Randomized clinical trial of psychological support and sleep adjuvant measures for postoperative sleep disturbance in patients undergoing oesophagectomy.

BACKGROUND: Major surgery such as oesophagectomy requires a postoperative stay in intensive care. Painful stimuli lead to sleep disturbance and impairment in quality of life. The aim of this study was to evaluate the effect of psychological counselling and sleep adjuvant measures on postoperative quality of sleep and quality of life. METHODS: This RCT was performed between January 2013 and October 2015. Patients undergoing oesophagectomy for cancer were randomized into one of four groups receiving: psychological counselling plus sleep adjuvant measures during the ICU stay; psychological counselling alone; sleep adjuvant measures alone during the ICU stay; or standard care. The primary endpoint was impairment in quality of life measured using the European Organisation for Research and Treatment of Cancer C30-QL2 questionnaire between admission for surgery and discharge from hospital. The secondary endpoint was impairment in quality of sleep assessed by means of the Pittsburgh Sleep Quality Index between admission for surgery and hospital discharge. RESULTS: The local ethics committee approved the early termination of the study because of relevant changes in the ICU setting. Some 87 patients were randomized and 74 patients were evaluated in the analysis. Psychological counselling reduced the impairment in quality of life (odds ratio 0·23, 95 per cent c.i. 0·09 to 0·61) and in quality of sleep (odds ratio 0·27, 0·10 to 0·73). CONCLUSION: Perioperative psychological support reduces impairment in quality of life and quality of sleep after oesophagectomy. Registration number: NCT01738620 (http://www.clinicaltrials.gov).

Hybrid minimally invasive esophagectomy for cancer: impact on postoperative inflammatory and nutritional status.

The purpose of this case-control study was to evaluate the impact of hybrid minimally invasive esophagectomy for cancer on surgical stress response and nutritional status. All 34 consecutive patients undergoing hybrid minimally invasive esophagectomy for cancer at our surgical unit between 2008 and 2013 were retrospectively compared with 34 patients undergoing esophagectomy with open gastric tubulization (open), matched for neoadjuvant therapy, pathological stage, gender and age. Demographic data, tumor features and postoperative course (including quality of life and systemic inflammatory and nutritional status) were compared. Postoperative course was similar in terms of complication rate. Length of stay in intensive care unit was shorter in patients undergoing hybrid minimally invasive esophagectomy (P = 0.002). In the first postoperative day, patients undergoing hybrid minimally invasive esophagectomy had lower C-reactive protein levels (P = 0.001) and white cell blood count (P = 0.05), and higher albumin serum level (P = 0.001). In this group, albumin remained higher also at third (P = 0.06) and seventh (P = 0.008) postoperative day, and C-reactive protein resulted lower at third post day (P = 0.04). Hybrid minimally invasive esophagectomy significantly improved the systemic inflammatory and catabolic response to surgical trauma, contributing to a shorter length of stay in intensive care unit.

Esophagectomy in elderly patients: which is the best prognostic score?

Our study aimed to identify the best prognostic score for fitness for surgery and postoperative morbidity in elderly patients. A prospectively collected database of a consecutive series of patients with esophageal cancer evaluated for possible esophagectomy at our unit was analyzed. Fitness for surgery and postoperative morbidity were used as measures of outcome. The performances of the Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity (POSSUM) score, the Charlson Comorbidity Index, the age-related Charlson Comorbidity Index (ACCI), the American Society of Anesthesiologists scale and the prognostic nutritional index (PNI) were evaluated in elderly patients. Discrimination was measured with receiver operating characteristics curve analysis; calibration was assessed by the Hosmer-Lemeshow goodness-of-fit test. Age did not result a significant predictor for postoperative complications. In elderly patients, ACCI predicted the judgment of the multidisciplinary team about fitness for surgery with the best discrimination (C-index = 0.94). PNI had the best discrimination for postoperative complications (C-index = 0.71) in the elderly group. ACCI best predicted the fitness for surgery in elderly patients. In elderly patients, the most discriminative prognostic score for postoperative complication was PNI, which could be used at admission for surgery to correctly inform patients about their risk and, possibly, to take extra precaution in case of high risk.

