Sunil Shenvi1, Rajesh Gupta2, Mandeep Kang3, Madhu Khullar4, Surinder Singh Rana5, Rajinder Singh6, Deepak Kumar Bhasin5. 1. Transplant Surgery Division, Department of Surgery, Medical University of South Carolina, Charleston, SC, USA. 2. Surgical Gastroenterology Division, Department of General Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India. Electronic address: rajsarakshi@yahoo.co.in. 3. Department of Radiodiagnosis and Imaging, Postgraduate Institute of Medical Education and Research, Chandigarh, India. 4. Department of Experimental Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India. 5. Department of Gastroenterology, Postgraduate Institute of Medical Education and Research, Chandigarh, India. 6. Surgical Gastroenterology Division, Department of General Surgery, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Abstract
BACKGROUND: The timing of surgery in patients not responding to percutaneous catheter drainage (PCD) in infected pancreatic necrosis remains challenging. MATERIALS AND METHODS: A randomized controlled trial was designed to establish the optimal timings of surgery following PCD in patients with infected pancreatic necrosis (IPN). Patients who did not improve by day 10 after PCD insertion were included in the present study and were randomized to group A (step-up approach as a bridge to surgery) or group B (step-up approach with intention to avoid surgery). Weekly inflammatory and nutritional markers were monitored in both groups (clinical trials. gov identifier NCT-01527084). RESULTS:From July 2011 to December 2012, 40 patients underwent treatment withPCD. The first 8 patients were randomized into two groups. The trial was stopped prematurely because of difficulty in accrual and poor progress. All subsequent patients were managed with step-up approach with the intention to avoid surgery. Of 35 patients, 24 patients were managed by PCD alone while 11 patients required surgery. In patients who did not require surgery; levels of serum high sensitivity C-reactive protein (hsCRP), interleukin-6(IL6) and prealbumin showed a falling trend. This group also had higher baseline albumin and higher albumin at 4 weeks. CONCLUSION: During the present study, randomization into surgery at a predetermined time in step-up approach was discontinued due to poor progress. Step-up approach with the intention to avoid surgery led to a success rate of 68.5%. The present study failed to predict the optimal timing of surgery after PCD. Patients who needed surgery were sicker at the time of admission, had higher incidence of organ failure, and spent more time in the ICU compared to patients who did not need surgery. In future, inflammatory and nutritional markers may be useful to identify patients who are unlikely to respond to PCD and may help determine the timing of surgery.
RCT Entities:
BACKGROUND: The timing of surgery in patients not responding to percutaneous catheter drainage (PCD) in infected pancreatic necrosis remains challenging. MATERIALS AND METHODS: A randomized controlled trial was designed to establish the optimal timings of surgery following PCD in patients with infected pancreatic necrosis (IPN). Patients who did not improve by day 10 after PCD insertion were included in the present study and were randomized to group A (step-up approach as a bridge to surgery) or group B (step-up approach with intention to avoid surgery). Weekly inflammatory and nutritional markers were monitored in both groups (clinical trials. gov identifier NCT-01527084). RESULTS: From July 2011 to December 2012, 40 patients underwent treatment with PCD. The first 8 patients were randomized into two groups. The trial was stopped prematurely because of difficulty in accrual and poor progress. All subsequent patients were managed with step-up approach with the intention to avoid surgery. Of 35 patients, 24 patients were managed by PCD alone while 11 patients required surgery. In patients who did not require surgery; levels of serum high sensitivity C-reactive protein (hsCRP), interleukin-6(IL6) and prealbumin showed a falling trend. This group also had higher baseline albumin and higher albumin at 4 weeks. CONCLUSION: During the present study, randomization into surgery at a predetermined time in step-up approach was discontinued due to poor progress. Step-up approach with the intention to avoid surgery led to a success rate of 68.5%. The present study failed to predict the optimal timing of surgery after PCD. Patients who needed surgery were sicker at the time of admission, had higher incidence of organ failure, and spent more time in the ICU compared to patients who did not need surgery. In future, inflammatory and nutritional markers may be useful to identify patients who are unlikely to respond to PCD and may help determine the timing of surgery.
Authors: Eduardo J Houghton; Alain A García Vázquez; Manuel E Zeledón; Andrea Andreacchio; Gabriel Ruiz; Mariano Palermo; Mariano E Gimenez Journal: Arq Bras Cir Dig Date: 2018-07-02