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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with biochemical leak, postoperative pancreatic fistula grade B or C | Defined by the ISGPS guideline (2016) | Up to 30 days after operation |
| Hardness of pancreas texture, determined intraoperatively by the pancreatic surgeon |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leonoor Wismans | Contact | 010-703 38 54 | l.wismans@erasmusmc.nl | |
| Tessa Hendriks | Contact | t.e.hendriks@amsterdamumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | North Holland | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39317507 | Derived | 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. |
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Texture is scaled as soft/intermediate/hard
| Assesment during surgery |
| Macroscopic tissue assessment, determined by the pathologist | Evalatuation of macropscopic differences between radiated and irradiated pancreatic tissue | 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 |
| Readmission rate | Postoperative period |
| Length of hospital stay | Days | Up to 30 days after surgery |
| 30-day mortality and in-hospital mortality | Up to 30 days after surgery |
| Erasmus Medical Center | Recruiting | Rotterdam | South Holland | Netherlands |
|
| ID | Term |
|---|---|
| D004379 | Duodenal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D016154 | Digestive System Fistula |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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