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1.  Acute toxicity of definitive chemoradiation in patients with inoperable or irresectable esophageal carcinoma 
BMC Cancer  2014;14:56.
Background
Definitive chemoradiation (dCRT) is considered curative intent treatment for patients with inoperable or irresectable esophageal cancer. Acute toxicity data focussing on dCRT are lacking.
Methods
A retrospective analysis of patients treated with dCRT consisting of 6 cycles of paclitaxel 50 mg/m2 and carboplatin AUC2 concomitant with radiotherapy (50.4 Gy\1.8Gy) from 2006 through 2011 at a single tertiary center was performed. Toxicity, hospital admissions and survival were analysed.
Results
127 patients were treated with definitive chemoradiation. 33 patients were medically inoperable, 94 patients were irresectable, Despite of a significantly smaller tumor length in inoperable patients grade ≥3 toxicity was significantly recorded more often in the inoperable patients (44%) than in irresectable patients (20%) (p < 0.05) Hospital admission occurred more often in the inoperable patients (39%) than in the irresectable patients (22%) (p < 0.05) Median number of cycles of chemotherapy was five for inoperable patients (p = 0.01), while six cycles could be administered to patients with irresectable disease. Recurrence and survival were not significantly different. The odds ratio for developing toxicity ≥ grade 3 was 2.6 (95% CI 1.0-6.4 p < 0.05) for being an inoperable patient and 1.2 (95% CI 1.0-1.4 p = 0.02) per 10 extra micromol/l creatinine.
Conclusions
Our data show that acute toxicity of definitive chemoradiation is worse in patients with medically inoperable esophageal carcinoma compared to patients with irresectable esophageal cancer and mainly occurs in the 5th cycle of treatment. Improvement of supportive care should be undertaken in this more fragile group.
doi:10.1186/1471-2407-14-56
PMCID: PMC3922650  PMID: 24485047
Definitive chemoradiation; Esophageal cancer; Inoperable; Irresectable; Toxicity
2.  Chemotherapy followed by surgery versus surgery alone in patients with resectable oesophageal squamous cell carcinoma: Long-term results of a randomized controlled trial 
BMC Cancer  2011;11:181.
Background
This is a randomized, controlled trial of preoperative chemotherapy in patients undergoing surgery for oesophageal squamous cell carcinoma (OSCC). Patients were allocated to chemotherapy, consisting of 2-4 cycles of cisplatin and etoposide, followed by surgery (CS group) or surgery alone (S group). Initial results reported only in abstract form in 1997, demonstrated an advantage for overall survival in the CS group. The results of this trial have been updated and discussed in the timeframe in which this study was performed.
Methods
This trial recruited 169 patients with OSCC, 85 patients assigned to preoperative chemotherapy and 84 patients underwent immediate surgery. The primary study endpoint was overall survival (OS), secondary endpoints were disease free survival (DFS) and pattern of failure. Survival has been determined from Kaplan-Meier curves and treatment comparisons made with the log-rank test.
Results
There were 148 deaths, 71 in the CS and 77 in the S group. Median OS time was 16 months in the CS group compared with 12 months in the S group; 2-year survival rates were 42% and 30%; and 5-year survival rates were 26% and 17%, respectively. Intention to treat analysis showed a significant overall survival benefit for patients in the CS group (P = 0.03, by the log-rank test; hazard ratio [HR] 0.71; 95%CI 0.51-0.98). DFS (from landmark time of 6 months after date of randomisation) was also better in the CS-group than in the S group (P = 0.02, by the log-rank test; HR 0.72; 95%CI 0.52-1.0). No difference in failure pattern was observed between both treatment arms.
Conclusions
Preoperative chemotherapy with a combination of etoposide and cisplatin significantly improved overall survival in patients with OSCC.
doi:10.1186/1471-2407-11-181
PMCID: PMC3123658  PMID: 21595951
3.  Traditional invasive vs. minimally invasive esophagectomy: a multi-center, randomized trial (TIME-trial) 
BMC Surgery  2011;11:2.
Background
There is a rise in incidence of esophageal carcinoma due to increasing incidence of adenocarcinoma. Probably the only curative option to date is the use of neoadjuvant therapy followed by surgical resection. Traditional open esophageal resection is associated with a high morbidity and mortality rate. Furthermore, this approach involves long intensive care unit stay, in-hospital stay and long recovery period. Minimally invasive esophagectomy could reduce the morbidity and accelerate the post-operative recovery.
