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History of Changes for Study: NCT03030170
REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY) (REPLAY)
Latest version (submitted April 13, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 23, 2017 None (earliest Version on record)
2 February 7, 2017 Conditions, Study Description and Study Status
3 September 10, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 May 17, 2019 Study Status and Contacts/Locations
5 April 13, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Study NCT03030170
Submitted Date:  January 23, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: 35RC15_9846
Brief Title: REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY) (REPLAY)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2017
Overall Status: Not yet recruiting
Study Start: February 2017
Primary Completion: May 2017 [Anticipated]
Study Completion: May 2019 [Anticipated]
First Submitted: January 16, 2017
First Submitted that
Met QC Criteria:
January 23, 2017
First Posted: January 24, 2017 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 23, 2017
Last Update Posted: January 24, 2017 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Rennes University Hospital
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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% (1, 2). 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 (3). 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 (4, 5). In fact, manual closing by elective suturing or stapling of the main pancreatic duct give similar results (6). 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.
Detailed Description:
Open or close this module Conditions
Conditions: Pancreaticoduodenectomy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: LAURENT SULPICE, MD/PHD
Email: laurent.sulpice@chu-rennes.fr
Central Contact Backup: AUDE MERDRIGNAC, MD
Email: aude.merdrignac@chu-rennes.fr
Study Officials: LAURENT SULPICE, MD/PHD
Principal Investigator
RENNES PONTCHAILLOU HOSPITAL
Locations: France
Service de chirurgie Hépato-pancréato-biliaire
Clichy, France, 92110
Contact:Contact: Safi DOKMAK, MD +33 40 87 59 48 safi.dokmak@aphp.fr
Service de chirurgie générale, digestive et de la transplantation hépatique
Lyon, France, 69317
Contact: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
Marseille, France, 13009
Contact:Contact: Turrini Olivier, MD +33 4 91 22 33 33 turrinio@ipc.unicancer.fr
Service de chirurgie digestive et endocrienne
Nantes, France, 44093
Contact:Contact: REGENET Nicolas, MD +33 2 40 08 30 22 nicolas.regenet@chu-nantes.fr
Centre Hospitalier Universitaire Rennes Pontchaillou
Rennes, France, 35000
Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique
Villejuif, France, 94800
Contact:Contact: Sa Cunha Antonio, MD/PHD +33 1 45 59 32 07 antonio.sacunha@pbr.aphp.fr
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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