Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Eso-SPONGE® device

About this trial

This is an interventional prevention trial for Esophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

We 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.

Patients considered at high risk for AL must have at least one of the following risk factors:

American Society of Anesthesiologists Classification (ASA) score >2
Diabetes (insulin dependent or HbA1c ≥ 6.5%)
Chronic pulmonary disease (first second of forced expiration (FEV1)/Forced volume vital capacity (FVC) ratio ≤ 70%)
Heart failure (left ventricular ejection fraction (LVEF) <55%)
Preexisting cardiac arrhythmia (pacemaker or paroxysmal supraventricular tachyarrhythmia)
Chronic kidney disease stage 4-5 (glomerular filtration rate (GFR) < 30ml/min/1.73 m2)
Chronic liver disease with treated portal hypertension (porto-caval pressure gradient ≥5-≤10mmHg, including patients with transjugular intrahepatic portosystemic shunt (TIPS))
Previous radiotherapy or chemo-radiation ≥50Gray (Gy) (salvage esophagectomy)

Alternatively, patients must have at least two of the following risk factors:

Arteriosclerosis score 2 according to van Rossum et al.13 (aorta and coeliac axis)
Malnutrition (Body mass index (BMI) ≤ 18.5kg/m2)
Obesity (BMI ≥ 35kg/m2)
Heart failure with preserved ejection fraction (LVEF >55%)
Active or former smoking
Age > 65 years
World health Organisation (WHO)/Zubrodt score > 1
chronic kidney disease stage 2-3 (GFR 30-89 ml/min/1.73 m2)
chronic liver disease without portal hypertension (porto-caval pressure gradient ≤5mmHg)

Exclusion Criteria:

Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia.
Patients younger than 18 years
Patients undergoing esophagectomy for benign disease or for malignancy other than adenocarcinoma or squamous cell carcinoma
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)
Chronic liver disease with portal hypertension (porto-caval pressure gradient >10mmHg)
Distant organ metastasis (cM+)

Sites / Locations

University Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

minimally invasive esophagectomy with preemptive ENP

Standard minimally invasive esophagectomy

Arm 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.

Patients in the control group will undergo a standard minimally invasive transthoracic Ivor Lewis esophagectomy without preemptive ENP.

Outcomes

Primary Outcome Measures

Length of hospital stay until "fit-for-discharge" criteria are reached

The patients' oral/enteral nutritional requirements are met by oral intake of at least liquids with optional supplementary nutrition via jejunal feeding tube. The patient should have passed flatus. The patient does not require oxygen during mobilisation (short walk or climbing stairs) or at rest. Central venous catheters should be removed before discharge (unless present preoperatively). 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. All vital signs should be normal unless abnormal preoperatively. Inflammatory parameters (white cell count, C-reactive protein) should be trending down and close to normal. There should be adequate support after discharge (assistance by family, ambulatory nursing, or rehabilitation facility).

Secondary Outcome Measures

Postoperative Complications

Assessment of postoperative complications according to Clavien-Dindo

Postoperative Complications

Hospital readmissions

Postoperative Complications

Anastomotic stricture

Full Information

NCT ID

NCT04162860

First Posted

July 11, 2019

Last Updated

December 10, 2019

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT04162860

Brief Title

Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy

Official Title

Preemptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy - An International Multicenter Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 4, 2019 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophageal Cancer, Surgery--Complications, Leak, Anastomotic

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

minimally invasive esophagectomy with preemptive ENP

Arm Type

Experimental

Arm 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.

Arm Title

Standard minimally invasive esophagectomy

Arm Type

No Intervention

Arm Description

Patients in the control group will undergo a standard minimally invasive transthoracic Ivor Lewis esophagectomy without preemptive ENP.

Intervention Type

Device

Intervention Name(s)

Eso-SPONGE® device

Intervention 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.

Primary Outcome Measure Information:

Title

Length of hospital stay until "fit-for-discharge" criteria are reached

Description

The patients' oral/enteral nutritional requirements are met by oral intake of at least liquids with optional supplementary nutrition via jejunal feeding tube. The patient should have passed flatus. The patient does not require oxygen during mobilisation (short walk or climbing stairs) or at rest. Central venous catheters should be removed before discharge (unless present preoperatively). 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. All vital signs should be normal unless abnormal preoperatively. Inflammatory parameters (white cell count, C-reactive protein) should be trending down and close to normal. There should be adequate support after discharge (assistance by family, ambulatory nursing, or rehabilitation facility).

Time Frame

90-days postoperatively

Secondary Outcome Measure Information:

Title

Postoperative Complications

Description

Assessment of postoperative complications according to Clavien-Dindo

Time Frame

90-days postoperatively

Title

Postoperative Complications

Description

Hospital readmissions

Time Frame

90-days postoperatively

Title

Postoperative Complications

Description

Anastomotic stricture

Time Frame

90-days postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: We 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. Patients considered at high risk for AL must have at least one of the following risk factors: American Society of Anesthesiologists Classification (ASA) score >2 Diabetes (insulin dependent or HbA1c ≥ 6.5%) Chronic pulmonary disease (first second of forced expiration (FEV1)/Forced volume vital capacity (FVC) ratio ≤ 70%) Heart failure (left ventricular ejection fraction (LVEF) <55%) Preexisting cardiac arrhythmia (pacemaker or paroxysmal supraventricular tachyarrhythmia) Chronic kidney disease stage 4-5 (glomerular filtration rate (GFR) < 30ml/min/1.73 m2) Chronic liver disease with treated portal hypertension (porto-caval pressure gradient ≥5-≤10mmHg, including patients with transjugular intrahepatic portosystemic shunt (TIPS)) Previous radiotherapy or chemo-radiation ≥50Gray (Gy) (salvage esophagectomy) Alternatively, patients must have at least two of the following risk factors: Arteriosclerosis score 2 according to van Rossum et al.13 (aorta and coeliac axis) Malnutrition (Body mass index (BMI) ≤ 18.5kg/m2) Obesity (BMI ≥ 35kg/m2) Heart failure with preserved ejection fraction (LVEF >55%) Active or former smoking Age > 65 years World health Organisation (WHO)/Zubrodt score > 1 chronic kidney disease stage 2-3 (GFR 30-89 ml/min/1.73 m2) chronic liver disease without portal hypertension (porto-caval pressure gradient ≤5mmHg) Exclusion Criteria: Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia. Patients younger than 18 years Patients undergoing esophagectomy for benign disease or for malignancy other than adenocarcinoma or squamous cell carcinoma 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) Chronic liver disease with portal hypertension (porto-caval pressure gradient >10mmHg) Distant organ metastasis (cM+)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian A. Gutschow, MD

Phone

+41442559723

Email

christian.gutschow@usz.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Gutschow, MD

Organizational Affiliation

University of Zurich

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Zurich

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christian A. Gutschow, MD

Phone

+41 44 255 9723

Email

christian.gutschow@usz.ch

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34013139

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.

Results Reference

derived

Esophageal Cancer, Surgery--Complications, Leak, Anastomotic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial