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The aim of this prospective, randomized, blinded clinical superiority trial is to establish intraoperative placement of biodegradable stents in the pancreatojejunostomy as a safe, effective, and feasible preventive measure against pancreatic fistula following pancreatoduodenectomy.
The investigators hypothesize that intraoperative placement of biodegradable stents in the pancreatojejunostomy is safe and can reduce the risk of pancreatic leakage following pancreatoduodenectomy in patients who have not undergone PBD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stent | Active Comparator | Placement of biodegradable stent intraoperatively. |
|
| No stent | No Intervention | Control group. No placement of stent. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fast Degradable, Biodegradable ARCHEMEDES stent | Procedure | Fast Degradable, Biodegradable ARCHEMEDES stent. Placed in the pancreaticojejunostomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| POPF | Number of participants with a Postoperative pancreatic fistula | 30 days |
| Number of participants with a Biliary fistula | Postoperative biliary fistula | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Complications to stent placement | Incidence of complications to placement of the biodegradable stent, including displacement. | 30 days |
| Postoperative complications | Overall incidence of complications following PD classified according to Clavien-Dindo |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Capitol | 2100 | Denmark |
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| ID | Term |
|---|---|
| D010185 | Pancreatic Fistula |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D020763 | Pathological Conditions, Anatomical |
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prospective, randomized, blinded clinical superiority trial
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The investigators will mask the allocation for the outcome assessors and trial statistician who will conduct the analyses, and the author group while writing the abstract for the trial report with the two intervention groups coded as 0 and 1. Due to the nature of the intervention and control, the trial will not be blinded for the surgeons performing the interventions
| 30 days postoperative |
| Mortality | Participant Mortality at 30 and 90 days | 30 days and 90 days |
| LOS | Participant Length of hospital stay (LOS). | Length in days, from surgery until discharge ( up to 200 days from surgery) |
| Quality of Life according to VR12 Quality of Life Score | Patient reported quality of life according to VR12 Quality of Life Score (activity level, pain episodes, pain levels, patient mood) | 30 days post surgery |
| D013568 | Pathological Conditions, Signs and Symptoms |