Preoperative Radiotherapy in Patients at High Risk of Postoperative Pancreatic Fistula After Pancreatoduodenectomy

NCT05641233 | Unknown Phase 1

• 1 other identifier: NL72913.018.20
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

The FIBROPANC-1 investigates the feasibility and safety of preoperative stereotactic radiotherapy of 4cm pancreas in patients undergoing pancreatoduodenectomy at high risk (\>25%) of developing post operative pancreatic fistula (POPF). A single course of 12Gy preoperative radiotherapy may lead to sufficient fibrosis in a small (4cm) targeted area, thereby reducing the risk of grade B and C POPF.

Conditions

Neuroendocrine Carcinoma of Pancreas; Duodenum Carcinoma; Pancreas Neoplasm; Distal Cholangiocarcinoma; GIST; Pancreas Fibrosis; Pancreatic Fistula

Keywords

Post operative pancreatic fistula; Stereotactic radiotherapy; Pancreatic fibrosis; Pancreatoduodenectomy

Outcome Measures

Primary Outcomes (2)

• Safety - CTCAE grade 3-4-5 complications related to the intervention

  Up to 30 days after surgery

• Hardness of pancreas texture, determined by Durometer measurement

  Durometric measurement of the radiated and irradiated pancreatic tissue in Shore OO

  Histopathological assesment of tissue after surgery

Secondary Outcomes (8)

• Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C

  Up to 30 days after operation

• Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon

  Assesment during surgery

• Macroscopic tissue assessment, determined by the pathologist

  Histopathological assesment after surgery

• Surgery related postoperative complications defined according to the Clavien-Dindo classification

  Up to 30 days after surgery

• Overall complications

  Up to 30 days after surgery

Study Arms (1)

Intervention arm

EXPERIMENTAL

Radiation: Stereotactic radiotherapy

Interventions

Stereotactic radiotherapy RADIATION

Preoperative radiotherapy delivered in a single fraction of 12 Gy focussed on 4cm pancreas at the intended (i.e. future) anastomotic site.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo pancreatoduodenectomy for another indication than pancreatic ductal adenocarcinoma.
• Pancreatic duct diameter ≤ 3 millimetres, measured on the diagnostic CT scan (at the level of the portomesenteric vein, at the pancreatic neck, the future anastomotic site).
• WHO-ECOG performance status 0,1 or 2.
• Ability to undergo stereotactic radiotherapy and surgery.
• Age ≥ 18 years.
• Good understanding of the oral and written patient information provided.
• Written informed consent.

You may not qualify if:

• Patients undergoing pancreatoduodenectomy for (suspected) pancreatic cancer, chronic pancreatitis, or benign neoplasms (e.g. serous cyst) in the periampullary region.
• Patients with (a history of) chronic pancreatitis

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (2)

Amsterdam UMC

Amsterdam, North Holland, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

RECRUITING

Related Publications (1)

• Suurmeijer JA, Wismans LV, Hendriks TE, Bruynzeel AM, Nuyttens JJ, Intven MPW, van Driel LMJW, Groot Koerkamp B, Busch OR, Stoker JJ, Verheij J, Farina A, Doukas M, de Hingh IHJ, Lips DJ, van der Harst E, van Tienhoven G, Besselink MG, van Eijck CHJ; Dutch Pancreatic Cancer Group. Feasibility, safety and preliminary efficacy of preoperative stereotactic radiotherapy on the future pancreatic neck transection margin to reduce the risk of pancreatic fistula after high-risk pancreatoduodenectomy (FIBROPANC): protocol for a multicentre, single-arm trial. BMJ Open. 2024 Sep 24;14(9):e087193. doi: 10.1136/bmjopen-2024-087193.

  PMID: 39317507 DERIVED

MeSH Terms

Conditions

Duodenal Neoplasms; Pancreatic Neoplasms; Pancreatic Fistula

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Leonoor Wismans

CONTACT

010-703 38 54; l.wismans@erasmusmc.nl

Tessa Hendriks

CONTACT

t.e.hendriks@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. Casper H.J. van Eijck

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 7, 2022
• Study Start: December 1, 2020
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: December 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)