovery (TFR) will be assessed. TFR will be defined by subtracting the date of surgery from the date when participants achieve standardized criteria (tolerance of oral intake, recovery of lower gastrointestinal function, adequate pain control on oral analgesia, ability to mobilise and self-care and no evidence of untreated medical problems).

    Measured: from the date of surgery until the date of functional recovery, assessed up to 3 months

  5. Quality of Life (QoL)

    The difference between the two treatment arms in terms of QoL will be assessed. QoL will be measured in several ways. First, self-reported activity status will be measured using the Duke Activity Status Index (Duke Index, DASI)., a brief questionnaire designed to assess physical function and predict exercise capacity (peak oxygen uptake). Second, generic health related QoL will be measured using the Patient Reported Outcome Measure Information System (PROMIS)-29+2 Profile v2.1 (PROPr), a questionnaire designed to measure self-reported physical, mental and social health and wellbeing.

    Measured: from the day before surgery until 3 months after surgery

  6. Cost-effectiveness

    The difference between the two treatment arms in terms of cost-effectiveness will be assessed. Cost-effectiveness will be estimated by the ration of differences in costs to differences in quality adjusted life years (QALYs) between the two groups of the study. QALYs will be calculated using the preference scores obtained from PROMIS-29+2. To calculate QALYs, the preference scores at 90 days after surgery will be multiplied by 0.25 (which represents 1/4 of the year). Cost of care will be estimated considering resources consumed during hospital stay and use of healthcare resources after hospital discharge.

    Measured: from the date of surgery, up to 3 months

  7. Stent displacement

    The rate of biodegradable rate displacement as detected by postoperative contrast-enhanced computed tomography (CE-CT) performed by 10 days after surgery. A displacement will be defined by the absence of visible trans-anastomotic stent or by its complete dislocation in the jejunum/ileum or colon.

    Measured: 10 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2022
  2. Study start25 Jan 2023
  3. Primary completion28 Jan 2026
  4. Study completion28 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05668260
Sponsor's protocol ID
BioSteP
Acronym
BioSteP
Status last verified
Jun 2026
First submitted
12 Dec 2022
Last updated
17 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.

    PubMed 23295957

  • Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.

    PubMed 28040257

  • Marchegiani G, Andrianello S, Salvia R, Bassi C. Current Definition of and Controversial Issues Regarding Postoperative Pancreatic Fistulas. Gut Liver. 2019 Mar 15;13(2):149-153. doi: 10.5009/gnl18229.

    PubMed 30419630

  • Partelli S, Andreasi V, Schiavo Lena M, Rancoita PMV, Mazza M, Mele S, Guarneri G, Pecorelli N, Crippa S, Tamburrino D, Doglioni C, Falconi M. The role of acinar content at pancreatic resection margin in the development of postoperative pancreatic fistula and acute pancreatitis after pancreaticoduodenectomy. Surgery. 2021 Oct;170(4):1215-1222. doi: 10.1016/j.surg.2021.03.047. Epub 2021 Apr 28.

    PubMed 33933282

  • Smits FJ, Molenaar IQ, Besselink MG, Borel Rinkes IHM, van Eijck CHJ, Busch OR, van Santvoort HC; Dutch Pancreatic Cancer Group. Early recognition of clinically relevant postoperative pancreatic fistula: a systematic review. HPB (Oxford). 2020 Jan;22(1):1-11. doi: 10.1016/j.hpb.2019.07.005. Epub 2019 Aug 21.

    PubMed 31445782

  • Shrikhande SV, Sivasanker M, Vollmer CM, Friess H, Besselink MG, Fingerhut A, Yeo CJ, Fernandez-delCastillo C, Dervenis C, Halloran C, Gouma DJ, Radenkovic D, Asbun HJ, Neoptolemos JP, Izbicki JR, Lillemoe KD, Conlon KC, Fernandez-Cruz L, Montorsi M, Bockhorn M, Adham M, Charnley R, Carter R, Hackert T, Hartwig W, Miao Y, Sarr M, Bassi C, Buchler MW; International Study Group of Pancreatic Surgery (ISGPS). Pancreatic anastomosis after pancreatoduodenectomy: A position statement by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2017 May;161(5):1221-1234. doi: 10.1016/j.surg.2016.11.021. Epub 2016 Dec 24.

    PubMed 28027816

  • Nahm CB, Connor SJ, Samra JS, Mittal A. Postoperative pancreatic fistula: a review of traditional and emerging concepts. Clin Exp Gastroenterol. 2018 Mar 15;11:105-118. doi: 10.2147/CEG.S120217. eCollection 2018.

    PubMed 29588609

  • Xiong JJ, Altaf K, Mukherjee R, Huang W, Hu WM, Li A, Ke NW, Liu XB. Systematic review and meta-analysis of outcomes after intraoperative pancreatic duct stent placement during pancreaticoduodenectomy. Br J Surg. 2012 Aug;99(8):1050-61. doi: 10.1002/bjs.8788. Epub 2012 May 24.

    PubMed 22622664

  • Dong Z, Xu J, Wang Z, Petrov MS. Stents for the prevention of pancreatic fistula following pancreaticoduodenectomy. Cochrane Database Syst Rev. 2016 May 6;2016(5):CD008914. doi: 10.1002/14651858.CD008914.pub3.

    PubMed 27153248

  • Pessaux P, Sauvanet A, Mariette C, Paye F, Muscari F, Cunha AS, Sastre B, Arnaud JP; Federation de Recherche en Chirurgie (French). External pancreatic duct stent decreases pancreatic fistula rate after pancreaticoduodenectomy: prospective multicenter randomized trial. Ann Surg. 2011 May;253(5):879-85. doi: 10.1097/SLA.0b013e31821219af.

    PubMed 21368658

  • Andrianello S, Marchegiani G, Malleo G, Masini G, Balduzzi A, Paiella S, Esposito A, Landoni L, Casetti L, Tuveri M, Salvia R, Bassi C. Pancreaticojejunostomy With Externalized Stent vs Pancreaticogastrostomy With Externalized Stent for Patients With High-Risk Pancreatic Anastomosis: A Single-Center, Phase 3, Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):313-321. doi: 10.1001/jamasurg.2019.6035.

    PubMed 32101272

  • Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM Jr. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013 Jan;216(1):1-14. doi: 10.1016/j.jamcollsurg.2012.09.002. Epub 2012 Nov 2.

    PubMed 23122535

  • Braga M, Pecorelli N, Ariotti R, Capretti G, Greco M, Balzano G, Castoldi R, Beretta L. Enhanced recovery after surgery pathway in patients undergoing pancreaticoduodenectomy. World J Surg. 2014 Nov;38(11):2960-6. doi: 10.1007/s00268-014-2653-5.

    PubMed 24870390

  • Maggino L, Malleo G, Bassi C, Allegrini V, McMillan MT, Borin A, Chen B, Drebin JA, Ecker BL, Fraker DL, Lee MK, Paiella S, Roses RE, Salvia R, Vollmer CM Jr. Decoding Grade B Pancreatic Fistula: A Clinical and Economical Analysis and Subclassification Proposal. Ann Surg. 2019 Jun;269(6):1146-1153. doi: 10.1097/SLA.0000000000002673.

    PubMed 31082914

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PubMed 15273542

Questions about this trial

What is this clinical trial studying?

A study testing Biodegradable Stent in people with Pancreatoduodenectomy and Clinically Relevant Postoperative Pancreatic Fistula, run by Ospedale San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF) (time frame: from three days after surgery until 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05668260, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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