German Clinical Trials Register

Acronym/abbreviation of the study

RIPE

URL of the study

http://keine Internetseite vorhanden

Brief summary in lay language

Anastomotic leakage (= suture leaking) is a dreaded complication after surgery on the esophagus. This often occurs due to ischemia (= reduced blood supply) of the anastomotic region. There is still an urgent need for methods to prevent suture leaks, which can be devastating, causing septicemia, reoperation, or even the death of the patient. "Remote ischemic preconditioning" (RIPC) is a novel approach in which a short amount of hypoperfusion is given away from the target organ (e.g., intestine or liver) e.g. by inflating a blood pressure cuff on an arm for 5 minutes. As a result, bodily substances, which mediate a complex control loop that protects against damage from reduced blood flow to the target organ. Numerous studies have demonstrated this protective effect for RIPC in various organs (e.g., brain, heart, kidney, liver). The planned pilot study is the first study that will investigate whether RIPC reduces the risk for anastomotic leakage after resection for esophageal cancer. The goal of this study is to gain enough data to plan a larger, subsequent multicenter study. During the 90-day follow-up period, the following outcomes will be assessed: surgical complications, reinterventions, hospital stay, readmission. A positive study outcome would be of high patient and clinical relevance due to the serious effects of anastomotic leakage.

Brief summary in scientific language

"Remote ischemic preconditioning" (RIPC) is an innovative approach that differs from other preconditioning strategies in that the ischemic stimulus (by inflating a blood pressure cuff on one extremity) is performed remotely from the target organ. As a result, several cytokines, are released, which protect the target organ against ischemic damage via a complex control loop. RIPC induces the release of serotonin from platelets, which stimulates VEGF secretion, which in turn up-regulates the release of IL10 and Mmp8 in the target organs. There are already multiple studies demonstrating that RIPC attenuates ischemia-reperfusion injury in various organ systems. Gastrointestinal anastomoses are highly vulnerable to ischemic injury and therefore anastomotic leakage has often an ischemic genesis. To what extent RIPC after esophageal resection has a protective effect on the development of anastomotic leakage is still unclear. To test the feasibility (accrual rate) and in preparation for a large-scale multicenter RCT (randomized controlled trial), the pilot RCT described here was designed.