Trials / Completed
CompletedNCT04724174
Pancreaticogastrostomy for High-Risk Pancreas
Double Purse-String Telescoped Pancreaticogastrostomy for High Risk Anastomosis: A 6-Year Single Center Case-Controlled Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 198 (actual)
- Sponsor
- Institut Paoli-Calmettes · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In 2013, a double purse-string telescoped pancreaticogastrostomy (PG) technique appeared to significantly reduce the risk of postoperative pancreatic fistula (POPF). This study compared the incidence of clinically relevant POPF in patients with high-risk anastomosis after undergoing PG or pancreaticojejunostomy (PJ) techniques.
Detailed description
From 2013 to 2019, consecutive patients with high-risk anastomosis (i.e., updated alternative-Fistula Risk Score (ua-FRS) \>20%) underwent pancreatoduodenectomy with either the PJ or PG technique. Optimal mitigation strategy (external stenting and octreotide omission) was applied for all patients. The primary endpoint of the study was the incidence of clinically relevant POPF. Data were entered prospectively into an institutional clinical database (NCT02871336).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | pancreaticogastrostomy | Pancreaticogastrostomy technique was performed according to the precise description of Addeo et al. |
| PROCEDURE | pancreaticojejunostomy | Pancreaticojejunostomy technique was performed using the 5/0 polypropylene interrupted monofilament suture in a one-layered duct-to-mucosa end-to-side anastomosis (Cattell-Warren anastomosis). |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2020-01-01
- Completion
- 2020-01-31
- First posted
- 2021-01-26
- Last updated
- 2021-01-26
Source: ClinicalTrials.gov record NCT04724174. Inclusion in this directory is not an endorsement.