Clinical trial · Interventional
Laparoscopic Microwave Ablation and Portal Vein Ligation for Staged Hepatectomy (LAPS)
Liver Resection After Portal Vein Ligation / Embolization and Transection Plane Devascularization With Radio Frequency / Microwave: Pilot Study on Primary and Secondary Liver Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Tumors | Liver Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VLS ablation/portal ligation/hepatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VLS ablation/portal ligation/hepatectomy
- description
- 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
- interventionNames
- Procedure: VLS ablation/portal ligation/hepatectomy
Primary outcomes (1)
- measure
- Percentage of R0 resections
- timeFrame
- 30days after Step2
- description
- Percentage of operations in which a complete oncological radicality (R0) is achived
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (10)
- BACKGROUNDSchnitzbauer 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
- BACKGROUNDLang 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
- BACKGROUNDJaeck 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
- BACKGROUNDFarges 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
- BACKGROUNDTartter 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
- BACKGROUNDDonati 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
- 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.