NCT03880773

Brief 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. 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 19, 2019

Status Verified

January 1, 2019

Enrollment Period

2.5 years

First QC Date

February 25, 2019

Last Update Submit

March 18, 2019

Conditions

Pancreatic FistulaDistal Pancreatectomy

Outcome Measures

Primary Outcomes (1)

  • Rate of Pancreatic fistula

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

    90 days

Secondary Outcomes (4)

  • Operative time

    intra-operatively

  • Rate of postoperative overall and specific complications

    30 days, 90 days

  • Rate of re-operations or percutaneous drainage

    30 days, 90 days

  • Cost-analysis

    90 days

Study Arms (2)

Stapler

EXPERIMENTAL
Device: Stapler

ultrasonic shears

ACTIVE COMPARATOR
Device: ultrasonic shears

Interventions

StaplerDEVICE

for transection of the pancreas and pancreatic stump treatment

Stapler
ultrasonic shearsDEVICE

for transection of the pancreas and pancreatic stump treatment

ultrasonic shears

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Immune suppressed patients
  • Pregnant women
  • Patients with contraindications for distal pancreatectomy
  • Impaired mental state or language problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Policlinico GB Rossi

Verona, 37134, Italy

RECRUITING

Related Publications (8)

  • 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.

    PMID: 22526040BACKGROUND

  • 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.

    PMID: 10361178BACKGROUND

  • 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.

    PMID: 17414606BACKGROUND

  • 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.

    PMID: 15852419BACKGROUND

  • 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.

    PMID: 21529927BACKGROUND

  • 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.

    PMID: 25388952BACKGROUND

  • 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.

    PMID: 27583852BACKGROUND

  • 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.

    PMID: 28298641BACKGROUND

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

Surgical Staplers

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical InstrumentsSurgical EquipmentEquipment and Supplies

Central Study Contacts

Erica Secchettin

CONTACT

0458126254erica.secchettin@aovr.veneto.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 19, 2019

Study Start

July 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 19, 2019

Record last verified: 2019-01

Locations

IT(1)