Laparo-endoscopic single site cholecystectomy versus standard laparoscopic cholecystectomy: results of a pilot randomized trial

Background

In recent years, new devices providing multiple channels have made the performance of laparoscopic cholecystectomy through a single access site not only feasible but much easier. The potential benefits of laparoendoscopic single-site (LESS) cholecystectomy may include scarless surgery, reduced postoperative pain, reduced postoperative length of stay, and improved postoperative quality of life. There are no comparative data between LESS cholecystectomy and standard laparoscopic cholecystectomy (LC) available at present with which to quantify these benefits.

Methods

This study was a prospective, randomized, dual-institutional pilot trial comparing LESS cholecystectomy with standard LC. The primary end point was postoperative quality of life, measured as length of hospital stay, postoperative pain, cosmetic results, and SF-36 questionnaire scores. Secondary end points included operative time, conversion to standard LC, difficulty of exposure, difficulty of dissection, and complication rate.

Results

No significant differences in postoperative lengths of stay were found in the two groups. Postoperative pain evaluation using a visual analogue scale showed significantly better outcomes in the standard LC arm on the same day of surgery (P = .041). No differences in postoperative pain were found at the next visual analogue scale evaluation or in the postoperative administration of pain-relieving medications. Cosmetic satisfaction was significantly higher in the LESS group at 1-month follow-up (mean, 94.5 ± 9.4% vs 86 ± 22.3%; median, 100% vs 90%; P = .025). Among the 8 scales of the SF-36 assessing patients' physical and mental health, scores on the Role Emotional scale were significantly better in the LESS group (mean, 80.05 ± 29.42 vs 68.33 ± 25.31; median, 100 vs 66.67; P < .0001).

Conclusions

In this pilot trial, LESS cholecystectomy resulted in similar lengths of stay and improved cosmetic results and SF-36 Role Emotional scores but performed less well on pain immediately after surgery. A larger multicenter trial is needed to confirm and further investigate these results.     

The V599E BRAF mutation is uncommon in biliary tract cancers.

Activating point mutations of the BRAF oncogene have been identified in several solid tumors, most commonly in cutaneous melanomas and papillary carcinomas of the thyroid. A specific point mutation--V599E--accounts for the overwhelming majority of these mutational events. We explored the frequency of the V599E BRAF mutation in biliary tract cancers. In all, 62 archival biliary tract cancers, including 15 gallbladder cancers, 15 extrahepatic, and 10 intrahepatic cholangiocarcinomas from the United States, and 22 gallbladder carcinomas from Chile were analyzed for the V599E mutation of the BRAF gene using three distinct methods: direct sequencing, a primer extension method (Mutector assay), and the highly sensitive quantitative Gap Ligase Chain Reaction. The common V599E mutation was not identified in any of the 62 biliary cancer samples using these three methods of detection. The V599E somatic mutation of the BRAF gene is absent in biliary tract cancers, at least in the two geographic populations (United States and Chile) examined. Activation of the RAS/RAF/MAP kinase pathway in biliary tract cancers is likely to be secondary to oncogenic RAS mutations, or due to mutations of the BRAF gene at nucleotide positions not explored in the current study.     

Continuous infusion idarubicin and oral busulfan as conditioning for patients with acute myeloid leukemia aged over 60 years undergoing autologous stem cell transplantation

There is growing interest in autologous stem cell transplantation (ASCT) for elderly patients with acute myeloid leukemia (AML). While mortality and toxicity from ASCT have been reduced, relapse rate is still high. In a prospective study, we investigated the feasibility of a new conditioning regimen consisting of high-dose idarubicin plus busulfan in AML patients aged over 60 years undergoing ASCT. A total of 14 patients (median age: 64 years) received 2 days continuous infusion of idarubicin at 20 mg/m2/day, followed by 3 days of oral busulfan (4 mg/kg/day) as conditioning. No case of transplant-related mortality occurred. The median number of days to neutrophil ( > 0.5 x 10(9)/l) and platelet ( > 20 x 10(9)/l) recovery was 11 and 12, respectively. Cardiac toxicity was absent, while 12 patients (86%) had grade 3-4 mucositis. After a median follow-up of 9 months from ASCT, nine of 14 patients are alive in continuous complete remission (CR), four have relapsed at 3, 6, 8 and 9 months, and one died in CR1 from gastric cancer. Our data demonstrate the feasibility of a conditioning regimen based on high-dose idarubicin plus busulfan in elderly AML patients. Results concerning reduction of relapse rate need confirmation in a larger series with longer follow-up.