Methods/Design
Comparison between traditional open and minimally invasive esophagectomy in a multi-center, randomized trial. Patients with a resectable intrathoracic esophageal carcinoma, including the gastro-esophageal junction tumors (Siewert I) are eligible for inclusion. Prior thoracic surgery and cervical esophageal carcinoma are indications for exclusion. The surgical technique involves a right thoracotomy with lung blockade and laparotomy either with a cervical or thoracic anastomosis for the traditional group. The minimally invasive procedure involves a right thoracoscopy in prone position with a single lumen tube and laparoscopy either with a cervical or thoracic anastomosis. All patients in both groups will undergo identical pre-operative and post-operative protocol. Primary endpoint of this study are post-operative respiratory complications within the first two post-operative weeks confirmed by clinical, radiological and sputum culture data. Secondary endpoints are the operative data, the post-operative data and oncological data such as quality of the specimen and survival. Operative data include duration of the operation, blood loss and conversion to open procedure. Post-operative data include morbidity (major and minor), quality of life tests and hospital stay.
Based on current literature and the experience of all participating centers, an incidence of pulmonary complications for 57% in the traditional arm and 29% in the minimally invasive arm, it is estimated that per arm 48 patients are needed. This is based on a two-sided significance level (alpha) of 0.05 and a power of 0.80. Knowing that approximately 20% of the patients will be excluded, we will randomize 60 patients per arm.
Discussion
The TIME-trial is a prospective, multi-center, randomized study to define the role of minimally invasive esophageal resection in patients with resectable intrathoracic and junction esophageal cancer.
Trial registration (Netherlands Trial Register)
NTR2452
doi:10.1186/1471-2482-11-2
PMCID: PMC3031195  PMID: 21226918
4.  Hybrid NOTES transgastric cholecystectomy with reliable gastric closure: an animal survival study 
Surgical Endoscopy  2010;25(3):728-736.
Background
Secure transluminal closure remains the most fundamental barrier to safe translation of transgastric natural orifice transluminal endoscopic surgery (NOTES) procedures to humans. Obtaining optimal critical view of safety (CVS) is a prerequisite to performing cholecystectomy avoiding common bile duct injury.
Objectives
(1) To evaluate feasibility and safety of hybrid transgastric NOTES cholecystectomy. (2) To evaluate feasibility and reliability of gastrotomy closure using a novel Over-The-Scope-Clip (OTSC; Ovesco) in survival porcine experiments.
Methods
Laparoscopic access to the abdominal cavity was obtained by two 2-mm and one umbilical optical trocar(s). Gastric access was created by balloon dilatation of a needle knife puncture up to 18 mm. Exposure of CVS was obtained and evaluated by aid of a 2-mm device. Subsequently the cystic duct and artery were clipped endoscopically. After laparoscopic dissection the specimen was extracted via the stomach. The gastrotomy was closed endoscopically using the OTSC. Necropsy was performed after 10 days with inspection of gastrotomy and peritoneal cavity for complications. Experiments were planned in 3 acute and 16 survival pigs. Main outcome parameters were documented exposure of CVS, successful cholecystectomy and closure, uncomplicated survival and histology-confirmed full-thickness closure.
Results
In all 16 survival experiments CVS was obtained satisfactorily and hybrid cholecystectomy was successfully performed [100%; 95% confidence interval (CI): 81–100%]. Transgastric closure was endoscopically successful in all experiments in mean time of 7 min [standard deviation (SD) 3 min]. At necropsy 10 days after surgery there were no signs of (infectious) complications. Histology confirmed full-thickness healing with 100% success (95% CI: 81–100%).
Conclusion
Hybrid transgastric NOTES cholecystectomy is feasible, safe and results in optimal CVS. Use of OTSC for gastrotomy closure is feasible, reliable and results in histology-proven full-thickness closure in survival porcine experiments.
Electronic supplementary material
The online version of this article (doi:10.1007/s00464-010-1242-4) contains supplementary material, which is available to authorized users.
doi:10.1007/s00464-010-1242-4
PMCID: PMC3044824  PMID: 20721586
Therapeutic/palliation, endoscopy; G-I, endoscopy; Surgical, technical; Instruments, technical; Cholecystectomy; Digestive; Gastrointestinal perforations; Endoscopic closure; Critical view of safety
5.  Unique case of esophageal rupture after a fall from height 
Background
Traumatic ruptures of the esophagus are relatively rare. This condition is associated with high morbidity and mortality. Most traumatic ruptures occur after motor vehicle accidents.
