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OpenTrials
Completed

NCT Number: NCT03030170

REinforcement of the Pancreas in distaL pAncreatectomY (REPLAY)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service de chirurgie Hépato-pancréato-biliaire, Clichy, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ENDO GIA X-tra Thick reload with Tri Staple Technology

Device

Suture of the pancreas by normal stapling

ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology

Device

Suture of the pancreas by reinforced stapling

Primary outcomes

  1. Rate of postoperative pancreatic fistula defined by the criteria of the ISGPF

    Time frame: up to 90 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study 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

Acronym: REPLAY

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jan 24, 2017
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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