Impact of esophagectomy for cancer on patients' occupational status.

BACKGROUND: The aim of our study was to investigate the impact of esophagectomy for cancer on patients' occupational status. METHODS: All 109 consecutive patients presenting with esophageal cancer to the Surgical Oncology Unit of the Veneto Institute of Oncology Padua (Italy) between November 1, 2009 and March 15, 2012, were included in the study. Information on occupational status at diagnosis and at 1 year after esophagectomy was retrieved. Health-related quality of life was evaluated at discharge after surgery using selected aspects of the EORTC QLQ-C30 questionnaire. Non parametric statistics were used. RESULTS: Sixty-one patients (49.6%) were active workers at diagnosis and 50 of them (82.0%) underwent esophagectomy. Eighteen active workers (18/50, 36.0%) quit their job within one year from esophagectomy. They received jejunostomy more often than patients still working after surgery (50.0% vs. 18.8%, respectively; p = 0.03) and reported lower social functioning at discharge (mean ± SD 63.6 ± 16.4 vs. 80.2 ± 25.6 in others, p = 0.02). Multivariable analysis identified jejunostomy as independent predictor of job-quitting at 1 year after esophagectomy (p = 0.03; OR 4.75, 95% C.I. 1.11-20.39) but not social functioning at discharge (p = 0.21). CONCLUSIONS: Patients should be informed that they may experience social and work disability due to cancer treatment and adequate interventions of return-to-work support should be provided. Adequate welfare strategy should be implemented for esophageal cancer survivors, enhancing their role competences and contributing to precision care medicine.

Genetic risk of subsequent esophageal cancer in lymphoma and breast cancer long-term survival patients: a pilot study.

The occurrence of a second primary esophageal carcinoma (EC) in long-term cancer survivors may represent a late effect of previous radio-chemotherapeutic treatment. To identify the genetic factors that could increase this risk, we analyzed nine variants within ERCC1, XPD, XRCC1 and XRCC3 DNA repair pathway genes, and GSTP1, TP53 and MDM2 genes in 61 patients who received radio-chemotherapy for a prior lymphoma or breast cancer; 29 of them had a second primary EC. This cohort consists of 22 esophageal squamous cell carcinoma (ESCC) and 7 esophageal adenocarcinoma (EADC) patients. A validation cohort of 154 patients with sporadic EC was also included. The XPD Asp312Asn (rs1799793) was found to be associated with the risk of developing second primary ESCC (P=0.015). The resultant variant was also involved in the onset of sporadic ESCC (P=0.0018). To know in advance who among long-term cancer survivors have an increased risk of EC could lead to a more appropriate follow-up strategy.

Postoperative outcome after oesophagectomy for cancer: Nutritional status is the missing ring in the current prognostic scores.

BACKGROUND: Several prognostic scores were designed in order to estimate the risk of postoperative adverse events. None of them includes a component directly associated to the nutritional status. The aims of the study were the evaluation of performance of risk-adjusted models for early outcomes after oesophagectomy and to develop a score for severe complication prediction with special consideration regarding nutritional status. METHODS: A comparison of POSSUM and Charlson score and their derivates, ASA, Lagarde score and nutritional index (PNI) was performed on 167 patients undergoing oesophagectomy for cancer. A logistic regression model was also estimated to obtain a new prognostic score for severe morbidity prediction. RESULTS: Overall morbidity was 35.3% (59 cases), severe complications (grade III-V of Clavien-Dindo classification) occurred in 20 cases. Discrimination was poor for all the scores. Multivariable analysis identified pulse, connective tissue disease, PNI and potassium as independent predictors of severe morbidity. This model showed good discrimination and calibration. Internal validation using standard bootstrapping techniques confirmed the good performance. CONCLUSIONS: Nutrition could be an independent risk factor for major complications and a nutritional status coefficient could be included in current prognostic scores to improve risk estimation of major postoperative complications after oesophagectomy for cancer.

Complications after surgery for colorectal cancer affect quality of life and surgeon-patient relationship.

