Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-04 @ 6:01 PM
Study NCT ID:
NCT04162860
Status:
UNKNOWN
Last Update Posted:
2019-12-13
First Post:
2019-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D057868', 'term': 'Anastomotic Leak'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-10', 'studyFirstSubmitDate': '2019-07-11', 'studyFirstSubmitQcDate': '2019-11-11', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay until "fit-for-discharge" criteria are reached', 'timeFrame': '90-days postoperatively', 'description': "* The patients' oral/enteral nutritional requirements are met by oral intake of at least liquids with optional supplementary nutrition via jejunal feeding tube.\n* The patient should have passed flatus.\n* The patient does not require oxygen during mobilisation (short walk or climbing stairs) or at rest.\n* Central venous catheters should be removed before discharge (unless present preoperatively).\n* Adequate analgesia at rest and during mobilisation (pain score \\<4 on a scale from 0 to 10) is achieved using both oral opioid and non-opioid analgesics.\n* All vital signs should be normal unless abnormal preoperatively.\n* Inflammatory parameters (white cell count, C-reactive protein) should be trending down and close to normal.\n* There should be adequate support after discharge (assistance by family, ambulatory nursing, or rehabilitation facility)."}], 'secondaryOutcomes': [{'measure': 'Postoperative Complications', 'timeFrame': '90-days postoperatively', 'description': 'Assessment of postoperative complications according to Clavien-Dindo'}, {'measure': 'Postoperative Complications', 'timeFrame': '90-days postoperatively', 'description': 'Hospital readmissions'}, {'measure': 'Postoperative Complications', 'timeFrame': '90-days postoperatively', 'description': 'Anastomotic stricture'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Cancer', 'Surgery--Complications', 'Leak, Anastomotic']}, 'referencesModule': {'references': [{'pmid': '34013139', 'type': 'DERIVED', 'citation': 'Muller PC, Vetter D, Kapp JR, Gubler C, Morell B, Raptis DA, Gutschow CA. Pre-Emptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy (the preSPONGE Trial): Study Protocol for a Multicenter Randomized Controlled Trial. Int J Surg Protoc. 2021 Mar 18;25(1):7-15. doi: 10.29337/ijsp.24.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the preSponge randomized controlled trial (RCT) will be to assess the potential protective effects of preemptive endoscopic negative pressure therapy (ENP) on postoperative morbidity in high-risk patients undergoing total minimally invasive transthoracic esophagectomy with gastric pull-up reconstruction and high intrathoracic anastomosis (thoracoscopic and laparoscopic Ivor Lewis esophagectomy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nWe will include adult patients (≥18 years of age) with resectable esophageal cancer (adenocarcinoma or squamous cell carcinoma) with high risk for anastomotic leakage (AL) who provided informed consent and are scheduled for minimally invasive transthoracic Ivor Lewis esophagectomy. Robotic-assisted procedures will also be included.\n\nPatients considered at high risk for AL must have at least one of the following risk factors:\n\n* American Society of Anesthesiologists Classification (ASA) score \\>2\n* Diabetes (insulin dependent or HbA1c ≥ 6.5%)\n* Chronic pulmonary disease (first second of forced expiration (FEV1)/Forced volume vital capacity (FVC) ratio ≤ 70%)\n* Heart failure (left ventricular ejection fraction (LVEF) \\<55%)\n* Preexisting cardiac arrhythmia (pacemaker or paroxysmal supraventricular tachyarrhythmia)\n* Chronic kidney disease stage 4-5 (glomerular filtration rate (GFR) \\< 30ml/min/1.73 m2)\n* Chronic liver disease with treated portal hypertension (porto-caval pressure gradient ≥5-≤10mmHg, including patients with transjugular intrahepatic portosystemic shunt (TIPS))\n* Previous radiotherapy or chemo-radiation ≥50Gray (Gy) (salvage esophagectomy)\n\nAlternatively, patients must have at least two of the following risk factors:\n\n* Arteriosclerosis score 2 according to van Rossum et al.13 (aorta and coeliac axis)\n* Malnutrition (Body mass index (BMI) ≤ 18.5kg/m2)\n* Obesity (BMI ≥ 35kg/m2)\n* Heart failure with preserved ejection fraction (LVEF \\>55%)\n* Active or former smoking\n* Age \\> 65 years\n* World health Organisation (WHO)/Zubrodt score \\> 1\n* chronic kidney disease stage 2-3 (GFR 30-89 ml/min/1.73 m2)\n* chronic liver disease without portal hypertension (porto-caval pressure gradient ≤5mmHg)\n\nExclusion Criteria:\n\n* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia.\n* Patients younger than 18 years\n* Patients undergoing esophagectomy for benign disease or for malignancy other than adenocarcinoma or squamous cell carcinoma\n* Patients scheduled for other technical variants of esophagectomy, such as open, hybrid, or transhiatal procedures (intraoperative conversions to open access surgery will not be excluded)\n* Chronic liver disease with portal hypertension (porto-caval pressure gradient \\>10mmHg)\n* Distant organ metastasis (cM+)'}, 'identificationModule': {'nctId': 'NCT04162860', 'briefTitle': 'Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Preemptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy - An International Multicenter Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2019-00562'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'minimally invasive esophagectomy with preemptive ENP', 'description': 'Patients will undergo a standard total minimally invasive transthoracic Ivor Lewis esophagectomy with preemptive ENP. After completion of the esophago-gastric anastomosis, an Eso-SPONGE® system will be inserted via an intraoperative gastroscopy. ENP will be carried out upon completion of the esophago-gastrostomy, but no later than 12 hours after the surgical intervention. Postoperatively, secretions are then continuously evacuated using a suction pump generating a negative pressure between 75 and 100 mmHg. ENP will remain for 4 days and will be monitored with clinical parameters.', 'interventionNames': ['Device: Eso-SPONGE® device']}, {'type': 'NO_INTERVENTION', 'label': 'Standard minimally invasive esophagectomy', 'description': 'Patients in the control group will undergo a standard minimally invasive transthoracic Ivor Lewis esophagectomy without preemptive ENP.'}], 'interventions': [{'name': 'Eso-SPONGE® device', 'type': 'DEVICE', 'description': 'Preemptive ENP therapy will be carried out with either an Eso-SPONGE® device system (Eso-SPONGE®, B. Braun Melsungen AG, Melsungen, Germany). Eso-SPONGE® consists of an open-pored polyurethane foam fitted to a gastric tube. Secretions are then continuously evacuated using a suction pump generating a negative pressure between 75 and 100 mmHg.', 'armGroupLabels': ['minimally invasive esophagectomy with preemptive ENP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Christian A. Gutschow, MD', 'role': 'CONTACT', 'email': 'christian.gutschow@usz.ch', 'phone': '+41 44 255 9723'}], 'facility': 'University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Christian A. Gutschow, MD', 'role': 'CONTACT', 'email': 'christian.gutschow@usz.ch', 'phone': '+41442559723'}], 'overallOfficials': [{'name': 'Christian Gutschow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Head of upper gastrointestinal unit', 'investigatorFullName': 'Christian Gutschow', 'investigatorAffiliation': 'University of Zurich'}}}}