Clinical trial NCT00797251: Anatomical Right Posterior Sectionectomy of the Liver by IOUS-Guided Finger Compression
Official title: A Novel Simple Technique for Performing Anatomical Right Posterior Sectionectomy of the Liver: the Ultrasound-Guided Finger Compression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Liver Metastases
Hepatocellular Carcinoma
Liver Malignancies
Keywords: Colorectal liver metastasis
hepatocellular carcinoma
liver surgery
intraoperative ultrasound
finger-compression
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population include patients with primary or secondary liver tumors in the right posterior section of the liver eligible to a right posterior sectionectomy as a primary surgical procedure.

Brief summary: The use of intraoperative ultrasound (IOUS) allows us to perform new conservative hepatectomies. The investigators previously reported the systematic subsegmentectomy by IOUS-guided finger compression for segments 2-3, which is currently applied for patients with hepatocellular carcinoma (HCC)on cirrhosis. The investigators herein describe a novel technique, which consists in the systematic right posterior sectionectomy by IOUS-guided finger compression.

Detailed description: A novel technique for the demarcation of the resection area by means of IOUS-guided finger compression to accomplish a right posterior sectionectomy is described. Dissection or encirclement of the sectional pedicles for resection area demarcation is thus avoided. Ten patients underwent this technique successfully without mortality or major morbidity. IOUS-guided finger compression of sectional portal pedicle feeding the right posterior section is a feasible, safe, and effective method.

Eligibility criteria: Inclusion Criteria:

* Patients with tumors at least at 1 cm distally to the bifurcation of the right portal vein (bifurcation of P5-8 and P6-7) eligible for right posterior sectionectomy, namely the anatomical removal of segment 6 and 7, were considered potential candidates to this procedure. Precisely, these criteria were adopted:

  * Patients with hepatocellular carcinoma (HCC) with infiltrative growing pattern in contact with P6-7;
  * Patients with any type of HCC in contact with P6-7 with distal bile duct dilation;
  * Patients with colorectal liver metastasis (CLM) in contact with P6-7.

Exclusion Criteria:

* Exclusion criteria for carrying out the herein described procedure was considered the presence of tumoral thrombosis in P6-7.

Primary outcomes:
measure: The primary outcome is the safety of the anatomical right posterior sectionectomy performed IOUS-guided finger compression.
timeFrame: 6 months
Secondary outcomes:
measure: The secondary outcome is the efficacy of the anatomical right posterior sectionectomy performed by IOUS-guided finger compression.
timeFrame: 1 year
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: University of Milan School of Medicine, IRCCS Istituto Clinico Humanitas
state: Milan
Study officials:
affiliation: University of Milan School of Medicine, IRCCS Istituto Clinico Humanitas
name: Guido Torzilli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torzilli G, Donadon M, Marconi M, Botea F, Palmisano A, Del Fabbro D, Procopio F, Montorsi M. Systematic extended right posterior sectionectomy: a safe and effective alternative to right hepatectomy. Ann Surg. 2008 Apr;247(4):603-11. doi: 10.1097/SLA.0b013e31816387d7.
citation: Torzilli G, Donadon M, Montorsi M. The surgical margin in liver resection for hepatocellular carcinoma: a real problem or not? Ann Surg. 2007 Oct;246(4):690-1; author reply 691-2. doi: 10.1097/SLA.0b013e318156e286. No abstract available.
citation: Torzilli G, Montorsi M, Del Fabbro D, Palmisano A, Donadon M, Makuuchi M. Ultrasonographically guided surgical approach to liver tumours involving the hepatic veins close to the caval confluence. Br J Surg. 2006 Oct;93(10):1238-46. doi: 10.1002/bjs.5321.
citation: Torzilli G, Montorsi M, Donadon M, Palmisano A, Del Fabbro D, Gambetti A, Olivari N, Makuuchi M. "Radical but conservative" is the main goal for ultrasonography-guided liver resection: prospective validation of this approach. J Am Coll Surg. 2005 Oct;201(4):517-28. doi: 10.1016/j.jamcollsurg.2005.04.026.
citation: Torzilli G, Makuuchi M. Ultrasound-guided finger compression in liver subsegmentectomy for hepatocellular carcinoma. Surg Endosc. 2004 Jan;18(1):136-9. doi: 10.1007/s00464-003-9024-x. Epub 2003 Nov 21.
citation: Takasaki K, Kobayashi S, Tanaka S, Saito A, Yamamoto M, Hanyu F. Highly anatomically systematized hepatic resection with Glissonean sheath code transection at the hepatic hilus. Int Surg. 1990 Apr-Jun;75(2):73-7.
citation: Launois B, Jamieson GG. The posterior intrahepatic approach for hepatectomy or removal of segments of the liver. Surg Gynecol Obstet. 1992 Feb;174(2):155-8.
citation: Makuuchi M, Hasegawa H, Yamazaki S. Ultrasonically guided subsegmentectomy. Surg Gynecol Obstet. 1985 Oct;161(4):346-50.