AIM: This multicentric prospective study aimed to investigate how postoperative complications after surgery for colorectal cancer affect patients' quality of life and satisfaction with care. METHOD: One hundred and sixteen patients operated on for colorectal cancer were enrolled in this study. Patients answered three questionnaires about generic (EORTC QLQ-C30) and disease-specific (EORTC QLQ-CR29) quality of life and treatment satisfaction (EORTC IN-PATSAT32) at the time of admission and at 1 and 6 months after surgery. Non-parametric tests and linear multiple regression models were used for statistical analysis. RESULTS: Twelve patients had complications requiring further surgery (anastomotic leakage, abdominal bleeding, abdominal wall sepsis, wound infection). Patients with complications that required surgery reported a worse score of physical function, emotional function and anxiety than patients without such complications 1 month after surgery. These patients judged their general satisfaction with the quality of care and doctors' interpersonal skills, technical skills, information provision and availability to be worse than in patients without such complications. The presence of postoperative psychiatric complications and anastomotic leakage were independent predictors of quality of life (ß = -0.30, P = 0.004, and ß = -0.42, P < 0.001). CONCLUSION: In patients undergoing surgery for colorectal cancer, complications requiring any kind of surgical management significantly affected patients' perception of all doctor-related items suggesting an impairment of the entire surgeon-patient relationship. Convincing patients that 'zero risk' cannot be achieved in surgical practice is therefore a priority.

Anastomotic stenoses occurring after circular stapling in esophageal cancer surgery.

BACKGROUND: Circular staplers have reduced the incidence of anastomotic leaks in esophagovisceral anastomosis. However, the prevalence of stenosis is greater with staplers than with manual suturing. The aim of this study was to analyze potential risk factors for the onset of anastomotic stenoses and to evaluate their treatment and final outcome. METHODS: Between 1990 and 1995, 187 patients underwent esophagectomy and esophagogastrostomy with anastomosis performed inside the chest using a circular stapler. RESULTS: Twenty-three patients (12.3%) developed an anastomotic stenosis. The incidence of strictures was inversely related to the diameter of the stapler. Concomitant cardiovascular diseases; morphofunctional disorders of the tubulized stomach, such as those related to duodenogastric reflux; and neoadjuvant chemotherapy were also recognized as significant risk factors. Endoscopic dilatations proved safe and were effective in the treatment of most anastomotic stenoses. CONCLUSIONS: To reduce the risk of anastomotic stenosis after stapled intrathoracic esophagogastrostomy, adequate vascularization of the viscera being anastomized should be maintained, and it is mandatory to use the largest circular stapler suitable. Furthermore, it is essential to reduce the negative inflammation-inducing effects of duodenogastroesophageal reflux to a minimum. Endoscopic dilatations are safe and effective in curing the great majority of anastomotic stenoses.

Intestinal metaplasia is the probable common precursor of adenocarcinoma in barrett esophagus and adenocarcinoma of the gastric cardia.

BACKGROUND: Intestinal metaplasia in the tubular esophagus is the recognized precancerous lesion of adenocarcinoma in Barrett esophagus. However, it is not yet clear whether adenocarcinoma of the gastric cardia arises from the same premalignant lesion, i.e., intestinal metaplasia of the gastric cardia. The purpose of this study was to compare adenocarcinomas in Barrett esophagus and adenocarcinomas of the gastric cardia at an early stage, when it was more likely that intestinal metaplasia had not been completely overgrown by the tumor. METHODS: The authors compared the epidemiologic, clinical, and pathologic features of early stage adenocarcinoma in Barrett esophagus and adenocarcinoma of the gastric cardia from 42 patients who underwent resection surgery. The presence of intestinal metaplasia was assessed in the resected specimens by using Alcian blue (pH 2.5) staining. RESULTS: Intestinal metaplasia was detected in the mucosa adjacent to neoplasia in 25 of 26 patients with adenocarcinoma in Barrett esophagus and in 11 of 16 (69%) patients with adenocarcinoma of the gastric cardia. Patient and tumor characteristics and survival were comparable in both groups. CONCLUSIONS: Intestinal metaplasia is a very common finding in the mucosa adjacent to early stage adenocarcinoma of the gastric cardia. Adenocarcinoma in Barrett esophagus and adenocarcinoma of the gastric cardia may represent the same disease; the former arises from longer segments of intestinal metaplasia and the latter from intestinal metaplasia of the cardia.

