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REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY) (REPLAY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030170
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Distal Pancreatectomy (DP) Device: ENDO GIA X-tra Thick reload with Tri Staple Technology Device: ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: intervention with reinforced medical device, or not
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Does the Strengthening of the Pancreas in Distal Pancreatectomy Using Endo GIA Reload Reinforced Reduce the Occurrence of Pancreatic Fistula? Multicenter Randomized Prospective Open Study
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: Experimental
Stapling of the pancreas with ENDO GIA Reinforced reload
Device: ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology
Suture of the pancreas by reinforced stapling

Active Comparator: Control
Stapling of the pancreas with ENDO GIA X-tra Thick reload
Device: ENDO GIA X-tra Thick reload with Tri Staple Technology
Suture of the pancreas by normal stapling




Primary Outcome Measures :
  1. Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF [ Time Frame: up to 90 days ]

Secondary Outcome Measures :
  1. Gravity of the pancreatic fistula according to the 3 stages of ISGPF [ Time Frame: up to 90 days ]
  2. Assessment of the occurrence of gastroparesis and its severity according to the criteria of ISGPS [ Time Frame: up to 90 days ]
  3. Evaluation of the occurrence of postoperative haemorrhage [ Time Frame: up to 90 days ]
  4. Length of hospital stay [ Time Frame: up to 90 days ]
  5. Perioperative mortality and 90-day mortality [ Time Frame: up to 90 days ]
  6. Overall morbidity classified and categorized according to the classification of Dindo and Clavien [ Time Frame: until 90 days ]
  7. Rehospitalization rates [ Time Frame: until 90 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who undergo DP whether made by open or laparoscopic surgery
  • Patients 18 years of age or older,
  • Benefiting from a social security scheme,
  • Having given his free, informed and written consent.

Exclusion Criteria:

  • History of pancreatic abdominal surgery
  • Severe co-morbidity type renal failure requiring hemodialysis, unbalanced diabetes, major respiratory insufficiency, heart failure ≥ stage 3 NYHA;
  • Persons of full age who are subject to legal protection, persons deprived of liberty.
  • Pregnant or nursing women
  • Patients participating in or participating in another study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030170


Contacts
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Contact: LAURENT SULPICE, MD/PHD laurent.sulpice@chu-rennes.fr
Contact: AUDE MERDRIGNAC, MD aude.merdrignac@chu-rennes.fr

Locations
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France
Service de chirurgie Hépato-pancréato-biliaire Not yet recruiting
Clichy, France, 92110
Contact: Safi DOKMAK, MD    +33 40 87 59 48    safi.dokmak@aphp.fr   
Service de chirurgie générale, digestive et de la transplantation hépatique Recruiting
Lyon, France, 69317
Contact: Jean-Yves MABRUT, MD/PHD    +33 4 72 07 11 00    jean-yves.mabrut@chu-lyon.fr   
AP-HM - Institut Paoli Calmettes_ service de chirurgie oncologique digestive Recruiting
Marseille, France, 13009
Contact: Turrini Olivier, MD    +33 4 91 22 33 33    turrinio@ipc.unicancer.fr   
Service de chirurgie digestive et endocrienne Recruiting
Nantes, France, 44093
Contact: REGENET Nicolas, MD    +33 2 40 08 30 22    nicolas.regenet@chu-nantes.fr   
Institut Mutualiste Montsouris Not yet recruiting
Paris 14, France, 75674
Contact: David FUKS, MD    01 56 61 63 36    david.fuks@imm.fr   
Centre Hospitalier Universitaire Rennes Pontchaillou Recruiting
Rennes, France, 35000
Contact: Laurent Sulpice, PH    +0033299289004    laurent.sulpice@chu-rennes.fr   
Contact: Aude Merdrignac, D       aude.merdrignac@chu-rennes.fr   
Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique Recruiting
Villejuif, France, 94800
Contact: Sa Cunha Antonio, MD/PHD    +33 1 45 59 32 07    antonio.sacunha@pbr.aphp.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: LAURENT SULPICE, MD/PHD RENNES PONTCHAILLOU HOSPITAL
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03030170    
Other Study ID Numbers: 35RC15_9846
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No