Case Presentation
We describe a unique case of a 23 year old woman that presented at our trauma resuscitation room after a fall from 8 meters. During physical examination there were no clinical signs of life-threatening injuries. She did however have a massive amount of subcutaneous emphysema of the chest and neck and pneumomediastinum. Flexible laryngoscopy revealed a lesion in the upper esophagus just below the level of the upper esophageal sphincter. Despite preventive administration of intravenous antibiotics and nutrition via a nasogastric tube, the patient developed a cervical abscess, which drained spontaneously. Normal diet was gradually resumed after 2.5 weeks and the patient was discharged in a reasonable condition 3 weeks after the accident.
Conclusions
This case report presents a high cervical esophageal rupture without associated local injuries after a fall from height.
doi:10.1186/1471-227X-9-24
PMCID: PMC2801469  PMID: 20003506
6.  NEOadjuvant therapy monitoring with PET and CT in Esophageal Cancer (NEOPEC-trial) 
Background
Surgical resection is the preferred treatment of potentially curable esophageal cancer. To improve long term patient outcome, many institutes apply neoadjuvant chemoradiotherapy. In a large proportion of patients no response to chemoradiotherapy is achieved. These patients suffer from toxic and ineffective neoadjuvant treatment, while appropriate surgical therapy is delayed. For this reason a diagnostic test that allows for accurate prediction of tumor response early during chemoradiotherapy is of crucial importance. CT-scan and endoscopic ultrasound have limited accuracy in predicting histopathologic tumor response. Data suggest that metabolic changes in tumor tissue as measured by FDG-PET predict response better. This study aims to compare FDG-PET and CT-scan for the early prediction of non-response to preoperative chemoradiotherapy in patients with potentially curable esophageal cancer.
Methods/design
Prognostic accuracy study, embedded in a randomized multicenter Dutch trial comparing neoadjuvant chemoradiotherapy for 5 weeks followed by surgery versus surgery alone for esophageal cancer. This prognostic accuracy study is performed only in the neoadjuvant arm of the randomized trial. In 6 centers, 150 consecutive patients will be included over a 3 year period. FDG-PET and CT-scan will be performed before and 2 weeks after the start of the chemoradiotherapy. All patients complete the 5 weeks regimen of neoadjuvant chemoradiotherapy, regardless the test results. Pathological examination of the surgical resection specimen will be used as reference standard. Responders are defined as patients with < 10% viable residual tumor cells (Mandard-score).
Difference in accuracy (area under ROC curve) and negative predictive value between FDG-PET and CT-scan are primary endpoints. Furthermore, an economic evaluation will be performed, comparing survival and costs associated with the use of FDG-PET (or CT-scan) to predict tumor response with survival and costs of neoadjuvant chemoradiotherapy without prediction of response (reference strategy).
Discussion
The NEOPEC-trial could be the first sufficiently powered study that helps justify implementation of FDG-PET for response-monitoring in patients with esophageal cancer in clinical practice.
Trial registration
ISRCTN45750457
doi:10.1186/1756-6649-8-3
PMCID: PMC3301128  PMID: 18671847
7.  Total Laparoscopic Restorative Proctocolectomy: Are There Advantages Compared with the Open and Hand-Assisted Approaches? 
Diseases of the Colon and Rectum  2008;51(5):541-548.
Purpose
A randomized, controlled trial comparing hand-assisted laparoscopic restorative proctocolectomy with open surgery did not show an advantage for the laparoscopic approach. The trial was criticized because hand-assisted laparoscopic restorative proctocolectomy was not considered a true laparoscopic proctocolectomy. The objective of the present study was to assess whether total laparoscopic restorative proctocolectomy has advantages over hand-assisted laparoscopic restorative proctocolectomy with respect to early recovery.
Methods
Thirty-five patients underwent total laparoscopic restorative proctocolectomy and were compared to 60 patients from a previously conducted randomized, controlled trial comparing hand-assisted laparoscopic restorative proctocolectomy and open restorative proctocolectomy. End points included operating time, conversion rate, reoperation rate, hospital stay, morbidity, quality of life, and costs. The Medical Outcomes Study Short Form 36 and the Gastrointestinal Quality of Life Index were used to evaluate general and bowel-related quality of life.
Results
Groups were comparable for patient characteristics, such as sex, body mass index, preoperative disease duration, and age. There were neither conversions nor intraoperative complications. Median operating time was longer in the total laparoscopic compared with the hand-assisted laparoscopic group (298 vs. 214 minutes; P < 0.001). Morbidity and reoperation rates in the total laparoscopic, hand-assisted laparoscopic, and open groups were comparable (29 vs. 20 vs. 23 percent and 17 vs.10 vs. 13 percent, respectively). Median hospital-stay was 9 days in the total laparoscopic group compared with 10 days in the hand-assisted laparoscopic group and 11 days in the open group (P = not significant). There were no differences in quality of life and total costs.