Chylothorax complicating esophagectomy for cancer: a plea for early thoracic duct ligation.

OBJECTIVE: Postoperative chylothorax remains an uncommon but potentially life-threatening complication of esophagectomy for cancer, and the ideal management is still controversial. The aim of the study was to compare the outcomes of patients treated nonoperatively with those of patients promptly undergoing reoperation. METHODS: From 1980 to 1998, 1787 esophagectomies for esophageal or cardia cancer were performed, and 19 (1.1%) patients had postoperative chylothorax. We analyzed type of operation, surgical approach, delay of diagnosis of chylothorax, daily chest tube output, type of management, major complications, death, hospital stay, and final outcome. RESULTS: Of the 19 patients with chylothorax, 11 were initially managed nonoperatively (group A): 4 (36%) patients had spontaneous resolution of chylothorax, and the other 7 required reoperation for the persistence of a high-volume output. There were three infectious complications and one postoperative death in this group. No reliable predictive criteria of successful versus unsuccessful nonoperative management could be found. The 8 most recent patients underwent early reoperation (group B). All patients recovered, and no major complications possibly related to chylothorax or hospital deaths were observed. They were discharged after a median of 22 days (range, 12-85 days) compared with a median of 36 days (range, 21-64 days) for patients of group A. CONCLUSIONS: Early thoracic duct ligation is the treatment of choice for chylothorax occurring after esophagectomy. Reoperation should be performed immediately after the diagnosis is made to avoid the complications related to nutritional and immunologic depletion caused by prolonged nonoperative treatment.

[First-line chemo-radiotherapy neoadjuvant treatment in locally advanced (T4) epidermoid carcinoma of the esophagus]. / Il trattamento neoadiuvante con chemio-radioterapia di prima linea nei carcinomi epidermoidi localmente avanzati (T4) dell'esofago.

In the period 1993-1997 we performed two phase II pilot studies of first-line chemo-radiotherapy in patients with locally advanced (T4) SCC of the esophagus. The first protocol (3 cycles of DDP-VP16 + 45 Gy) was used in 37 patients: toxicity was not negligible; a clinical tumor downstaging was obtained in 54% of cases; an R0 resection surgery was performed in 40% of patients. The overall median survival of the whole group of 37 patients was 11 months, while it was > 36 months for patients undergoing R0 resection. The second protocol (4 cycles of DDP-5FU + 45 Gy) was used in 25 patients: a clinical tumor downstaging was obtained in 55% of cases, and R0 resection surgery was performed in 45% of patients. The overall median survival of the whole group was 11 months. To date, all patients but one (who died after 13 months) are alive with a median follow up of 13 months. The prognosis of both groups of patients was improved compared to patients with T4 SCC of the esophagus who did not undergo chemo and/or radiotherapy. The survival advantage was especially evident for those who were able to undergo an R0 resection. First line chemo-radiotherapy should be considered the standard treatment for locally advanced esophageal SCC.

[Anastomotic stenoses correlated with the use of mechanical staplers in the surgery of esophageal cancer]. / Le stenosi anastomotiche correlate all'uso delle suturatrici meccaniche nella chirurgia del cancro dell'esofago.

From 1990 to 1995, 187 patients underwent esophagectomy and esophagogastrostomy with the anastomosis performed inside the chest using a circular stapler. Twenty-three patients (12.3%) developed an anastomotic stricture. The incidence of anastomotic stricture was inversely related to the diameter of the stapler. Also concomitant cardiovascular diseases, morpho-functional disorders of the tubulized stomach (possible related to duodeno-gastric reflux) and neoadjuvant chemotherapy were recognized as significant risks factors. Endoscopic dilations were safe and effective in the treatment of anastomotic strictures.