Laparoscopic Microwave Ablation and Portal Vein Ligation for Staged Hepatectomy (LAPS)

NCT02184182 | Unknown Phase 2

• 1 other identifier: 2934P
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

One of the limiting factors in the execution of a liver resection, in particular an extended liver resection, it's represented by the future remnant liver (FRL) after hepatic surgery. In cases of normal organ function an FRL of 25% is considered sufficient. In case of impaired hepatic function or a history of chemotherapy, it is considered safe if at least of 40%. Many strategies have been developed and proposed to increase the resectability in patients undergoing major liver resections. One of these is a new two-stage technique proposed recently by a group of German surgeons. This approach consists in the ligation of the right portal vein associated with resection of the liver along the falciform ligament (step 1). Step 2, after a period of 9 days (median - 5-25 days), after a volumetric CT to ensure an adeguate hypertrophy of the left lateral lobe due to the combination of right portal occlusion and segment 4 devascularization, the patient undergo a right trisectionectomy. The hypertrophy of the left lateral lobe is shown to be of 74%, higher than any other techniques of ligation or portal embolizatiol proposed in the literature. On the basis of the clinical experiences reported the investigators designed a new protocol of two-stage hepatic resection for the treatment of primary or secondary tumors of the right lobe. Step1: laparoscopic radio frequency / microwave ablation of the future transection plane between segment 4 and left lateral lobe and surgical ligation or embolization of the right portal vein. The ablation has the purpose to devascularize the segment 4 and has the same significance of the resection of the liver along the falciform ligament described by the Regensburg group. Step2: After a period of time of 9 ± 2 days, following a volumetric CT showing an adequate liver volume gain (ratio FRL / patient body weight\> 0.5), the patient undergo the second-stage surgery: laparoscopic/ laparotomic right trisectionectomy.

Conditions

Liver Tumors

Outcome Measures

Primary Outcomes (1)

• Percentage of R0 resections

  Percentage of operations in which a complete oncological radicality (R0) is achived

  30days after Step2

Secondary Outcomes (6)

• Perioperative mortality (3 months)

  3 moths

• Perioperative complication (Clavien Classification)

  1 month

• Time to progression

  12 months

• Overall survival

  12 and 24 months

• disease free survival

  12 months

Study Arms (1)

VLS ablation/portal ligation/hepatectomy

EXPERIMENTAL

Step1: * exploratory laparoscopy to exclude extrahepatic disease * right portal vein ligation if surgically feasible * RF/MW ablation on the future line of transection (of segment 4 close to left lateral lobe) * radiological portal embolization within 48h form the laparoscopic procedure if the right portal vein ligation is not feasible CT volumetric scan to evaluate the left lateral lobe hypertrophy after 9±2 from Step 1 Step 2: only if FRL/body weight \> 0.5 \- laparoscopic/laparotomic right trisectionectomy

Procedure: VLS ablation/portal ligation/hepatectomy

Interventions

VLS ablation/portal ligation/hepatectomy PROCEDURE

Step1: * exploratory laparoscopy to exclude extrahepatic disease * right portal vein ligation if surgically feasible * RF/MW ablation on the future line of transection (of segment 4 close to left lateral lobe) * radiological portal embolization within 48h form the laparoscopic procedure if the right portal vein ligation is not feasible CT volumetric scan to evaluate the left lateral lobe hypertrophy after 9±2 from Step 1 Step 2: only if FRL/body weight \> 0.5 \- laparoscopic/laparotomic right trisectionectomy

Also known as: VLS Ablation & Portal Vein Ligation for Staged Hepatectomy

VLS ablation/portal ligation/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 aged between 18 and 70 years (M and F)
• Liver tumors that interests the right hepatic lobe (segments 4,5,6,7,8) with possible involvement of the caudate lobe (segment 1) or bilobar disease with less than 3 lesions in the left lateral lobe without vascular involvement and amenable to surgically resectable or ablation in the Step1.
• Absence of extrahepatic disease
• Normal hepatic function (total bilirubin \<3 mg / dL)
• Performance status: ECOG 0
• In case of liver cirrhosis MELD score \<9
• Patients without prior chemotherapy or with previous chemotherapy but with response disease
• Patients who give their consent to the intervention

You may not qualify if:

• CT Evidence of involvement of the major vessels in the future remnant liver
• Presence of more than 3 nodules in the left lateral lobe
• Presence of extrahepatic disease
• Severe hepatic impairment
• Age\> 70 years
• Previous liver surgery (prior liver resections)
• Patient receiving chemotherapy with documented disease progression

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

Study Sites (1)

