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Pancreatic FistulaTRUDYNCT03880773

Comparison Between Two Methods of Pancreatic Transection in Distal Pancreatectomy

A study testing Stapler and ultrasonic shears in people with Pancreatic Fistula and Distal Pancreatectomy, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Several systematic reviews have investigated the management of the pancreatic stump in order to reduce the postoperative pancreatic fistula (POPF) rate after distal pancreatectomy (DP). The appropriate closure technique of the pancreatic stump is still debated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Fistula, Distal Pancreatectomy
What is being tested?
Stapler and ultrasonic shears
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteItaly
Study dates
1 Jul 2018to 31 Dec 2020
Phase
Interventional
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

  • Scheduled for elective DP via a minimally invasive (laparoscopic or robotic) or open technique, either preserving the spleen or with splenectomy, depending on the diagnosis/nature of the tumor
  • ASA score < 4
  • Ability of the subject to understand character and individual consequences of the clinical trial
  • Written informed consent

Who cannot join

  • Pancreas thickness >17mm measured at the intraoperative ultrasound at the pancreatic transection level
  • Metastatic disease
  • Kidney or adrenal gland resection
  • Arterial resection (celiac axis, superior mesenteric artery, hepatic artery)
  • Intestinal resections and anastomoses or stoma
  • Acute necrotizing and chronic pancreatitis
Show all 10Show fewer
  • Immune suppressed patients
  • Pregnant women
  • Patients with contraindications for distal pancreatectomy
  • Impaired mental state or language problems

Trial locations and contacts

1 site in 1 country.

Erica Secchettin contact

0458126254

erica.secchettin@aovr.veneto.it

Italy1 site, 1 recruiting

  • Ospedale Policlinico GB Rossi

    Verona, 37134

    Luca Landoni, MD, 0458126254 ext. 0039, luca.landoni@aovr.veneto.it

    Claudio Bassi, MD

    Recruiting

Other trials in Italy

About this study

Official title: Tri Stapler vs. Ultrasonic Scalpel in Distal Pancreatectomy

Several systematic reviews have investigated the management of the pancreatic stump in order to reduce the postoperative pancreatic fistula (POPF) rate after distal pancreatectomy (DP). The appropriate closure technique of the pancreatic stump is still debated. There is no published experience about the comparison of the Endo GIA Reinforced Reload with Tri-Staple Technology (TS) versus Harmonic Focus (US) after distal pancreatectomy (DP) regarding the reduction of POPF.

The investigators want to compare the incidence of clinically-relevant POPF (CR-POPF) after DP, depending upon the transection technique (TS versus US).

Read more

This is a randomized controlled, multicenter, patient-blinded, superiority trial. This protocol was designed according to the SPIRIT guidelines.

Two groups of 76 patients (152 in total) with an indication for elective minimally invasive or open DP for a lesion of the body-tail of the pancreas. The two techniques analyzed are Endo GIA Reinforced Reload with Tri-Staple Technology (TS) and Harmonic Focus (US) as control.

The primary endpoint is to evaluate the incidence of CR-POPF rate after DP. Secondary endpoints are intraoperative outcomes (blood loss, operative time and conversion of the minimally invasive procedure), postoperative outcomes (complications rate; hospitalization parameters to 90 days; mortality) and treatment costs.

Being tested
Stapler, ultrasonic shears
Medical subject headings
Pancreatic Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StaplerDevice

    for transection of the pancreas and pancreatic stump treatment

  • ultrasonic shearsDevice

    for transection of the pancreas and pancreatic stump treatment

Study groups in NCT03880773
Study groupRoleWhat they receive
StaplerExperimentalNot described
Receives: Device: Stapler
ultrasonic shearsActive comparatorNot described
Receives: Device: ultrasonic shears

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Pancreatic fistula

    pancreatic fistula according to International Study Group of Pancreatic Surgery (ISGPS) 2017 definition

