Authorised Phase III and phase IV (Integrated) esophageal cancer

PERi-operative Selective Decontamination of the Digestive tract to prevent severe infectious complications after Esophagectomy: a Randomized multicenter clinical trial in patients with primary resectable esophageal carcinoma (cT1-4, N0-3, M0)

EU CTIS ID: 2023-504144-33-01

What this study is testing

To evaluate the effect of SDD on infectious complications after esophagectomy, focussed on the prevention of pneumonia

  • Phase III and phase IV (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • - Diagnosis of primary esophageal adenocarcinoma or squamous cell carcinoma (cT1b-4a,N0-3,M0) in the mid or distal esophagus or at the level of the gastro-esophageal junction scheduled for undergoing transthoracic esophagectomy with curative intent or for esophageal reconstruction with a gastric or jejunal interposition
  • - Age ≥ 18 years
  • - Able to give written informed consent

You likely can't join if

  • - Patients planned for rescue surgery
  • - Patients planned for colonic interposition
  • - Known or suspected pregnancy
  • - Patients who have undergone upper GI surgery within 30 days before randomization
  • - Unable to understand the study information, study instructions and give informed consent
  • - Patients enrolled in a trial that would interact with the intervention
See the full eligibility criteria
Who can join
  • - Diagnosis of primary esophageal adenocarcinoma or squamous cell carcinoma (cT1b-4a,N0-3,M0) in the mid or distal esophagus or at the level of the gastro-esophageal junction scheduled for undergoing transthoracic esophagectomy with curative intent or for esophageal reconstruction with a gastric or jejunal interposition
  • - Age ≥ 18 years
  • - Able to give written informed consent
What rules you out
  • - Patients planned for rescue surgery
  • - Patients planned for colonic interposition
  • - Known or suspected pregnancy
  • - Patients who have undergone upper GI surgery within 30 days before randomization
  • - Unable to understand the study information, study instructions and give informed consent
  • - Patients enrolled in a trial that would interact with the intervention
  • - Patients with a known allergy, sensitivity, or interaction to investigational medicinal product
  • - Patients undergoing CVVH
  • - Patients with the inability to swallow the SDD

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.