Thromboprophylaxis in oesophageal cancer patients-a study protocol for a randomised, controlled trial (TOP-RCT).

BACKGROUND: The purpose of the study is to examine if prolonged thromboprophylaxis decreases the risk of thrombosis after intended curative surgery for oesophageal cancer. Study results are expected to inform a guideline for thromboprophylaxis after oesophageal cancer surgery. The perspective is to reduce morbidity and mortality in this critically ill patient group. Thrombosis is the second-most common cause of cancer death after the cancer itself. The risk of thrombosis depends on the cancer type, and upper gastrointestinal cancers are considered high risk. This risk is further increased when patients undergo surgery. However, only few studies have investigated the peri- and postoperative coagulation profile in oesophageal cancer patients. Due to this lack of knowledge, prophylaxis is currently restricted to 5000 IU (international units) low-molecular weight heparin daily from surgery until discharge from hospital (approximately 10 days), whereas patients with gastric cancer receive 30 days of treatment. The present study examines whether a 30-day treatment is superior and safe, compared with the current standard treatment. METHODS: The study is a randomised controlled trial. Inclusion is ongoing, and we aim to include 100 patients. Blood samples are drawn before and after surgery, and the coagulation is extensively examined. The primary endpoint is the difference in plasma levels of prothrombin fragment 1 + 2 (F1 + 2) 30 days after surgery between the intervention and the standard group. Furthermore, patients are examined with ultrasound to screen for asymptomatic venous thrombotic events (VTE). Secondary endpoints are incidence of bleeding, symptomatic and asymptomatic VTE and mortality 30 days 1 one year after surgery. DISCUSSION: The study will provide valuable information on the perioperative coagulation profile and VTE risk of oesophageal cancer patients. The study seeks to aid in optimising the postoperative thromboprophylaxis, and the perspective is to reduce morbidity and mortality in this at-risk patient population. TRIALS REGISTRATION: The trial was prospectively registered at the EU Clinical Trials Register with ID 2021-001335-24 on 30 June 2021 and at ClinicalTrials.gov with study identifier NCT05067153.

EndoFLIP evaluation of the pylorus during minimal invasive Ivor-Levis esophagectomy.

BACKGROUND/AIMS: During esophagectomy for malignancy, the anterior and posterior branches of the vagus nerve are transected in order to achieve surgical radicality. This leads to loss of central nervous system-control of the pylorus which may lead to delayed gastric emptying. We aimed to investigate the feasibility of the EndoFLIP technique for assessment of pyloric biomechanical properties in patients undergoing esophagectomy. METHODS: A feasibility study in six patients undergoing surgery was conducted. EndoFLIP measurements were carried out preoperative (Pre-op), after surgical resection (Post-op) and following prophylactic balloon dilatation of the pylorus (Post-dil). By measuring the cross-sectional area and pressure of the pylorus the pyloric compliance and the incremental pressure-strain elastic modulus (Ep) were calculated. RESULTS: Placing the catheter in the pyloric region was successfully achieved in all six patients. No complications were observed. Resection of the esophagus increased the incremental pyloric elastic modulus (Ep) from 0.59 ± 0.18 kPa to 0.99 ± 0.34 kPa (p = 0.03). After dilatation, the Ep was reduced to 0.53 ± 0.23 kPa (p = 0.04), which was close to Pre-op (p = 0.62). The pyloric compliance showed a similar pattern as that found for Ep. CONCLUSION: The EndoFLIP system holds promise for assessment of biomechanics of the pyloric region in patients undergoing esophagectomy for cancer.

Long-term outcome of peroral endoscopic myotomy for esophageal achalasia in patients with previous Heller myotomy.

BACKGROUND: Peroral endoscopic myotomy (POEM) is an emerging procedure in the treatment of esophageal achalasia, a primary motility disorder. However, the long-term outcome of POEM in patients, who have previously undergone a Heller myotomy, is unknown. METHODS: Using a local database, we identified patients with esophageal achalasia, who underwent POEM. We compared patients with a previous Heller myotomy to those, who had received none or only non-surgical therapy prior to the POEM procedure. We conducted follow-up examinations at 3, 12, and 24 months following the procedure. RESULTS: We included 66 consecutive patients undergoing POEM for achalasia, of which 14 (21.2 %) had undergone a prior Heller myotomy. In both groups, the preoperative Eckardt score was 7. Postoperatively, the non-Heller group experienced a more pronounced symptom relief at both 3-, 12-, and 24-month follow-up compared with the Heller group, and there was a tendency for the effect of POEM to reduce over time. We suggest that there is a correlation between preoperative measurements of gastroesophageal sphincter pressures and the chance of a successful POEM. CONCLUSIONS: POEM has a place in the treatment of esophageal achalasia in patients with a prior Heller myotomy and persistent symptoms as it is a safe procedure with acceptable long-term results.

More patients should undergo surgery after sigmoid volvulus.

AIM: To assess the outcome of patients treated conservatively vs surgically during their first admission for sigmoid volvulus. METHODS: We conducted a retrospective study of 61 patients admitted to Aarhus University Hospital in Denmark between 1996 and 2011 for their first incidence of sigmoid volvulus. The condition was diagnosed by radiography, sigmoidoscopy or surgery. Patients treated with surgery underwent either a sigmoid resection or a percutaneous endoscopic colostomy (PEC). Conservatively treated patients were managed without surgery. Data was recorded into a Microsoft Access database and calculations were performed with Microsoft Excel. Kaplan-Meier plotting and Mantel-Cox (log-rank) testing were performed using GraphPad Prism software. Mortality was defined as death within 30 d after intervention or surgery. RESULTS: Among the total 61 patients, 4 underwent emergency surgery, 55 underwent endoscopy, 1 experienced resolution of the volvulus after contrast enema, and 1 died without treatment because of large bowel perforation. Following emergency treatment, 28 patients underwent sigmoid resection (semi-elective n = 18; elective n = 10). Two patients who were unfit for surgery underwent PEC and both died, 1 after 36 d and the other after 9 mo, respectively. The remaining 26 patients were managed conservatively without sigmoid resection. Patients treated conservatively on their first admission had a poorer survival rate than patients treated surgically on their first admission (95%CI: 3.67-14.37, P = 0.036). Sixty-three percent of the 26 conservatively treated patients had not experienced a recurrence 3 mo after treatment, but that number dropped to 24% 2 years after treatment. Eight of the 14 patients with recurrence after conservative treatment had surgery with no 30-d mortality. CONCLUSION: Surgically-treated sigmoid volvulus patients had a higher long-term survival rate than conservatively managed patients, indicating a benefit of surgical resection or PEC insertion if feasible.