Comparison Between Two Methods of Pancreatic Transection in Distal Pancreatectomy
NCT ID: NCT03880773
Last Updated: 2019-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
152 participants
INTERVENTIONAL
2018-07-01
2020-12-31
Brief Summary
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The investigators want to compare the incidence of clinically-relevant POPF (CR-POPF) after DP, depending upon the transection technique (TS versus US).
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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Stapler
Stapler
for transection of the pancreas and pancreatic stump treatment
ultrasonic shears
ultrasonic shears
for transection of the pancreas and pancreatic stump treatment
Interventions
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Stapler
for transection of the pancreas and pancreatic stump treatment
ultrasonic shears
for transection of the pancreas and pancreatic stump treatment
Eligibility Criteria
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Inclusion Criteria
* ASA score \< 4
* Ability of the subject to understand character and individual consequences of the clinical trial
* Written informed consent
Exclusion Criteria
* 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
* Immune suppressed patients
* Pregnant women
* Patients with contraindications for distal pancreatectomy
* Impaired mental state or language problems
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera Universitaria Integrata Verona
OTHER
Responsible Party
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Locations
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Ospedale Policlinico GB Rossi
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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TRUDY
Identifier Type: -
Identifier Source: org_study_id
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