The Influence of Two Different Hepatectomy Methods on Transection Speed and Chemokine Release From the Liver

NCT01785212 | Completed

• 1 other identifier: Version 1.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The CUSA (cavitron ultrasound surgical aspirator) is the method of choice for hepatic resection in our center. Recently a stapler-hepatectomy methods has been developed and approved for liver surgery using Covidien Endo-Gia stapler. The potential benefit of this method is a potential shorter transection time compared to the CUSA technique. Thus the investigators will perform a randomized controlled trial including 20 patients in the stapler-group and 20 patients in the CUSA control group. Primary endpoint will be transection speed. Secondary endpoints will be peri-operative (d-1, d0, d1, d3) cytokines concentration, T cell subsets, blood loss, morbidity, and a cost analysis.

Conditions

Liver Neoplasms; Liver Metastasis; Liver Hemangioma; Echinococcosis, Hepatic

Outcome Measures

Primary Outcomes (1)

• transection speed

  The transection time will be recorded by the anesthesiological team during surgery. The transection phase starts with opening the liver parenchyma after the transection line has been marked by electrocautery. It ends after complete division of the liver parenchyma. The cut surface of the resected liver will be photographed together with a 4 cm² reference scale in an exact 90° angle. The area of the liver transection surface will be calculated in cm² by setting the measured pixels of the cut surface in relation to the reference scale using Adobe Photoshop. The transection speed will expressed in cm²/min

  during surgery

Secondary Outcomes (5)

• Perioperative cytokine concentrations

  day -1, d0, d1, d3

• Intraoperative blood loss in ml

  during surgery

• Postoperative laboratory markers of liver damage

  first week after surgery

• Morbidity and Mortality

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

• Perioperative T-cell subsets

  Day -1, 0, 1, 3

Other Outcomes (1)

• Costs and health economics

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Study Arms (2)

Stapler-hepatectomy

OTHER

The liver parenchyma is crushed with a Pean clamp and subsequently divided using Covidien Endo-Gia™ Ultra Handle Short Staplers and Endo Gia™ TRI staple 60 mm or 45 mm AVM/AMT loading units (Covidien). Hepatic veins and portal pedicles clamped and suture ligated.

Device: Stapler

CUSA-hepatectomy

OTHER

The liver parenchyma is divided along the transection line by CUSA (Cavitron ultrasonic aspirator; Valleylab, Boulder, CO) and bipolar forceps in a two surgeon technique. Vessels of less than 2 mm in diameter are coagulated with bipolar forceps. The remaining vessels are clipped or ligated. Hepatic veins and portal pedicles clamped and suture ligated.

Device: CUSA (Cavitron ultrasonic aspirator; Valleylab, Boulder, CO)

Interventions

Stapler DEVICE

stapler hepatectomy

Also known as: Covidien Endo-Gia™ Ultra Handle Short Staplers(Covidien)

Stapler-hepatectomy

CUSA (Cavitron ultrasonic aspirator; Valleylab, Boulder, CO) DEVICE

CUSA is a well established device used for hepatic resection using ultrasound

CUSA-hepatectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective major hepatic resection at the Department of General Surgery, Medical University of Vienna
• Stapler hepatectomy and CUSA resection feasible based on preoperative imaging
• Age equal or greater than 18 years
• Informed consent

You may not qualify if:

• Minor hepatectomy
• Hepatitis B, Hepatitis C, HIV infection, autoimmune disease
• Inflammatory conditions of the bowel such as Crohn's Disease
• Pregnancy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Dept. of Surgery/Div. of General Surgery Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (14)

• Gurusamy KS, Pamecha V, Sharma D, Davidson BR. Techniques for liver parenchymal transection in liver resection. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD006880. doi: 10.1002/14651858.CD006880.pub2.

  PMID: 19160307 BACKGROUND

• Jarnagin WR, Gonen M, Fong Y, DeMatteo RP, Ben-Porat L, Little S, Corvera C, Weber S, Blumgart LH. Improvement in perioperative outcome after hepatic resection: analysis of 1,803 consecutive cases over the past decade. Ann Surg. 2002 Oct;236(4):397-406; discussion 406-7. doi: 10.1097/01.SLA.0000029003.66466.B3.

  PMID: 12368667 BACKGROUND

• Rahbari NN, Elbers H, Koch M, Bruckner T, Vogler P, Striebel F, Schemmer P, Mehrabi A, Buchler MW, Weitz J. Clamp-crushing versus stapler hepatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH)--a randomized controlled trial (NCT01049607). BMC Surg. 2011 Sep 4;11:22. doi: 10.1186/1471-2482-11-22.

