Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with Low-Dose Cisplatin and Doxorubicin in Gastric Peritoneal Metastasis.

BACKGROUND: Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel technique of intraperitoneal chemotherapy. First results obtained with PIPAC in patients with advanced peritoneal metastasis (PM) from gastric cancer (GC) are presented. METHODS: Retrospective analysis: Sixty PIPAC were applied in 24 consecutive patients with PM from GC. 67 % patients had previous surgery, and 79 % previous platinum-based systemic chemotherapy. Mean Peritoneal Carcinomatosis Index (PCI) of 16 ± 10 and 18/24 patients had signet-ring GC. Cisplatin 7.5 mg/m(2) and doxorubicin 1.5 mg/m(2) were given for 30 min at 37 °C and 12 mmHg at 6 week intervals. Outcome criteria were survival, adverse events, and histological tumor response. RESULTS: Median follow-up was 248 days (range 105-748), and median survival time was 15.4 months. Seventeen patients had repeated PIPAC, and objective tumor response was observed in 12 (12/24 = 50 %): no vital tumor cells = 6, major pathological response = 6, minor response = 3. Postoperative adverse events > CTCAE 2 were observed in 9 patients (9/24, 37.5 %). In 3/17 patients, a later PIPAC could not be performed due to non-access. Two patients (ECOG 3 and 4) died in the hospital due to disease progression. CONCLUSION: PIPAC with low-dose cisplatin and doxorubicin was safe and induced objective tumor regression in selected patients with PM from recurrent, platinum-resistant GC. First survival data are encouraging and justify further clinical studies in this indication.

Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study.

OBJECTIVE: Recurrent ovarian, fallopian or peritoneal cancer with peritoneal carcinomatosis (ROCPC) is resistant to systemic chemotherapy. We assessed the safety and activity of laparoscopic pressurized intraperitoneal aerosol chemotherapy (PIPAC) in women with this cancer. METHODS: In this open-label, single-arm phase 2 study, patients underwent 3 courses q 28-42 days of PIPAC with doxorubicin 1·5 mg/m(2) followed by cisplatin 7·5 mg/m(2). A pressure of 12 mm Hg and a temperature of 37 °C were applied for 30 min/course. The primary endpoint was the proportion of patients who had an objective tumor response (OTR) according to RECIST version 1.1 criteria. Analysis was by intention to treat. Secondary endpoints were tumor regression on histology, PC Index improvement on repeated video-laparoscopy, and quality of life measured with the EORTC QLQ-30 questionnaire. RESULTS: Sixty-four patients were enrolled. Laparoscopic non-access rate was 11/64 (17%). 53 patients were eligible for analyses. 33/53 (62%) patients had an OTR - three had a partial response and 30 patients had stable disease. Tumor regression on histology and PC Index improvement were observed in 26/34 (76%) and in 26/34 (76%) patients who underwent all 3 PIPACs. There were no treatment-related deaths. No grade 4 toxicity was observed. Grade 3 toxicities were trocar hernia (n=2), bowel obstruction (n=2), abdominal pain (n=2), hematoma (n=1), intraoperative bleeding (n=1), and cystitis with urosepsis (n=1). EORTC QLQ-30 global physical health scores, nausea/vomiting, appetite loss, diarrhea, and constipation improved during therapy. CONCLUSION: PIPAC is well tolerated and active in women with ROCPC and warrants further investigation in these patients.

Activity of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin and doxorubicin in women with recurrent, platinum-resistant ovarian cancer: preliminary clinical experience.

OBJECTIVE: To assess the activity of laparoscopic Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in women with recurrent, platinum-resistant ovarian cancer. METHODS: Prospective case series using repeated courses q 28-42 days of PIPAC containing cisplatin 7.5 mg/m(2) and doxorubicin 1.5 mg/m(2) at 12 mmHg and 37°C for 30 min. Objective tumor response was defined as tumor regression on histology and peritoneal carcinomatosis index (PCI) improvement on repeated video-laparoscopy. RESULTS: 34 PIPAC procedures were performed in 18 women, in 8 instances combined with cytoreductive surgery (CRS). Eight women had repeated PIPAC and objective tumor response was observed in 6 (complete remission: 1; partial remission: 2; stable disease: 3). Five adverse events WHO grade ≥ 2 were noted, 3 of them after combined CRS. No perioperative mortality occurred. Median follow-up was 192 days (min. 13-max. 639). Cumulative survival after 400 days was 62% and mean actuarial survival time was 442 days. In a multivariable regression analysis with objective tumor response (yes vs. no) as the dependent variable and PIPAC (1 vs.>1), patient age (<75 vs.≥75 years), serum CA-125 (<1000 vs.>1000 U/mL), and the presence of ascites (yes vs. no) as independent variables, PIPAC independently predicted objective tumor response. CONCLUSION: PIPAC has activity in women with recurrent, platinum-resistant ovarian cancer and should be investigated in prospective clinical trials.

