Remote Ischemic Preconditioning (RIPC) versus sham-control for prevention of anastomotic leakage after resection for Esophageal cancer: a prospective, randomized controlled, triple-blind, clinical phase III monocenter trial

Remote Ischemic Preconditioning (RIPC) versus sham-control for prevention of anastomotic leakage after resection for Esophageal cancer: a prospective, randomized controlled, triple-blind, clinical phase III monocenter trial - RIPE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00018934

Enrollment

Registered

2019-10-28

Start date

2019-12-11

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C15.9 K91.83

Interventions

Group 1: Experimental Arm/ Study Intervention: In RIPC, a blood pressure cuff is placed around an arm immediately prior to surgery (after induction of anesthesia and before/ during incision/dissection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Persons meeting the following criteria may be included in the study: • Planned elective esophagus resection for esophageal cancer • Signed informed consent • Age =18 years

Exclusion criteria

Exclusion criteria: Persons meeting any of the following criteria cannot be included in the study: • Patients not able to give informed consent • Patients presenting with the following contraindications to the study intervention (RIPC): arterial occlusive disease (AOD), infections or wounds on the upper extremity, poorly controlled diabetes mellitus, or deep vein thrombosis of the upper extremity

Design outcomes

Primary

Measure	Time frame
The primary endpoint is anastomotic leakage within 90 days after surgery, which would also be the primary outcome measure for a subsequent confirmatory trial. Anastomotic leakage is defined according to the “International Consensus on Standardization of Data Collection for Complications Associated With Esophagectomy” published by the Esophagectomy Complications Consensus Group (ECCG). In line with the report on standardization of data collection for complications associated with esophagectomy, AL is defined as a full-thickness defect involving the esophagus, the anastomosis or the gastric conduit. In patients with clinical symptoms (pain, fever, elevated infectious parameters, tachycardia/hypotension), anastomotic leakage will be confirmed by endoscopic (esophagogastroduodenoscopy (EGD)) or radiologic (esophageal contrast study, computed tomography scan with esophageal contrast) investigations. Asymptomatic patients, will be evaluated on a routine basis by endoscopy on postoperative day (POD) 4 (+/-1). All endoscopists and radiologists will be blinded to the study intervention.	—

Measure

Time frame

The primary endpoint is anastomotic leakage within 90 days after surgery, which would also be the primary outcome measure for a subsequent confirmatory trial. Anastomotic leakage is defined according to the “International Consensus on Standardization of Data Collection for Complications Associated With Esophagectomy” published by the Esophagectomy Complications Consensus Group (ECCG). In line with the report on standardization of data collection for complications associated with esophagectomy, AL is defined as a full-thickness defect involving the esophagus, the anastomosis or the gastric conduit. In patients with clinical symptoms (pain, fever, elevated infectious parameters, tachycardia/hypotension), anastomotic leakage will be confirmed by endoscopic (esophagogastroduodenoscopy (EGD)) or radiologic (esophageal contrast study, computed tomography scan with esophageal contrast) investigations. Asymptomatic patients, will be evaluated on a routine basis by endoscopy on postoperative day (POD) 4 (+/-1). All endoscopists and radiologists will be blinded to the study intervention.

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Secondary

Measure	Time frame
Secondary endpoints are perioperative morbidity and mortality (Clavien-Dindo classification), conduit necrosis, chyle leak, recurrent nerve palsy (defined by the ECCG), need for/duration of re-interventions (endoluminal vacuum therapy, interventional drainage, re-operation), hospital/ICU stay and readmissions. Effects of RIPC on biomarkers of ischemia-reperfusion injury (serotonin, VEGF) and necrotic cell death (Hmgb1) will be measured in plasma before RIPC (t0), immediately after RIPC (t1), and at 3 hours after RIPC (t2) using ELISA.	—

Measure

Time frame

Secondary endpoints are perioperative morbidity and mortality (Clavien-Dindo classification), conduit necrosis, chyle leak, recurrent nerve palsy (defined by the ECCG), need for/duration of re-interventions (endoluminal vacuum therapy, interventional drainage, re-operation), hospital/ICU stay and readmissions. Effects of RIPC on biomarkers of ischemia-reperfusion injury (serotonin, VEGF) and necrotic cell death (Hmgb1) will be measured in plasma before RIPC (t0), immediately after RIPC (t1), and at 3 hours after RIPC (t2) using ELISA.

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Countries

Germany

Contacts

Public ContactJulia Hardt

Universität Heidelberg, Medizinische Fakultät Mannheim, Chirurgische Klinik

julia.hardt@umm.de0621-383-2225

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026