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Study on Preventing Infections After Esophageal Cancer Surgery Using Colistin Sulfate, Tobramycin, and Amphotericin B in Patients with Resectable Esophageal Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a treatment on patients with esophageal cancer, a type of cancer that occurs in the esophagus, the tube that carries food from the throat to the stomach. The treatment being tested is called “Basis voor SDD suspensie,” which is an oral suspension containing two active substances: colistin sulfate and tobramycin. Additionally, the study involves the use of amphotericin B, a medication that is mixed with the SDD suspension. These medications are being tested to see if they can help prevent severe infections, particularly pneumonia, after surgery to remove part of the esophagus, known as an esophagectomy.

The purpose of this study is to evaluate how effective the treatment is in reducing the risk of infections after esophagectomy. Participants in the study will receive the treatment for a period of up to seven days. The study will monitor the occurrence of infections, such as pneumonia, within 30 days after surgery. The trial will also look at other possible complications, including infections in different parts of the body, leakage at the surgical site, and overall recovery after surgery.

Throughout the study, researchers will collect information on the health and recovery of participants, including their quality of life and any additional surgeries or hospital stays needed. The study aims to provide valuable insights into improving the care and outcomes for patients undergoing surgery for esophageal cancer.

1 joining the study

Upon joining the study, the patient is required to provide written informed consent. This confirms understanding and agreement to participate in the trial.

2 pre-surgery medication

The patient will begin taking an oral suspension called Basis voor SDD suspensie, which contains the active substances colistin sulfate and tobramycin. This medication is administered to help prevent infections.

Additionally, the patient will take amphotericin B as an oral suspension. The specific dosage and frequency will be provided by the healthcare team.

3 surgery

The patient will undergo a transthoracic esophagectomy, a surgical procedure intended to remove esophageal cancer. This is performed with curative intent.

4 post-surgery monitoring

After surgery, the patient will be monitored for any signs of postoperative pneumonia and other infectious complications. This includes checking for symptoms such as fever, changes in white blood cell count, and purulent secretions.

The healthcare team will also monitor for anastomotic leakage, which may require further intervention if detected.

5 follow-up assessments

The patient will have follow-up assessments to evaluate the incidence of any postoperative complications within 30 days after surgery.

Quality of life will be assessed at 30 days, 3 months, and 6 months after surgery using specific questionnaires.

6 long-term monitoring

The patient will be monitored for all-cause mortality within 90 days after surgery.

The length of stay in the intensive care unit and the total hospital stay will be recorded, including any readmissions within 6 months after surgery.

7 cost evaluation

Direct and indirect costs related to the patient’s hospital stay and societal costs up to 6 months after surgery will be estimated using specific questionnaires.

Who Can Join the Study?

  • The patient must have a diagnosis of primary esophageal adenocarcinoma or squamous cell carcinoma. These are types of cancer found in the esophagus.
  • The cancer should be located in the mid or distal esophagus or at the level of the gastro-esophageal junction, which is where the esophagus meets the stomach.
  • The patient should be scheduled for a transthoracic esophagectomy, which is a surgery to remove part or all of the esophagus, with the aim of curing the cancer.
  • The patient may also be scheduled for esophageal reconstruction using a part of the stomach or small intestine.
  • The patient must be 18 years of age or older.
  • The patient must be able to give written informed consent, meaning they understand the study and agree to participate.

Who Cannot Join the Study?

  • Patients who are not diagnosed with esophageal cancer cannot participate. Esophageal cancer is a type of cancer that occurs in the esophagus, the tube that carries food from the mouth to the stomach.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Katholieke Universiteit te Leuven Leuven Belgium
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Medisch Centrum Leeuwarden B.V. Leeuwarden The Netherlands
Netherlands Cancer Institute Amsterdam The Netherlands
Universitair Ziekenhuis Gent Gent Belgium
Algemeen Ziekenhuis Delta Roeselare Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
Elisabeth-Tweesteden Ziekenhuis Tilburg The Netherlands
Soffbiujz Reqqdyr Upytcmhrwk Mzordph Cqlvoo Nijmegen The Netherlands
Eihlzlg Ulmaijstkcor Mosgosa Ckzcjqk Rnocuqksr (dxnqkmk Mzd Rotterdam The Netherlands
Uqygdxygxw Oz Arqkeol Edegem Belgium
Labnv Ufhkiehkykor Mkyjyjs Cuzgogl (islee Leiden The Netherlands
Uymkimjllder Mgtpfcf Clisiex Gjgabdnvr Groningen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
15.01.2024
The Netherlands The Netherlands
Recruiting
15.01.2024

Trial locations

Investigated drugs:

SDD (Selective Decontamination of the Digestive tract) is a treatment used in this trial to prevent severe infections, particularly pneumonia, after esophagectomy surgery. This therapy involves using specific antibiotics to reduce harmful bacteria in the digestive tract, aiming to lower the risk of infections that can occur after the surgical removal of part of the esophagus.

Esophageal Cancer – Esophageal cancer is a disease where malignant cells form in the tissues of the esophagus, the tube that carries food from the throat to the stomach. It often begins in the cells lining the inside of the esophagus and can grow to invade deeper layers and nearby structures. As the cancer progresses, it may cause symptoms such as difficulty swallowing, weight loss, and chest pain. The disease can spread to lymph nodes and other parts of the body, including the liver and lungs. The progression of esophageal cancer can vary, with some types growing more quickly than others.

Trial ID:
2023-504144-33-01
Protocol code:
114329
NCT ID:
NCT05865743
Trial Phase:
Human Pharmacology (Phase I) – Other

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