A Retrospective Study of Risk Factors for Symptomatic Anastomotic Leakage after Laparoscopic Anterior Resection of the Rectal Cancer without a Diverting Stoma

Background. Anastomotic leakage (AL) is a common and devastating postoperative issue for patients who have undergone anterior resection of rectal carcinoma and can lead to increased short-term morbidity and mortality. Moreover, it might be associated with a worse oncological prognosis of tumors. This study is aimed at exploring the risk factors for symptomatic AL after laparoscopic anterior resection (LAR) for rectal tumors without a preventive diverting stoma. Materials and Methods. This case control study retrospectively reviewed the data of 496 consecutive patients who underwent LAR of the rectum without a preventive diverting stoma at the Cancer Hospital, Chinese Academy of Medical Sciences between September 2016 and September 2017. All patients were divided into an AL group and a control group based on the occurrence of postoperative symptomatic AL. Factors regarding patient-related variables, operation-related variables, and tumor-related variables were collected and assessed between the two groups through univariate and multivariate logistic regression analyses to identify independent risk factors for AL. Results. In total, 18 (3.6%) patients developed postoperative symptomatic AL. Univariate analysis showed that a synchronous primary malignancy of the left hemicolon (P=0.047), intraoperative chemotherapy (P=0.003), and level of anastomosis (P=0.033) were significantly related with AL. Multivariate analysis was subsequently performed to adjust for confounding biases and confirmed that a synchronous primary malignancy of the left hemicolon (odds ratio (OR), 12.225; 95% confidence interval (CI), 1.764-84.702; P=0.011), intraoperative chemotherapy (OR, 3.931; 95% CI, 1.334-11.583; P=0.013), and level of anastomosis (OR, 3.224; 95% CI, 1.124-9.249; P=0.030) were independent risk factors for symptomatic AL for patients who received LAR for rectal neoplasms without a preventive diverting stoma. Conclusions. Synchronous primary malignancy of the left hemicolon, intraoperative chemotherapy, and a low anastomotic level can increase the risks of postoperative symptomatic AL after LAR of the rectum without a protective diverting stoma.

Systemic complications of the bidirectional intraoperative chemotherapy with intravenous ifosfamide and hyperthermic intraperitoneal chemotherapy (HIPEC) using cisplatin plus doxorubicin

BackgroundIfosfamide has recently used as the intravenous component of bidirectional intraoperative chemotherapy (BDIC) with hyperthermic intraperitoneal chemotherapy (HIPEC) using cisplatin plus doxorubicin. Little is known about the systemic toxicities of this BDIC regimen. Therefore, this study aimed to assess the toxicities of this treatment.MethodsA prospective, cohort study, of patients who underwent the BDIC using intravenous ifosfamide 1,300 mg/m2 and a HIPEC regimen of cisplatin 50 mg/m2 plus doxorubicin 15 mg/m2, at King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia. Incidences and severity of leukopenia, neutropenia, thrombocytopenia, and erythrocytopenia were assessed over 45 days after BDIC. Nephrotoxicity was assessed according to the RIFLE (Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease) classification system. Haemorrhagic cystitis was assessed by cystoscopy.ResultsA total of 18 patients were enrolled in the study. Grade 1 leukopenia developed in 11.1% of the patients, with 5.5% developed neutropenia. Thrombocytopenia developed in 61.1% of patients; it was grade 1 or 2 in most patients, but grade 3 in 1 (5.5%) patient. All patients developed erythrocytopenia after BDIC. Leukopenia, neutropenia, and thrombocytopenia resolved without treatment in all patients. Nephrotoxicity developed in 33.3% of the patients. One patient progressed to the End-stage kidney disease classification. No patient developed haemorrhagic cystitis.ConclusionsIntravenous ifosfamide combined with HIPEC using cisplatin plus doxorubicin yielded low rates of mild leukopenia. Mild thrombocytopenia was frequent, but severe suppression of platelets was uncommon. Nephrotoxicity developed in one-third of the patients, and haemorrhagic cystitis was absent.

Protocol of a prospective, monocentric phase I/II feasibility study investigating the safety of multimodality treatment with a combination of intraoperative chemotherapy and surgical resection in locally confined or borderline resectable pancreatic cancer: the combiCaRe study

IntroductionPancreatic cancer is a devastating disease with an exceptionally poor prognosis. Complete resection of the primary tumour followed by adjuvant chemotherapy is the current standard treatment for patients with resectable disease and the only curative treatment option. However, long-term survival remains rare. Tumour cell dissemination due to manipulation during surgery may increase the rate of future metastases and local recurrence, and perioperative chemotherapy might diminish local, distant and circulating minimal residual disease. Yet, safety and feasibility of systemic chemotherapeutic treatments during pancreatic cancer resection have to be evaluated in a first instance.Methods and analysisThis is a prospective, single-centre phase I/II feasibility study to investigate the safety and tolerability of a combination of intraoperative chemotherapy and surgical resection in pancreatic cancer. Forty patients with locally confined or borderline resectable pancreatic cancer, meeting all proposed criteria will be included. Participants will receive 400 mg/m2 calcium folinate over 2 hours and 2000 mg/m2 5-fluorouracil over 48 hours, started on the day before pancreatic surgery and thus continuing during surgery. Participants will be followed until 60 days after surgery. The primary endpoint is the 30-day overall complication rate according to the Clavien-Dindo classification. Secondary endpoints comprise toxicity and treatment associated complications. Patients receiving perioperative chemotherapy will be compared with a propensity score matched contemporary control group of 70 patients with pancreatic cancer receiving the standard treatment. This trial also contains an ancillary translational study to analyse disseminated tumour cells and effects of pharmacological interventions in pancreatic cancer.Ethics and disseminationCombiCaRe has been approved by the German Federal Institute for Drugs and Medical Devices (reference number 4042787) and the Medical Ethics Committee of Heidelberg University (reference number AFmo-269/2018). The results of this trial will be presented at national and international conferences and published in peer-reviewed journals.Trial registration numberGerman Clinical Trials Register (DRKS00015766).