A randomized phase II study of full dose gemcitabine versus reduced dose gemcitabine and nab-paclitaxel in vulnerable patients with non-resectable pancreatic cancer (DPCG-01).

BACKGROUND: According to current evidence, the best treatment for fit patients with non-resectable pancreatic cancer (PC) is combination chemotherapy, whereas frail patients are recommended gemcitabine (Gem) monotherapy. Randomized controlled trials in colorectal cancer and a post-hoc analysis of gemcitabine and nab-paclitaxel (GemNab) in PC suggest, however, that reduced dose of combination chemotherapy may be feasible and more efficient compared to monotherapy in frail patients. The aim of this study is to investigate whether reduced dose GemNab is superior to full dose Gem in patients with resectable PC, who are not candidates for full dose combination chemotherapy in first line. METHODS: The Danish Pancreas Cancer Group (DPCG)-01 trial is a national multicenter prospective randomized phase II trial. A total of 100 patients in ECOG performance status 0-2 with non-resectable PC, not candidate for full dose combination chemotherapy in first line, but eligible for full dose Gem, will be included. Patients are randomized 1:1 to either full dose Gem or GemNab in 80% of recommended dose. The primary endpoint is progression-free survival. Secondary endpoints are overall survival, overall response rate, quality of life, toxicity and rate of hospitalizations during treatment. The correlation between blood inflammatory markers, including YKL-40 and IL-6, circulating tumor DNA, and tissue biomarkers of resistance to chemotherapy and outcome will be explored. Finally, the study will include measures of frailty (G8, modified G8, and chair-stand-test) to assess whether scoring would enable a personalized allocation to different treatments or indicates a possibility for interventions. DISCUSSION: Single-drug treatment with Gem has for frail patients with non-resectable PC been the main treatment option for more than thirty years, but the impact on outcome is modest. If improved results and sustained tolerability with reduced dose combination chemotherapy can be shown, this could change the future practice for this increasing group of patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05841420. Secondary Identifying No: N-20210068. EudraCT No: 2021-005067-52. PROTOCOL VERSION: 1.5, 16-MAY-2023.

[Seizures caused by subarachnoid haemorrhage in a pregnant woman].

This case report describes a pregnant woman of gestational week 37 + 2 days who was admitted to the hospital with first-time seizures. The patient was stabilized, and an acute caesarian section was performed due to the possible aetiology of eclampsia and the advanced gestational age. Because of the atypical clinical history and normal maternal blood samples a computed tomography of the cerebrum was performed demonstrating a subarachnoid haemorrhage. A computed tomography-angiography revealed an aneurism at the anterior communicating artery. The aneurism was coiled the following day to reduce the risk of rebleeding.

[Treatment of acute cholecystitis in a third-trimester pregnant women]. / Behandling af akut kolecystitis hos gravide i tredje trimester.

This case report describes a 35-year-old female with acute cholecystitis 36 weeks into her pregnancy. Laparoscopic cholecystectomy was assessed not to be possible. An ultrasonic guided percutaneous transhepatic gall bladder drainage was performed resulting in immediate pain relief. The patient was discharged two days later, and the drain sat in place until a caesarian section was per--formed. A post-surgery cholangiography demonstrated stones in the gall bladder but no stones in the common bile duct. An uneventful laparoscopic cholecystectomy was carried out three months after surgery. The case report demonstrates that percutaneous transhepatic gall bladder drainage is a safe procedure to be considered in women with cholecystitis in which cholecystectomy is not possible or assumed to be associated with an unacceptable high risk.

Incidence and treatment of postoperative voiding dysfunction after the tension-free vaginal tape procedure.

INTRODUCTION AND HYPOTHESIS: One of the most commonly experienced postoperative complications of the tension-free vaginal tape procedure (TVT) is voiding dysfunction (VD). The aim of this retrospective study was to evaluate our incidence of postoperative VD, our results after tape mobilisation, and whether demographic data could predict VD. METHODS: A total of 715 women underwent a TVT procedure without concomitant operative procedures. In the case of persisting VD transvaginal tape mobilisation was performed up to 3 weeks postoperatively. The vaginal incision was reopened and downward extraction with a clamp was performed. Demographic data were investigated to predict postoperative VD. RESULTS: A total of 28 patients (3.9%) experienced VD. Seventeen patients (2.4%) underwent transvaginal tape mobilisation an average of 11.6 days (range 2-21) after the primary TVT procedure. No complications were observed in connection with the mobilisation. Eleven patients (1.5%) performed clean intermittent catheterisation (CIC) for a period of more than 1 day, with an average of 14.4 days (range 3-63). After tape mobilisation 16 women (94%) were relieved of their voiding dysfunction and were continent. One woman was somewhat incontinent after the procedure. Age, parity and previous caesarean section did not predict VD. Previous incontinence surgery might predict VD. CONCLUSIONS: The incidence of VD after the TVT procedure requiring tape mobilisation was 2.4%. Relief of the VD was obtained after tape mobilisation in all patients. Tape mobilisation is a safe and effective treatment for postoperative VD.

Paraurethral leiomyoma in a postmenopausal woman: first European case.

Leiomyomas are benign tumors extending from smooth muscle cells and only few cases of paraurethral leiomyomas have been described in the literature. They are often seen in the reproductive age and around 50% of the cases are asymptomatic. We describe a 59-year-old woman with a solid mobile tumor below the symphysis revealed at a gynecological examination. Transvaginal ultrasound and MRI confirmed the tumor and excision of the paraurethral tumor was carried out. The histological examination showed a benign paraurethral leiomyoma. The postoperative period was characterized by urethral pain as well as vaginal leakage of urine.