Distal Pancreatectomy (DP)Phase 3REPLAYNCT03030170
REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY)
A Phase 3 study testing ENDO GIA X-tra Thick reload with Tri Staple Technology and ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology in people with Distal Pancreatectomy (DP), run by Rennes University Hospital at 7 sites in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Pancreatectomy (DP)
- What is being tested?
- ENDO GIA X-tra Thick reload with Tri Staple Technology and ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 7 sitesFrance
- Study dates
- 28 Jun 2017to 30 Jul 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Service de chirurgie Hépato-pancréato-biliaire
Clichy, 92110
Service de chirurgie générale, digestive et de la transplantation hépatique
Lyon, 69317
AP-HM - Institut Paoli Calmettes_ service de chirurgie oncologique digestive
Marseille, 13009
Service de chirurgie digestive et endocrienne
Nantes, 44093
Institut Mutualiste Montsouris
Paris, 75674
Centre Hospitalier Universitaire Rennes Pontchaillou
Rennes, 35000
Unité d'hospitalisation Chirurgie hépatique, biliaire et pancréatique
Villejuif, 94800
About this study
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
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.
- Conditions
- Distal Pancreatectomy (DP)
- Being tested
- ENDO GIA X-tra Thick reload with Tri Staple Technology, ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDO GIA X-tra Thick reload with Tri Staple TechnologyDevice
Suture of the pancreas by normal stapling
ENDO GIA Articulating Reinforced Reload with Tri-Staple TechnologyDevice
Suture of the pancreas by reinforced stapling
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Stapling of the pancreas with ENDO GIA Reinforced reload Receives: Device: ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology |
| Control | Active comparator | Stapling of the pancreas with ENDO GIA X-tra Thick reload Receives: Device: ENDO GIA X-tra Thick reload with Tri Staple Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF
Measured: up to 90 days
Secondary outcomes (7)
Gravity of the pancreatic fistula according to the 3 stages of ISGPF
Measured: up to 90 days
Assessment of the occurrence of gastroparesis and its severity according to the criteria of ISGPS
Measured: up to 90 days
Evaluation of the occurrence of postoperative haemorrhage
Measured: up to 90 days
Length of hospital stay
Measured: up to 90 days
Perioperative mortality and 90-day mortality
Measured: up to 90 days
Overall morbidity classified and categorized according to the classification of Dindo and Clavien
Measured: until 90 days
Rehospitalization rates
Measured: until 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2017 (estimated)
- Study start28 Jun 2017
- Primary completion14 Dec 2020
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Pancreatectomy (DP)Studies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention with reinforced medical device, or not
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LAURENT SULPICE, MD/PHD, Principal investigator, RENNES PONTCHAILLOU HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030170
- Sponsor's protocol ID
- 35RC15_9846
- Acronym
- REPLAY
- Status last verified
- Aug 2023
- First submitted
- 16 Jan 2017
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35876371
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03030170
- Acronym / sponsor ID
- REPLAY / 35RC15_9846
- Conditions
- Distal Pancreatectomy (DP)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 24 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention with reinforced medical device, or not
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: ENDO GIA Articulating Reinforced Reload with Tri-Staple TechnologyStapling of the pancreas with ENDO GIA Reinforced reload |
| Control | Active comparator | Device: ENDO GIA X-tra Thick reload with Tri Staple TechnologyStapling of the pancreas with ENDO GIA X-tra Thick reload |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENDO GIA X-tra Thick reload with Tri Staple TechnologySuture of the pancreas by normal stapling | Device | Control |
| ENDO GIA Articulating Reinforced Reload with Tri-Staple TechnologySuture of the pancreas by reinforced stapling | Device | Experimental |
Primary outcome
Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF
Time frame: up to 90 days
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Derived from this study: PubMed 35876371Merdrignac 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LAURENT SULPICE, MD/PHD principal investigator
RENNES PONTCHAILLOU HOSPITAL
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ENDO GIA X-tra Thick reload with Tri Staple Technology and ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology in people with Distal Pancreatectomy (DP), run by Rennes University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF (time frame: up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03030170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.