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

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ClinicalTrials.gov Identifier: NCT03030170
Recruitment Status : Active, not recruiting
First Posted : January 24, 2017
Last Update Posted : April 14, 2021
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Tracking Information
First Submitted Date  ICMJE January 16, 2017
First Posted Date  ICMJE January 24, 2017
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE June 28, 2017
Actual Primary Completion Date December 14, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF [ Time Frame: up to 90 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • Gravity of the pancreatic fistula according to the 3 stages of ISGPF [ Time Frame: up to 90 days ]
  • Assessment of the occurrence of gastroparesis and its severity according to the criteria of ISGPS [ Time Frame: up to 90 days ]
  • Evaluation of the occurrence of postoperative haemorrhage [ Time Frame: up to 90 days ]
  • Length of hospital stay [ Time Frame: up to 90 days ]
  • Perioperative mortality and 90-day mortality [ Time Frame: up to 90 days ]
  • Overall morbidity classified and categorized according to the classification of Dindo and Clavien [ Time Frame: until 90 days ]
  • Rehospitalization rates [ Time Frame: until 90 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
intervention with reinforced medical device, or not
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Distal Pancreatectomy (DP)
Intervention  ICMJE
  • Device: ENDO GIA X-tra Thick reload with Tri Staple Technology
    Suture of the pancreas by normal stapling
  • Device: ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology
    Suture of the pancreas by reinforced stapling
Study Arms  ICMJE
  • Experimental: Experimental
    Stapling of the pancreas with ENDO GIA Reinforced reload
    Intervention: Device: ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology
  • Active Comparator: Control
    Stapling of the pancreas with ENDO GIA X-tra Thick reload
    Intervention: Device: ENDO GIA X-tra Thick reload with Tri Staple Technology
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 13, 2021)
207
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
200
Estimated Study Completion Date  ICMJE April 30, 2021
Actual Primary Completion Date December 14, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03030170
Other Study ID Numbers  ICMJE 35RC15_9846
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Rennes University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rennes University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: LAURENT SULPICE, MD/PHD RENNES PONTCHAILLOU HOSPITAL
PRS Account Rennes University Hospital
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP