A Phase 2 interventional study of Stereotactic radiotherapy / pancreaticoduodenectomy in Pancreatic Fistula and Pancreaticoduodenectomy, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Other
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Design of the study Prospective, single arm, multicentric, phase II open trial Number of participating sites 14 French centers of HPB Surgery departments associated with 14 Radiation Oncology Departments.
Implementation of the study A screening of eligible patients will be made locally by the referring surgeon of each centre based on patient medical records.
W9 ( +/- 1W) (V4): post-radiotherapy follow-up
- Preoperative visit Day-1 before PD (V5)
W10 (+/- 1W) (V6):
122 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's planned enrollment of 50 is below the median of 110 across 77 interventional studies indexed under Pancreatic Fistula.
Browse Pancreatic Fistula studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All patients enrolled in the trial and responding to inclusion/exclusion criteria will receive A dose of 20 Gy delivered in 2 fractions of 10 Gy, 1 day apart, of preoperative stereotactic radiotherapy targeting the isthmus of the pancreas over a 4 cm area that corresponds to the future anastomosis zone
Other: Stereotactic radiotherapy / pancreaticoduodenectomy
A dose of 20 Gy delivered in 2 fractions of 10 Gy, 1 day apart, of preoperative stereotactic radiotherapy Surgery : pancreaticoduodenectomy
Number of patients at W22 (within 90 days from surgery) without grade B/C postoperative pancreatic fistula (POPF)
Postoperative fistula grade B and C is defined according to the last ISGPS classification of 2016 and will be adjudicated by independant experts.
Time frame: Week 22
To assess overall surgical complication rate at W22 (90 days after surgery)
defined as a grade 1 to 5 according to the Dindo-Clavien classification complications occurring within 3 month from surgery
Time frame: Week 22
To assess severe surgical complication rate at W22 (90 days after surgery)
defined as a grade 3 to 5 according to the Dindo-Clavien classification complications occurring within 3 month from surgery
Time frame: Week 22
To assess, during surgery (W10), the hardness of pancreas texture on the specimen after resection with a durometer
determined intraoperatively by Durometer measurement of the radiated and irradiated pancreatic tissue in Shore OO
Time frame: Week 10
To assess, during surgery (W10), the hardness of pancreas texture on the specimen after resection by the surgeon
Determined intraoperatively by the pancreatic surgeon. Texture is scaled as soft/intermediate/hard at W10
Time frame: Week 10
To assess, during surgery (W10), technical difficulties added by radiotherapy, according to the surgeon
Determined by 2 questions * To what extent was the surgery complicated by the radiotherapy? (Answers: 1 - not complicated; 2 - slightly complicated; 3 - clearly complicated; 4 - severely complicated; 5 - impossible) * Did you have to adapt the surgical plan due to the administration of radiotherapy? (Answers: Yes/No)
Time frame: Day of surgery- Week 10
To assess on a pathological point of view the resected specimen at W14
determined by the pathologist by evaluation of macroscopic differences between radiated and irradiated pancreatic tissue. \- The extent and distribution of fibrosis and fat infiltration were evaluated using the score established by Rebours et al. in intra- and extralobular locations
Time frame: Day of surgery-week 14
To assess on a pathological point of view the resected specimen at W14
determined by the pathologist by evaluation of macroscopic differences between radiated and irradiated pancreatic tissue. \- Fibrosis quantification was also assessed by determining the area of collagen using Sirius red staining (as performed in FIBROPANC trial)
Time frame: Day of surgery-week 14
Pancreatic functionnal outcomes at W22 (de novo diabetes)
Determined by \- De novo diabetes : In accordance with French and European recommendations, diabetes is diagnosed if fasting blood glucose is greater than or equal to 1.26 g/L on two occasions, or greater than or equal to 2 g/L at any time of the day, or if HbA1c is greater than 6.5%
Time frame: Week 22
Pancreatic functionnal outcomes at W22 (exocrine pancreatic insufficiency)
Determined by \- Exocrine pancreatic insufficiency: A fecal elastase level \< 100 mg/g stool is commonly accepted for diagnosing severe exocrine pancreatic insufficiency, a fecal elastase level between 100 and 200 mg/g indicates moderate exocrine pancreatic insufficiency, and a level \> 200 mg/g stool rules out exocrine pancreatic insufficiency
Time frame: Week 22
To assess mortality rate at W22
Time frame: Week 22
To assess overall length of hospital stay after surgery
Length of hospital stay between the operation and the day of discharge from hospital
Time frame: Up to Week 34
To assess readmission rate at W22
Proportion of readmission at W22, whatever the cause
Time frame: Week 22
To assess radiation-induced complications rate, overall and by grade at W9, W10, W14, W22, W34
to CTCAE classification (Common Terminology Criteria for Adverse Events), overall and by grade (grade 1 to 5)
Time frame: Week 9, Week 10, Week 14, Week 22 and Week 34
To assess safety of radiotherapy at W9, and W34
Proportion of patients at W9 and W34 who underwent at least one side effects of radiotherapy among gastritis or gastric bleeding
Time frame: Week 9 and Week 34
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Aug 2027, 18 months later.
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