Chirurgia Epatobiliare e Trapianto Epatico - Azienda Ospedaliera di Padova

Padua, Padova, 35100, Italy

RECRUITING

Related Publications (10)

• Schnitzbauer AA, Lang SA, Goessmann H, Nadalin S, Baumgart J, Farkas SA, Fichtner-Feigl S, Lorf T, Goralcyk A, Horbelt R, Kroemer A, Loss M, Rummele P, Scherer MN, Padberg W, Konigsrainer A, Lang H, Obed A, Schlitt HJ. Right portal vein ligation combined with in situ splitting induces rapid left lateral liver lobe hypertrophy enabling 2-staged extended right hepatic resection in small-for-size settings. Ann Surg. 2012 Mar;255(3):405-14. doi: 10.1097/SLA.0b013e31824856f5.

  PMID: 22330038 BACKGROUND

• Lang H, Sotiropoulos GC, Brokalaki EI, Radtke A, Frilling A, Molmenti EP, Malago M, Broelsch CE. Left hepatic trisectionectomy for hepatobiliary malignancies. J Am Coll Surg. 2006 Sep;203(3):311-21. doi: 10.1016/j.jamcollsurg.2006.05.290. Epub 2006 Jul 13.

  PMID: 16931303 BACKGROUND

• Jaeck D, Oussoultzoglou E, Rosso E, Greget M, Weber JC, Bachellier P. A two-stage hepatectomy procedure combined with portal vein embolization to achieve curative resection for initially unresectable multiple and bilobar colorectal liver metastases. Ann Surg. 2004 Dec;240(6):1037-49; discussion 1049-51. doi: 10.1097/01.sla.0000145965.86383.89.

  PMID: 15570209 BACKGROUND

• Farges O, Belghiti J, Kianmanesh R, Regimbeau JM, Santoro R, Vilgrain V, Denys A, Sauvanet A. Portal vein embolization before right hepatectomy: prospective clinical trial. Ann Surg. 2003 Feb;237(2):208-17. doi: 10.1097/01.SLA.0000048447.16651.7B.

  PMID: 12560779 BACKGROUND

• Tartter PI. The association of perioperative blood transfusion with colorectal cancer recurrence. Ann Surg. 1992 Dec;216(6):633-8. doi: 10.1097/00000658-199212000-00004.

  PMID: 1466616 BACKGROUND

• Donati M, Stavrou GA, Oldhafer KJ. Current position of ALPPS in the surgical landscape of CRLM treatment proposals. World J Gastroenterol. 2013 Oct 21;19(39):6548-54. doi: 10.3748/wjg.v19.i39.6548.

  PMID: 24151380 BACKGROUND

• Lang H, Sotiropoulos GC, Fruhauf NR, Domland M, Paul A, Kind EM, Malago M, Broelsch CE. Extended hepatectomy for intrahepatic cholangiocellular carcinoma (ICC): when is it worthwhile? Single center experience with 27 resections in 50 patients over a 5-year period. Ann Surg. 2005 Jan;241(1):134-43. doi: 10.1097/01.sla.0000149426.08580.a1.

  PMID: 15622001 BACKGROUND

• Are C, Iacovitti S, Prete F, Crafa FM. Feasibility of laparoscopic portal vein ligation prior to major hepatectomy. HPB (Oxford). 2008;10(4):229-33. doi: 10.1080/13651820802175261.

  PMID: 18806869 BACKGROUND

• de Santibanes E, Alvarez FA, Ardiles V. How to avoid postoperative liver failure: a novel method. World J Surg. 2012 Jan;36(1):125-8. doi: 10.1007/s00268-011-1331-0.

  PMID: 22045448 BACKGROUND

• van Lienden KP, Hoekstra LT, Bennink RJ, van Gulik TM. Intrahepatic left to right portoportal venous collateral vascular formation in patients undergoing right portal vein ligation. Cardiovasc Intervent Radiol. 2013 Dec;36(6):1572-1579. doi: 10.1007/s00270-013-0591-5. Epub 2013 Mar 13.

  PMID: 23483283 BACKGROUND

Related Links

• Online resource of Chirurgia Epatobiliare e Trapianto Epatico, Università degli Studi di Padova

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Umberto Cillo, MD PhD

  Azienda Ospedaliera di Padova

  STUDY CHAIR

Central Study Contacts

Umberto Cillo, MD, PhD

CONTACT

+390498211846; cillo@unipd.it

Enrico Gringeri, MD, PHD

CONTACT

+390498211846; enrico.gringeri@unipd.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: full professor of general surgery, MD, PhD

Study Record Dates

• First Submitted: June 23, 2014
• First Posted: July 9, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

IT (1)