Medical effectiveness and safety of conventional compared to laparoscopic incisional hernia repair: a systematic review.

BACKGROUND: Incisional hernias are a common complication following abdominal surgery and represent about 80% of all ventral hernia. In uncomplicated postoperative follow-up they develop in about 11% of cases and in up to 23% of cases with wound infections or other forms of wound complications. While conventional mesh repair has been the standard of care in the past, the use of laparoscopic surgery is increasing. It therefore remains uncertain which technique should be recommended as the standard of care. OBJECTIVES: To compare the medical effectiveness and safety of conventional mesh and laparoscopic incisional hernia repair. METHODS: A structured literature search of databases accessed through the German Institute of Medical Documentation and Information (DIMDI) was conducted. English and German literature published until August 2005 was included and their methodological quality assessed. RESULTS: The search identified 17 relevant publications and included 15 studies for final assessment. Among those were one meta-analysis, one randomized clinical trial (RCT) ,and 13 cohort studies. All studies suffered from significant methodological limitations, such as differences in baseline characteristics between treatment groups, small case numbers, and the lack of adjustment for relevant confounders. Overall, medical effectiveness and safety were similar for both surgical approaches. However, there was a trend towards lower recurrence rates, length of hospital stay, and postoperative pain as well as decreased complication rates for the laparoscopic repair in the majority of studies. The impact of the technique of mesh implantation and mesh fixation as well as the impact of certain patient-related factors was not systematically assessed in any of the studies. CONCLUSION: No conclusive differences could be identified between the operative techniques. There was, however, some evidence for a trend towards similar or slightly improved outcomes associated with the laparoscopic procedure. There remains an urgent need for high-quality prospective studies to evaluate this question conclusively.

Does an informative video before inguinal hernia surgical repair influence postoperative quality of life? Results of a prospective randomized study.

PURPOSE: Patients undergoing surgery can be impaired in several health-related quality of life areas. As a result, a modern and effective presentation of medical information before elective surgery is of great importance. Thorough preoperative education of the patient could possibly lead to an improvement of postoperative quality of life. MATERIALS AND METHODS: In a prospective randomized study we examined the influence of a preoperative informative video on the postoperative quality of life of patients undergoing elective surgery for inguinal hernia. Quality of life was assessed with a short form questionnaire (SF-36) preoperatively, on the first postoperative day and 3, 6, and 12 months after surgery. RESULTS: From January 2004 until January 2005, 100 patients were included in the study (video group n = 50 patients, control group n = 50 patients). Quality of life was measured higher in the video group soon after surgery and until 3 months afterwards. In the same group other aspects evaluated such as "global health" and "social role" showed higher values postoperatively and resumption of preoperative activities took place earlier. No difference was detectable 6 months after surgery. CONCLUSION: Informative video presents a modern and cost-effective method for the justified and detailed education of the patient about the several pre-, intra-, and postoperative steps of an elective groin hernia operation. The higher information level and the better conditions of surgical care, as the patients perceive these, lead to a better postoperative quality of life.

Submandibular ectopic thyroid gland.

Ectopic thyroid glands are generally a rare entity appearing mostly in the cervical midline (90% of the cases) and even more rarely in other anatomical sites (10%). We present the case of an ectopic submandibular thyroid gland. An 81-year-old woman was referred to our department with a history of right-sided submandibular swelling. Preoperative FNA revealed benign ectopic thyroid tissue. The patient was submitted to resection of the mass. Histological examination of the specimen confirmed the diagnosis. A substitution treatment with thyroxin was initiated postoperatively, as this was the only functional thyroid tissue. Review of the literature revealed 18 similar cases. Physicians should be aware of the possibility that a submandibular swelling could be an ectopic thyroid gland. This entity poses specific diagnostic and therapeutic difficulties. Thorough preoperative diagnostics and resection of the ectopic tissue guarantee a good outcome.

Quality of life after gastrectomy: Longmire's reconstruction alone compared with additional pouch reconstruction.

The optimal reconstruction protocol after total gastrectomy is still a matter of debate. Pouch reconstructions are developed to create a larger reservoir for food, to provide a barrier against intestinoesophageal reflux, and to lengthen the food transit time. Preservation of the duodenal passage should result in better physiologic regulation of the ingested food. Controlled randomized clinical studies must be conducted to assess the quality of life after gastrectomy and various types of reconstruction. In the present trial, which compared Longmire's reconstruction without a pouch and Longmire's reconstruction with a pouch of varying sizes, we evaluated the quality of life for 41 patients during the first postoperative year. The quality of life was examined by an EORTC questionnaire and an organ-specific module. There were no statistically proven benefits for pouch reconstruction in comparison with Longmire's reconstruction alone. Some benefits are shown for the large pouch but it was only a trend. This is especially so with regard to diarrhea and food consumption. A definitive answer to the question about the value of a pouch reconstruction after gastrectomy has not yet been attained. It is possible that there will be significant differences between reconstruction groups during the long-term follow-up.