Conclusions
There were no significant short-term benefits for total laparoscopic compared with hand-assisted laparoscopic restorative proctocolectomy with respect to early morbidity, operating time, quality of life, costs, and hospital stay.
doi:10.1007/s10350-007-9168-1
PMCID: PMC2365983  PMID: 18301949
Restorative proctocolectomy; Total laparosocpic; Hand-assisted laparoscopic; Ileal pouch-anal-anastomosis; Ulcerative colitis; Familial polyposis coli
8.  Preoperative and Early Postoperative Quality of Life Predict Survival in Potentially Curable Patients with Esophageal Cancer 
Annals of Surgical Oncology  2009;17(1):23-30.
Background
In patients with esophageal cancer, evidence for prognostic significance of preoperative quality of life (QoL) is limited, while the prognostic significance of postoperative QoL has not been investigated at all.
Aim
To determine whether preoperative and postoperative QoL measurements can predict survival independently from clinical and pathological factors, in patients with potentially curable esophageal adenocarcinoma.
Methods
A randomized controlled trial was performed from 1994 to 2000 in two academic medical centres, comparing transthoracic and transhiatal esophagectomy. QoL questionnaires were sent before and 3 months after surgery (Medical Outcome Study Short Form-20 and Rotterdam Symptom Checklist). Uni- and multivariate Cox regression analyses were used to examine firstly the prognostic value of preoperative QoL and several clinical factors, and secondly of postoperative QoL, several clinical factors, and pathological staging.
Results
Out of 220 randomized patients, 199 participated in the QoL-study. In the multivariate preoperative model physical symptom scale (p = 0.021), tumor length (p = 0.034), and endosonographic T-stage (p = 0.003) were predictive for overall survival. In the postoperative multivariate analysis, social functioning (p = 0.035), pain (p = 0.026), and activity level (p = 0.037) predicted survival, besides pathological T-stage (p < 0.001) and N-stage (p < 0.001).
Conclusion
In the present paper the first large consecutive series of potentially curable esophageal cancer patients is presented in whom prospectively collected QoL data before and after potentially curative surgical resection were used to predict survival. Both preoperative (physical symptoms) and postoperative (social functioning, pain, and activity level) QoL subscales are independent predictors of survival in potentially curable patients with esophageal adenocarcinoma.
doi:10.1245/s10434-009-0731-y
PMCID: PMC2805800  PMID: 19830496
9.  Perioperative strategy in colonic surgery; LAparoscopy and/or FAst track multimodal management versus standard care (LAFA trial) 
BMC Surgery  2006;6:16.
Background
Recent developments in large bowel surgery are the introduction of laparoscopic surgery and the implementation of multimodal fast track recovery programs. Both focus on a faster recovery and shorter hospital stay.
The randomized controlled multicenter LAFA-trial (LAparoscopy and/or FAst track multimodal management versus standard care) was conceived to determine whether laparoscopic surgery, fast track perioperative care or a combination of both is to be preferred over open surgery with standard care in patients having segmental colectomy for malignant disease.
Methods/design
The LAFA-trial is a double blinded, multicenter trial with a 2 × 2 balanced factorial design. Patients eligible for segmental colectomy for malignant colorectal disease i.e. right and left colectomy and anterior resection will be randomized to either open or laparoscopic colectomy, and to either standard care or the fast track program. This factorial design produces four treatment groups; open colectomy with standard care (a), open colectomy with fast track program (b), laparoscopic colectomy with standard care (c), and laparoscopic surgery with fast track program (d). Primary outcome parameter is postoperative hospital length of stay including readmission within 30 days. Secondary outcome parameters are quality of life two and four weeks after surgery, overall hospital costs, morbidity, patient satisfaction and readmission rate.
Based on a mean postoperative hospital stay of 9 +/- 2.5 days a group size of 400 patients (100 each arm) can reliably detect a minimum difference of 1 day between the four arms (alfa = 0.95, beta = 0.8). With 100 patients in each arm a difference of 10% in subscales of the Short Form 36 (SF-36) questionnaire and social functioning can be detected.
Discussion
The LAFA-trial is a randomized controlled multicenter trial that will provide evidence on the merits of fast track perioperative care and laparoscopic colorectal surgery in patients having segmental colectomy for malignant disease.
doi:10.1186/1471-2482-6-16
PMCID: PMC1693570  PMID: 17134506

Results 1-9 (9)