Objective: To assess by prospective randomized controlled trial the feasibility and efficacy of using a bioresorbable hyaluronic acid/carboxymethylcellulose membrane (HA membrane) to prevent abdominal and perihepatic adhesions in metastatic colorectal cancer patients requiring 2-stage hepatectomy.
Background: Two-stage hepatectomy offers the possibility of long-term survival to selected patients whose liver metastases cannot be removed in a single procedure. However, the second operation is made more difficult by adhesions arising from the first. HA membrane reduces adhesions in gynecologic and abdominal surgery but this is the first trial in hepatectomy.
Methods: Fifty-four candidates for 2-stage hepatectomy were randomized at the end of the first procedure to implantation of HA membrane (n = 41) or standard management (n = 13). Thirty patients from the membrane arm and 11 well-matched controls underwent the planned second hepatectomy.
Results: Positioning of the HA membranes was feasible in all but one patient and did not increase complications associated with the first hepatectomy. At second hepatectomy, patients in the HA membrane arm required 33% less time than controls to achieve complete liver mobilization (median: 50 vs 75 minutes; primary endpoint). The risk of extensive adhesions was reduced in the HA membrane group (31% had grade 3–4 adhesions vs 55% in controls), as was adhesion severity (17% thick and hypervascular adhesions vs 46%). The proportion of patients with complications at second hepatectomy was higher in the control group (55% vs 23% in the HA membrane group, P = 0.07).
Conclusion: Use of 4 HA membranes at the end of first hepatectomy reduced the extent and severity of adhesions and facilitated the second hepatectomy in patients with liver metastases who required a 2-stage hepatectomy. A larger study to confirm these findings is warranted. (NCT01262417)
In a prospective randomized controlled phase II trial in colorectal cancer patients with liver metastases who required 2-stage hepatectomy, positioning of a bioresorbable hyaluronic acid/carboxymethylcellulose membrane (Seprafilm) at the end of the first hepatectomy was feasible, reduced the extent and severity of postoperative adhesions and facilitated the second procedure.
*Léon Bérard Cancer Center, Lyon
†D'estaing University Hospital, Clermont-Ferrand
‡Paoli Calmettes Institute, Marseille
§Val d'Aurelle Cancer Center, Montpellier
¶Lyon Sud University Hospital, Lyon
‖Bergonie Institute, Bordeaux, France.
Reprints: Michel Rivoire, MD, PhD, Léon Bérard Cancer Center, 28, Rue Laënnec, 69008 Lyon, France. E-mail: email@example.com.
Disclosure: This trial was funded by the French NCI (under PHRC grant 2007-A00987-46). The authors declare no conflicts of interest.