Pleura; EffusionNCT07125248
Outcomes of a Single Chest Drain vs Two Drains
A study testing Bilateral chest tube placement and Single drain placement in people with Pleura; Effusion and Esophageal Adenocarcinoma, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
Esophagectomy is a major surgical procedure done for carcinoma of esophagus. Usually bilateral chest tubes are placed in surgery for prevention of fluid accumulation in chest. However such procedure limits patients mobility and increases severity of pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pleura; Effusion, Esophageal Adenocarcinoma, Esophageal Anastomotic Leak
- What is being tested?
- Bilateral chest tube placement and Single drain placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2025to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing open esophagectomy for carcinoma of esophagus
Who cannot join
- Non consenting individuals esophagectomy for benign disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Khyber teaching hospital
Peshawar, Khyberpukhtunkhwa, 25000
Saeed Sarwar, MBBS, +923420973863, saeedkmc2020@gmail.com
About this study
Official title: Outcomes of Transhiatal Drain Placement in Esophagectomy, a Randomised Control Trial
Esophagectomy is a major surgical procedure done for carcinoma of esophagus. Usually bilateral chest tubes are placed in surgery for prevention of fluid accumulation in chest. However such procedure limits patients mobility and increases severity of pain. recent studies suggest that a single drain can be safe and effective. our study aims to compare the results of two chest tubes vs one.
- Being tested
- Bilateral chest tube placement, Single drain placement
- Medical subject headings
- Pleural Effusion, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral chest tube placementProcedure or surgery
Bilateral chest tubes will be passed in this intervention group through intercostal spaces
Single drain placementProcedure or surgery
A single transhiatal drain will be placed in mediastinum in this group
| Study group | Role | What they receive |
|---|---|---|
| Bilateral chest drains group | Experimental | Participants in this group will have bilateral intercostal chest tubes placed during surgery. Receives: Procedure: Bilateral chest tube placement |
| Single drain group | Experimental | Paricipants in this group will have a single transhiatal drain placed in mediastinum that would be brought out through abdomen Receives: Procedure: Single drain placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest expansion
Chest expansion will be observed by chest xray postoperatively
Measured: On postoperative day 1 and day 3 .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start28 Feb 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleura; EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Saeed Sarwar, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125248
- Sponsor's protocol ID
- 190/DME/KM
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients data will be confidential
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Transhiatal Drain Placement in Esophagectomy, a Randomised Control Trial
- ClinicalTrials.gov ID
- NCT07125248
- Acronym / sponsor ID
- 190/DME/KM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Esophagectomy is a major surgical procedure done for carcinoma of esophagus. Usually bilateral chest tubes are placed in surgery for prevention of fluid accumulation in chest. However such procedure limits patients mobility and increases severity of pain. recent studies suggest that a single drain can be safe and effective. our study aims to compare the results of two chest tubes vs one.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral chest drains group | Experimental | Procedure: Bilateral chest tube placementParticipants in this group will have bilateral intercostal chest tubes placed during surgery. |
| Single drain group | Experimental | Procedure: Single drain placementParicipants in this group will have a single transhiatal drain placed in mediastinum that would be brought out through abdomen |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing open esophagectomy for carcinoma of esophagus
Key exclusion criteria (1 listed)
- Non consenting individuals esophagectomy for benign disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral chest tube placementBilateral chest tubes will be passed in this intervention group through intercostal spaces | Procedure or surgery | Bilateral chest drains group |
| Single drain placementA single transhiatal drain will be placed in mediastinum in this group | Procedure or surgery | Single drain group |
Primary outcome
Chest expansion
Time frame: On postoperative day 1 and day 3 .
Chest expansion will be observed by chest xray postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No. Patients data will be confidential
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral chest tube placement and Single drain placement in people with Pleura; Effusion and Esophageal Adenocarcinoma, run by Khyber Teaching Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saeed Sarwar, MBBS (+923420973863, saeedkmc2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chest expansion (time frame: On postoperative day 1 and day 3 .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.