Gastric CancerNCT01073046
Gastric Decompression After Sub-total Gastrectomy
An observational study of Gastric Cancer, run by Catholic University, Italy at 1 site in Italy.
Trial summary
The purpose of this study is to test the utility of the nasogastric tube, which is used to decompress and as "guardian" of gastro-jejunal anastomosis, in patients undergoing distal subtotal gastrectomy for gastric cancer with reconstruction according to Billroth II or according Roux. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Naso-Gastric/Jejunal Tube
- Type of treatment
- Medical device
- How many people
- 276 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Jun 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be included, using a randomization list provided to each center, in one of two groups: 1. placement of a polyurethane nasogastric/jejunal tube, preferentially 12-14 Fr; 2. no feeding tube placement.
Who may be able to join
- All people subjected to subtotal gastrectomy for distal gastric adenocarcinoma.
Who cannot join
- People undergoing enteral nutrition through naso-jejunal tube
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Naso-gastric/Jejunal Tube Placement After Sub-total Gastrectomy. A Multicenter Prospective Randomized Trial
The purpose of this study is to test the utility of the nasogastric tube, which is used to decompress and as "guardian" of gastro-jejunal anastomosis, in patients undergoing distal subtotal gastrectomy for gastric cancer with reconstruction according to Billroth II or according Roux.
Read the detailed description
A silastic naso-gastric tube (Rusch® distributed by Teleflex Medical Srl) is used in the naso-gastric/jejunal tube group
- Conditions
- Gastric Cancer
- Being tested
- Naso-Gastric/Jejunal Tube
- Keywords
- Naso-Gastric/Jejunal Tube, Sub-total Gastrectomy, Gastric Cancer, Decompression, Discomfort, Complications
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naso-Gastric/Jejunal TubeDevice
Also called Rusch® distributed by Teleflex Medical Srl
Silastic Naso-Gastric/Jejunal Tube (Rusch® distributed by Teleflex Medical Srl)
| Study group | Role | What they receive |
|---|---|---|
| Place Naso-Gastric/Jejunal Tube Group | In this group a silastic naso-gastric/jejunal tube is placed (Rusch® distributed by Teleflex Medical Srl) Receives: Device: Naso-Gastric/Jejunal Tube | |
| No Naso-Gastric/Jejunal Tube Group | In this group a silastic naso-gastric/jejunal tube is not placed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of Naso-Gastric/Jejunal Tube on Postoperative complications
Measured: 2 years
Secondary outcomes (1)
Influence of Naso-Gastric/Jejunal Tube on Postoperative Patient's Comfort
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Research Group For Gastric Cancer - IRGGC
- Responsible party
- Principal investigator, Fausto Rosa, Catholic University, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073046
- Sponsor's protocol ID
- 1053222
- Status last verified
- Jan 2010
- First submitted
- 1 Feb 2010
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Pacelli F, Rosa F, Marrelli D, Morgagni P, Framarini M, Cristadoro L, Pedrazzani C, Casadei R, Cozzaglio L, Covino M, Donini A, Roviello F, de Manzoni G, Doglietto GB. Naso-gastric or naso-jejunal decompression after partial distal gastrectomy for gastric cancer. Final results of a multicenter prospective randomized trial. Gastric Cancer. 2014 Oct;17(4):725-32. doi: 10.1007/s10120-013-0319-x. Epub 2013 Nov 30.
PubMed 24292257
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naso-gastric/Jejunal Tube Placement After Sub-total Gastrectomy. A Multicenter Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01073046
- Acronym / sponsor ID
- 1053222
- Conditions
- Gastric Cancer
- Keywords
- Naso-Gastric/Jejunal Tube, Sub-total Gastrectomy, Gastric Cancer, Decompression, Discomfort, Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Catholic University, ItalyUniversity, hospital or other
- Collaborators
- Italian Research Group For Gastric Cancer - IRGGC
- Study start
- Jan 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Feb 2010 (estimated)
- 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.
The purpose of this study is to test the utility of the nasogastric tube, which is used to decompress and as "guardian" of gastro-jejunal anastomosis, in patients undergoing distal subtotal gastrectomy for gastric cancer with reconstruction according to Billroth II or according Roux.
Detailed description
A silastic naso-gastric tube (Rusch® distributed by Teleflex Medical Srl) is used in the naso-gastric/jejunal tube group
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Place Naso-Gastric/Jejunal Tube Group | – | Device: Naso-Gastric/Jejunal TubeIn this group a silastic naso-gastric/jejunal tube is placed (Rusch® distributed by Teleflex Medical Srl) |
| No Naso-Gastric/Jejunal Tube Group | – | –In this group a silastic naso-gastric/jejunal tube is not placed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be included, using a randomization list provided to each center, in one of two groups: 1. placement of a polyurethane nasogastric/jejunal tube, preferentially 12-14 Fr; 2. no feeding tube placement.
Key inclusion criteria (1 listed)
- All people subjected to subtotal gastrectomy for distal gastric adenocarcinoma.
Key exclusion criteria (1 listed)
- People undergoing enteral nutrition through naso-jejunal tube
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 |
|---|---|---|
| Naso-Gastric/Jejunal TubeAlso: Rusch® distributed by Teleflex Medical SrlSilastic Naso-Gastric/Jejunal Tube (Rusch® distributed by Teleflex Medical Srl) | Device | Place Naso-Gastric/Jejunal Tube Group |
Primary outcome
Influence of Naso-Gastric/Jejunal Tube on Postoperative complications
Time frame: 2 years
1 secondary outcome
Influence of Naso-Gastric/Jejunal Tube on Postoperative Patient's Comfort
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- Derived from this study: PubMed 24292257Pacelli F, Rosa F, Marrelli D, Morgagni P, Framarini M, Cristadoro L, Pedrazzani C, Casadei R, Cozzaglio L, Covino M, Donini A, Roviello F, de Manzoni G, Doglietto GB. Naso-gastric or naso-jejunal decompression after partial distal gastrectomy for gastric cancer. Final results of a multicenter prospective randomized trial. Gastric Cancer. 2014 Oct;17(4):725-32. doi: 10.1007/s10120-013-0319-x. Epub 2013 Nov 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Catholic University, Italy at 1 site in Italy.
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: finished, as of the sponsor's last update on 2 Aug 2012. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of Naso-Gastric/Jejunal Tube on Postoperative complications (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01073046, which also lists 1 linked publication.
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 2 Aug 2012.