Rehabilitation strategies following oesophagogastric and Hepatopancreaticobiliary cancer (ReStOre II): a protocol for a randomized controlled trial.

BACKGROUND: Curative treatment for upper gastrointestinal (UGI) and hepatopancreaticobiliary (HPB) cancers, involves complex surgical resection often in combination with neoadjuvant/adjuvant chemo/chemoradiotherapy. With advancing survival rates, there is an emergent cohort of UGI and HPB cancer survivors with physical and nutritional deficits, resultant from both the cancer and its treatments. Therefore, rehabilitation to counteract these impairments is required to maximise health related quality of life (HRQOL) in survivorship. The initial feasibility of a multidisciplinary rehabilitation programme for UGI survivors was established in the Rehabilitation Strategies following Oesophago-gastric Cancer (ReStOre) feasibility study and pilot randomised controlled trial (RCT). ReStOre II will now further investigate the efficacy of that programme as it applies to a wider cohort of UGI and HPB cancer survivors, namely survivors of cancer of the oesophagus, stomach, pancreas, and liver. METHODS: The ReStOre II RCT will compare a 12-week multidisciplinary rehabilitation programme of supervised and self-managed exercise, dietary counselling, and education to standard survivorship care in a cohort of UGI and HPB cancer survivors who are > 3-months post-oesophagectomy/ gastrectomy/ pancreaticoduodenectomy, or major liver resection. One hundred twenty participants (60 per study arm) will be recruited to establish a mean increase in the primary outcome (cardiorespiratory fitness) of 3.5 ml/min/kg with 90% power, 5% significance allowing for 20% drop out. Study outcomes of physical function, body composition, nutritional status, HRQOL, and fatigue will be measured at baseline (T0), post-intervention (T1), and 3-months follow-up (T2). At 1-year follow-up (T3), HRQOL alone will be measured. The impact of ReStOre II on well-being will be examined qualitatively with focus groups/interviews (T1, T2). Bio-samples will be collected from T0-T2 to establish a national UGI and HPB cancer survivorship biobank. The cost effectiveness of ReStOre II will also be analysed. DISCUSSION: This RCT will investigate the efficacy of a 12-week multidisciplinary rehabilitation programme for survivors of UGI and HPB cancer compared to standard survivorship care. If effective, ReStOre II will provide an exemplar model of rehabilitation for UGI and HPB cancer survivors. TRIAL REGISTRATION: The study is registered with ClinicalTrials.gov, registration number: NCT03958019, date registered: 21/05/2019.

A modified surgical approach of hepatopancreatoduodenectomy for advanced gallbladder cancer: Report of two cases and literature review.

Gallbladder cancer (GBC) is the most common cancer of the biliary tract, constituting 80%-95% of malignant biliary tract tumors. Surgical resection is currently regarded as the sole curative treatment for GBC. Hepatopancreatoduodenectomy (HPD) has been adopted to remove the advanced gallbladder tumor together with the infiltrated parts within the liver, lower biliary tract and the peripancreatic region of GBC patients. However, patients who underwent HPD were reported to have a distinctly higher postoperative morbidity (71.4%, ranging from 30.8% to 100%) and mortality (13.2%, ranging from 2.4% to 46.9%) than those given pancreatoduodenectomy (PD) alone. We present two patients with advanced GBC who underwent a modified surgical approach of HPD: PD with microwave ablation (MWA) of adjacent liver tissues and the technique of intraductal cooling of major bile ducts. No serious complications like bile leakage, pancreatic fistula, hemorrhage and organ dysfunction, etc. occurred in the two patients. They had a rapid recovery with postoperative hospital stay being 14 days. Application of this approach effectively eliminated tumor-infiltrated adjacent tissues, and maximally reduced the postoperative morbidity and mortality. This modified surgical method is secure and efficacious for the treatment of locally advanced GBC.