Léon Bérard Cancer Center, Lyon, France.
Ann Surg. 2013 Jul;258(1):30-6. doi: 10.1097/SLA.0b013e3182854949.
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.
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.
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.
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).
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).
通过前瞻性随机对照试验评估在需要两阶段肝切除术的转移性结直肠癌患者中使用生物可吸收透明质酸/羧甲基纤维素膜（HA 膜）预防腹部和肝周粘连的可行性和疗效。
两阶段肝切除术为选择的患者提供了长期生存的可能性，这些患者的肝转移灶不能在一次手术中切除。然而，第一次手术后的粘连使得第二次手术更加困难。HA 膜可减少妇科和腹部手术中的粘连，但这是第一次在肝切除术中进行的试验。
54 名符合两阶段肝切除术条件的患者在第一次手术后结束时随机分为 HA 膜植入组（n = 41）或标准治疗组（n = 13）。HA 膜组中有 30 名患者和 11 名匹配良好的对照组进行了计划中的第二次肝切除术。
HA 膜的定位在所有患者中均可行，且不会增加与第一次肝切除术相关的并发症。在第二次肝切除术中，HA 膜组患者完全肝脏游离所需时间比对照组少 33%（中位数：50 与 75 分钟；主要终点）。HA 膜组患者的严重粘连发生率降低（31%为 3-4 级粘连，对照组为 55%），粘连严重程度也降低（17%为厚而富血管粘连，对照组为 46%）。对照组第二次肝切除术后并发症的患者比例较高（55%比 HA 膜组的 23%，P = 0.07）。
在第一次肝切除术后使用 4 个 HA 膜可减少肝转移患者两阶段肝切除术所需的粘连范围和严重程度，并有助于第二次肝切除术。需要更大规模的研究来证实这些发现。（NCT01262417）。