    Measured: 90 days

Secondary outcomes (4)

  1. Operative time

    Measured: intra-operatively

  2. Rate of postoperative overall and specific complications

    abdominal collections, delayed gastric emptying, hemorrhage, sepsis, wound infections

    Measured: 30 days, 90 days

  3. Rate of re-operations or percutaneous drainage

    re-operations rate or percutaneous drainage rate

    Measured: 30 days, 90 days

  4. Cost-analysis

    intra and post-operative costs

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2019
  2. Study start1 Jul 2018
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03880773
Sponsor's protocol ID
TRUDY
Acronym
TRUDY
Status last verified
Jan 2019
First submitted
25 Feb 2019
Last updated
19 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ban D, Shimada K, Konishi M, Saiura A, Hashimoto M, Uesaka K. Stapler and nonstapler closure of the pancreatic remnant after distal pancreatectomy: multicenter retrospective analysis of 388 patients. World J Surg. 2012 Aug;36(8):1866-73. doi: 10.1007/s00268-012-1595-z.

    PubMed 22526040

  • Suzuki Y, Fujino Y, Tanioka Y, Hori Y, Ueda T, Takeyama Y, Tominaga M, Ku Y, Yamamoto YM, Kuroda Y. Randomized clinical trial of ultrasonic dissector or conventional division in distal pancreatectomy for non-fibrotic pancreas. Br J Surg. 1999 May;86(5):608-11. doi: 10.1046/j.1365-2168.1999.01120.x.

    PubMed 10361178

  • Kleeff J, Diener MK, Z'graggen K, Hinz U, Wagner M, Bachmann J, Zehetner J, Muller MW, Friess H, Buchler MW. Distal pancreatectomy: risk factors for surgical failure in 302 consecutive cases. Ann Surg. 2007 Apr;245(4):573-82. doi: 10.1097/01.sla.0000251438.43135.fb.

    PubMed 17414606

  • Knaebel HP, Diener MK, Wente MN, Buchler MW, Seiler CM. Systematic review and meta-analysis of technique for closure of the pancreatic remnant after distal pancreatectomy. Br J Surg. 2005 May;92(5):539-46. doi: 10.1002/bjs.5000.

    PubMed 15852419

  • Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Buchler MW. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011 Apr 30;377(9776):1514-22. doi: 10.1016/S0140-6736(11)60237-7.

    PubMed 21529927

  • Zhang H, Zhu F, Shen M, Tian R, Shi CJ, Wang X, Jiang JX, Hu J, Wang M, Qin RY. Systematic review and meta-analysis comparing three techniques for pancreatic remnant closure following distal pancreatectomy. Br J Surg. 2015 Jan;102(1):4-15. doi: 10.1002/bjs.9653. Epub 2014 Nov 12.

    PubMed 25388952

  • Kim H, Jang JY, Son D, Lee S, Han Y, Shin YC, Kim JR, Kwon W, Kim SW. Optimal stapler cartridge selection according to the thickness of the pancreas in distal pancreatectomy. Medicine (Baltimore). 2016 Aug;95(35):e4441. doi: 10.1097/MD.0000000000004441.

    PubMed 27583852

  • Peng YP, Zhu XL, Yin LD, Zhu Y, Wei JS, Wu JL, Miao Y. Risk factors of postoperative pancreatic fistula in patients after distal pancreatectomy: a systematic review and meta-analysis. Sci Rep. 2017 Mar 15;7(1):185. doi: 10.1038/s41598-017-00311-8.

    PubMed 28298641

Questions about this trial

What is this clinical trial studying?

A study testing Stapler and ultrasonic shears in people with Pancreatic Fistula and Distal Pancreatectomy, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.

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 10 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: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Erica Secchettin (0458126254, erica.secchettin@aovr.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Pancreatic fistula (time frame: 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 NCT03880773, which also lists 8 linked publications.

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 19 Mar 2019.

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