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Despite an improvement regarding morbidity and mortality since 30 years, especially in expert centers, pancreatic surgery remains currently associated to a significant postoperative morbidity reaching more than 60%. Regarding distal pancreatectomy (DP), the main complication following surgery is the occurrence of postoperative pancreatic fistula (PF) which may be able to lead an increased risk of bleeding, gastroparesis and finally a longer hospital stays. The main risk factors associated to the occurrence of pancreatic fistula are represented by the texture of the pancreatic parenchyma (soft pancreas) and the caliber of the main pancreatic duct (<3mm). Looking for new means of reducing the occurrence of pancreatic fistula is a priority in pancreatic surgery and a genuine public health issue. Currently, no formal recommendations concerning the optimal technical for closure of the distal stump in DP are available. In fact, manual closing by elective suturing or stapling of the main pancreatic duct give similar results. The use of a reinforcing stapling potentially represents a simple way to decrease the occurrence of pancreatic fistula and requires evaluation by a prospective randomized study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Stapling of the pancreas with ENDO GIA Reinforced reload |
|
| Control | Active Comparator | Stapling of the pancreas with ENDO GIA X-tra Thick reload |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDO GIA X-tra Thick reload with Tri Staple Technology | Device | Suture of the pancreas by normal stapling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF | up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Gravity of the pancreatic fistula according to the 3 stages of ISGPF | up to 90 days | |
| Assessment of the occurrence of gastroparesis and its severity according to the criteria of ISGPS | up to 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LAURENT SULPICE, MD/PHD | RENNES PONTCHAILLOU HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de chirurgie Hépato-pancréato-biliaire | Clichy | 92110 | France | |||
| Service de chirurgie générale, digestive et de la transplantation hépatique |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35876371 | Derived | Merdrignac A, Garnier J, Dokmak S, Regenet N, Lesurtel M, Mabrut JY, Sa Cunha A, Fuks D, Bergeat D, Robin F, Le Pabic E, Boudjema K, Turrini O, Laviolle B, Sulpice L. Effect of the Use of Reinforced Stapling on the Occurrence of Pancreatic Fistula After Distal Pancreatectomy: Results of the REPLAY (REinforcement of the Pancreas in distaL pAncreatectomY) Multicenter Randomized Clinical Trial. Ann Surg. 2022 Nov 1;276(5):769-775. doi: 10.1097/SLA.0000000000005618. Epub 2022 Jul 25. |
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intervention with reinforced medical device, or not
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| ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology | Device | Suture of the pancreas by reinforced stapling |
|
| Evaluation of the occurrence of postoperative haemorrhage | up to 90 days |
| Length of hospital stay | up to 90 days |
| Perioperative mortality and 90-day mortality | up to 90 days |
| Overall morbidity classified and categorized according to the classification of Dindo and Clavien | until 90 days |
| Rehospitalization rates | until 90 days |
| Lyon |
| 69317 |
| France |
| AP-HM - Institut Paoli Calmettes_ service de chirurgie oncologique digestive | Marseille | 13009 | France |
| Service de chirurgie digestive et endocrienne | Nantes | 44093 | France |
| Institut Mutualiste Montsouris | Paris | 75674 | France |
| Centre Hospitalier Universitaire Rennes Pontchaillou | Rennes | 35000 | France |
| Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique | Villejuif | 94800 | France |