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REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY)

NCT03030170 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2023-08-09

No results posted yet for this study

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.

Conditions

  • Distal Pancreatectomy (DP)

Interventions

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

Sponsors & Collaborators

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • LAURENT SULPICE, MD/PHD · RENNES PONTCHAILLOU HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2020-12-14
Completion
2021-07-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03030170 on ClinicalTrials.gov