  PMID: 21888669 BACKGROUND

• Tamandl D, Gruenberger B, Herberger B, Kaczirek K, Gruenberger T. Surgery after neoadjuvant chemotherapy for colorectal liver metastases is safe and feasible in elderly patients. J Surg Oncol. 2009 Oct 1;100(5):364-71. doi: 10.1002/jso.21259.

  PMID: 19235181 BACKGROUND

• Tamandl D, Gruenberger B, Klinger M, Herberger B, Kaczirek K, Fleischmann E, Gruenberger T. Liver resection remains a safe procedure after neoadjuvant chemotherapy including bevacizumab: a case-controlled study. Ann Surg. 2010 Jul;252(1):124-30. doi: 10.1097/SLA.0b013e3181deb67f.

  PMID: 20562613 BACKGROUND

• Kimura F, Shimizu H, Yoshidome H, Ohtsuka M, Kato A, Yoshitomi H, Nozawa S, Furukawa K, Mitsuhashi N, Sawada S, Takeuchi D, Ambiru S, Miyazaki M. Circulating cytokines, chemokines, and stress hormones are increased in patients with organ dysfunction following liver resection. J Surg Res. 2006 Jun 15;133(2):102-12. doi: 10.1016/j.jss.2005.10.025. Epub 2006 Jan 4.

  PMID: 16386757 BACKGROUND

• Yamauchi H, Kobayashi E, Yoshida T, Kiyozaki H, Hozumi Y, Kohiyama R, Suminaga Y, Sakurabayashi I, Fujimura A, Miyata M. Changes in immune-endocrine response after surgery. Cytokine. 1998 Jul;10(7):549-54. doi: 10.1006/cyto.1997.0322.

  PMID: 9702420 BACKGROUND

• Cruickshank AM, Fraser WD, Burns HJ, Van Damme J, Shenkin A. Response of serum interleukin-6 in patients undergoing elective surgery of varying severity. Clin Sci (Lond). 1990 Aug;79(2):161-5. doi: 10.1042/cs0790161.

  PMID: 2167805 BACKGROUND

• Baigrie RJ, Lamont PM, Kwiatkowski D, Dallman MJ, Morris PJ. Systemic cytokine response after major surgery. Br J Surg. 1992 Aug;79(8):757-60. doi: 10.1002/bjs.1800790813.

  PMID: 1393463 BACKGROUND

• Mokart D, Merlin M, Sannini A, Brun JP, Delpero JR, Houvenaeghel G, Moutardier V, Blache JL. Procalcitonin, interleukin 6 and systemic inflammatory response syndrome (SIRS): early markers of postoperative sepsis after major surgery. Br J Anaesth. 2005 Jun;94(6):767-73. doi: 10.1093/bja/aei143. Epub 2005 Apr 22.

  PMID: 15849208 BACKGROUND

• Jawa RS, Anillo S, Huntoon K, Baumann H, Kulaylat M. Interleukin-6 in surgery, trauma, and critical care part II: clinical implications. J Intensive Care Med. 2011 Mar-Apr;26(2):73-87. doi: 10.1177/0885066610384188.

  PMID: 21464062 BACKGROUND

• Zhai Y, Busuttil RW, Kupiec-Weglinski JW. Liver ischemia and reperfusion injury: new insights into mechanisms of innate-adaptive immune-mediated tissue inflammation. Am J Transplant. 2011 Aug;11(8):1563-9. doi: 10.1111/j.1600-6143.2011.03579.x. Epub 2011 Jun 10.

  PMID: 21668640 BACKGROUND

• Caldwell CC, Tschoep J, Lentsch AB. Lymphocyte function during hepatic ischemia/reperfusion injury. J Leukoc Biol. 2007 Sep;82(3):457-64. doi: 10.1189/jlb.0107062. Epub 2007 Apr 30.

  PMID: 17470532 BACKGROUND

• Schwarz C, Klaus DA, Tudor B, Fleischmann E, Wekerle T, Roth G, Bodingbauer M, Kaczirek K. Transection Speed and Impact on Perioperative Inflammatory Response - A Randomized Controlled Trial Comparing Stapler Hepatectomy and CUSA Resection. PLoS One. 2015 Oct 9;10(10):e0140314. doi: 10.1371/journal.pone.0140314. eCollection 2015.

  PMID: 26452162 DERIVED

MeSH Terms

Conditions

Liver Neoplasms; Echinococcosis, Hepatic

Interventions

Surgical Staplers

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Echinococcosis; Cestode Infections; Helminthiasis; Parasitic Diseases; Infections; Liver Diseases, Parasitic

Intervention Hierarchy (Ancestors)

Surgical Instruments; Surgical Equipment; Equipment and Supplies

Study Officials

• Klaus Kaczirek, M.D.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: February 7, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

AU (1)