Esophageal CancerPhase 3NCT03273686
Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy
A Phase 3 study testing Discharge the NG tube during the surgery in people with Esophageal Cancer, run by Fudan University.
Trial summary
Nasogastric decompression is standard practice after esophageal resection in most centers because it is expected to reduce the incidence of esophagogastric anastomotic leakage by preventing overdistension of the gastric conduit. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Discharge the NG tube during the surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2017to 15 Apr 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who were fit for esophageal resection and underwent transthoracic or transhiatal esophagectomy with gastric tube reconstruction.
- -
Who cannot join
- Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b).
- Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.
- Patients with unstable situation after surgery (eg, need ventilation and ICU treatment)
- Patients medically unfit for surgical resection.
- Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
- Mentally disabled.
- Expected life duration of less than 3 months.
- Patients undergoing colonic reconstruction.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy: a Randomized Clinical Trial
Nasogastric decompression is standard practice after esophageal resection in most centers because it is expected to reduce the incidence of esophagogastric anastomotic leakage by preventing overdistension of the gastric conduit. Most esophageal surgeons have been reluctant to move away from this tradition because of the considerable morbidity of anastomotic leaks after esophagectomy. However, a contrarian view is that the use of prolonged NGD may increase the incidence of postoperative pulmonary complications by promoting aspiration. Considering the numerous complications caused by using the tube and the uncertainty about its usefulness and the scarcity of studies conducted on the subject, particularly in patients with esophageal cancer, the necessity of using the tube in these types of cases is investigated in the present study.
Read the detailed description
Methods In this clinical trial, patients with esophageal cancer were randomized into groups with NG tube and without NG tube after surgery. Sequence generation was performed using a computer-generated sequence of random numbers with permuted blocks. Standard postoperative management protocols were followed in both groups to avoid potential bias, which including preoperation nasogastric decompression. Thoracic esophageal mobilization and mediastinal lymphadenectomy were performed by open thoracotomy surgery. The abdominal part of the surgery was performed by laparotomy, gastric tube reconstruction was performed using linear staplers, and the conduit was brought up to the neck through the posterior mediastinal route. A cervical esophagogastric anastomosis was performed by stapled (linear) techniques. All patients were mobilized early, began early enteral feeding through jejunostomy tubes. Randomization was performed during the surgery. The group without NG tube after surgery will discharge the NG tube during the surgery. While the control group(group with NG tube after surgery) will discharge the NG tube 6-7days after surgery. The variables recorded for each patient included pulmonary complications, wound complications, anastomosis leak as well as the duration of postoperative hospitalization and the need for placing replacing the NG tube.
- Conditions
- Esophageal Cancer
- Being tested
- Discharge the NG tube during the surgery
- Keywords
- Esophageal Cancer, Nasogastric Tube
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge the NG tube during the surgeryProcedure or surgery
Discharge the NG tube during the surgery.
| Study group | Role | What they receive |
|---|---|---|
| group without NG tube after surgery | Experimental | In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube during the surgery. Receives: Procedure: Discharge the NG tube during the surgery |
| group with NG tube after surgery | No intervention | In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube 6-7 days after the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complication
the occurrence of major pulmonary complications and anastomotic leaks.
Measured: an expected average of 4 weeks
Secondary outcomes (2)
the need for placing/ replacing the NG tube
the need for placing/ replacing the NG tube
Measured: an expected average of 2 weeks
Length of postoperative stay
Length of postoperative stay
Measured: an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start15 Sep 2017 (estimated)
- Primary completion15 Jan 2018 (estimated)
- Study completion15 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiaqing Xiang, Fudan University
- Investigators
- Jiaqing Xiang, MD, Principal investigator, Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273686
- Sponsor's protocol ID
- ESO-NGT
- Status last verified
- Aug 2017
- First submitted
- 4 Sep 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nasogastric Tube Application in Postoperative Care of Esophagectomy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03273686
- Acronym / sponsor ID
- ESO-NGT
- Conditions
- Esophageal Cancer
- Keywords
- Esophageal Cancer, Nasogastric Tube
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Sep 2017 (estimated)
- Primary completion
- 15 Jan 2018 (estimated)
- Study completion
- 15 Apr 2018 (estimated)
- First posted
- 6 Sep 2017 (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.
Nasogastric decompression is standard practice after esophageal resection in most centers because it is expected to reduce the incidence of esophagogastric anastomotic leakage by preventing overdistension of the gastric conduit. Most esophageal surgeons have been reluctant to move away from this tradition because of the considerable morbidity of anastomotic leaks after esophagectomy. However, a contrarian view is that the use of prolonged NGD may increase the incidence of postoperative pulmonary complications by promoting aspiration. Considering the numerous complications caused by using the tube and the uncertainty about its usefulness and the scarcity of studies conducted on the subject, particularly in patients with esophageal cancer, the necessity of using the tube in these types of cases is investigated in the present study.
Detailed description
Methods In this clinical trial, patients with esophageal cancer were randomized into groups with NG tube and without NG tube after surgery. Sequence generation was performed using a computer-generated sequence of random numbers with permuted blocks. Standard postoperative management protocols were followed in both groups to avoid potential bias, which including preoperation nasogastric decompression. Thoracic esophageal mobilization and mediastinal lymphadenectomy were performed by open thoracotomy surgery. The abdominal part of the surgery was performed by laparotomy, gastric tube reconstruction was performed using linear staplers, and the conduit was brought up to the neck through the posterior mediastinal route. A cervical esophagogastric anastomosis was performed by stapled (linear) techniques. All patients were mobilized early, began early enteral feeding through jejunostomy tubes. Randomization was performed during the surgery. The group without NG tube after surgery will discharge the NG tube during the surgery. While the control group(group with NG tube after surgery) will discharge the NG tube 6-7days after surgery. The variables recorded for each patient included pulmonary complications, wound complications, anastomosis leak as well as the duration of postoperative hospitalization and the need for placing replacing the NG tube.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group without NG tube after surgery | Experimental | Procedure: Discharge the NG tube during the surgeryIn this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube during the surgery. |
| group with NG tube after surgery | No intervention | –In this goup, patients will undergo preoperative gastrointestinal decompression and investigators will discharge the NG tube 6-7 days after the surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who were fit for esophageal resection and underwent transthoracic or transhiatal esophagectomy with gastric tube reconstruction.
- -
Key exclusion criteria (8 listed)
- Stage investigations indicating unresectable advanced disease(T4 or M1a,M1b).
- Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment.
- Patients with unstable situation after surgery (eg, need ventilation and ICU treatment)
- Patients medically unfit for surgical resection.
- Patients with pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
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 |
|---|---|---|
| Discharge the NG tube during the surgeryDischarge the NG tube during the surgery. | Procedure or surgery | group without NG tube after surgery |
Primary outcome
postoperative complication
Time frame: an expected average of 4 weeks
the occurrence of major pulmonary complications and anastomotic leaks.
2 secondary outcomes
the need for placing/ replacing the NG tube
Time frame: an expected average of 2 weeks
Length of postoperative stay
Time frame: an expected average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jiaqing Xiang, MD principal investigator
Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Discharge the NG tube during the surgery in people with Esophageal Cancer, run by Fudan University.
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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiaqing Xiang, MD (+86 13901992249, j.q.xiang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complication (time frame: an expected average of 4 weeks). 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 6 Sep 2017.