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

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

Tracking Information

• First Submitted Date: January 16, 2017
• First Posted Date: January 24, 2017
• Last Update Posted Date: April 14, 2021
• Actual Study Start Date: June 28, 2017
• Actual Primary Completion Date: December 14, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: REinforcement of the Pancreas in distaL pAncreatectomY (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
• 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: Interventional
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

intervention with reinforced medical device, or not

Masking: None (Open Label)
Primary Purpose: Other

• Condition: Distal Pancreatectomy (DP)

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 13, 2021): 207
• Original Estimated Enrollment (submitted: January 23, 2017): 200
• Estimated Study Completion Date: April 30, 2021
• Actual Primary Completion Date: December 14, 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03030170
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: Rennes University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Rennes University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: LAURENT SULPICE, MD/PHD; RENNES PONTCHAILLOU HOSPITAL

• PRS Account: Rennes University Hospital
• Verification Date: April 2021