Anastomotic LeakNCT04292496
Anastomotic Leak Testing in Gastrectomy
A study testing Introperative leak testing in people with Anastomotic Leak and Gastric Cancer, run by Nanchong Central Hospital at 1 site in China.
Trial summary
Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anastomotic Leak, Gastric Cancer, Surgery
- What is being tested?
- Introperative leak testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 13 Mar 2023
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- resectable gastric carcinoma according to the eighth edition of the TNM (clinical stages I-III).
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- American Society of Anesthesiologists class of I-III.
Who cannot join
- Patients had distant metastasis.
- presence of obvious contraindications to surgery (e.g., liver and/or kidney function abnormalities).
- any participation in another clinical trial within the past 6 months.
- Previous chemotherapy or radiation therapy for any other malignancies.
- past history of gastric resection, gastric cancer-related complications, other malignancy diagnosed within the previous 5 years,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efifcacy and Safety of Anastomotic Leak Testing in Gastric Cancer: a Randomized Controlled Trial
Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group.
Read the detailed description
Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group. patients underwent total gastrectomy for gastric cancer, with esophagojejunostomy reconstruction.
- Conditions
- Anastomotic Leak, Gastric Cancer, Surgery, Testing, Reality, Gastroscopy
- Being tested
- Introperative leak testing
- Keywords
- Anastomotic leakage, Gastric cancer, Leakage testing, Total gastrectomy, Gastroscopy
- Medical subject headings
- Anastomotic Leak, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introperative leak testingProcedure or surgery
After anastomosis was completed. We test the integrity of anastomosis intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Intraperative leak testing group | Experimental | i) the integrity of the anastomosis can be directly observed under gastroscopy. ii) the distal of Roux limb was temporarily blocked, then the bowel of anastomosis was inflated by air, following 60 milliliter methylene blue. Receives: Procedure: Introperative leak testing |
| Non-intraoperative leak testing group | No intervention | Non intraoperative leak testing was performed intraoperatively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic leakage
all patients underwent upper gastrointestinal radiography after surgery for detecting the integrity of anastomosis. X-ray to detect the integrity of the anastomosis
Measured: 2 months
Secondary outcomes (1)
Postoperative surgical complications
Any surgical complication that occured postoperatively
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Sep 2018
- Primary completion2 Sep 2022
- Study completion13 Mar 2023
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 Anastomotic LeakStudies 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
- Investigator
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yunhong Tian, Nanchong Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292496
- Sponsor's protocol ID
- 2020001
- Status last verified
- Nov 2024
- First submitted
- 28 Feb 2020
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gao Z, Luo H, Ma L, Bai D, Qin X, Bautista M, Gong L, Peng Y, Hu J, Tian Y. Efficacy and safety of anastomotic leak testing in gastric cancer: a randomized controlled trial. Surg Endosc. 2023 Jul;37(7):5265-5273. doi: 10.1007/s00464-023-10025-w. Epub 2023 Mar 27.
PubMed 36971816
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efifcacy and Safety of Anastomotic Leak Testing in Gastric Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04292496
- Acronym / sponsor ID
- 2020001
- Conditions
- Anastomotic Leak, Gastric Cancer, Surgery, Testing, Reality, Gastroscopy
- Keywords
- Anastomotic leakage, Gastric cancer, Leakage testing, Total gastrectomy, Gastroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 3 Mar 2020 (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.
Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group.
Detailed description
Anastomotic leak after radical gastrectomy is a serious complication. Intraoperative leak testing was often used to assess the integrity of the anastomosis. However, the reliability, clinical benefits and safety of intraoperative leak testing are controversial. Our aim is to evaluate the effect and safety of intraoperative leak testing, and to compare the surgical complications of patients in intraoperative leak testing group with patients in non-intraoperative leak testing group. patients underwent total gastrectomy for gastric cancer, with esophagojejunostomy reconstruction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraperative leak testing group | Experimental | Procedure: Introperative leak testingi) the integrity of the anastomosis can be directly observed under gastroscopy. ii) the distal of Roux limb was temporarily blocked, then the bowel of anastomosis was inflated by air, following 60 milliliter methylene blue. |
| Non-intraoperative leak testing group | No intervention | –Non intraoperative leak testing was performed intraoperatively. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- resectable gastric carcinoma according to the eighth edition of the TNM (clinical stages I-III).
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- American Society of Anesthesiologists class of I-III.
Key exclusion criteria (5 listed)
- Patients had distant metastasis.
- presence of obvious contraindications to surgery (e.g., liver and/or kidney function abnormalities).
- any participation in another clinical trial within the past 6 months.
- Previous chemotherapy or radiation therapy for any other malignancies.
- past history of gastric resection, gastric cancer-related complications, other malignancy diagnosed within the previous 5 years,
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 |
|---|---|---|
| Introperative leak testingAfter anastomosis was completed. We test the integrity of anastomosis intraoperatively. | Procedure or surgery | Intraperative leak testing group |
Primary outcome
Anastomotic leakage
Time frame: 2 months
all patients underwent upper gastrointestinal radiography after surgery for detecting the integrity of anastomosis. X-ray to detect the integrity of the anastomosis
1 secondary outcome
Postoperative surgical complications
Time frame: 3 months
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 14 Nov 2024.
- Derived from this study: PubMed 36971816Gao Z, Luo H, Ma L, Bai D, Qin X, Bautista M, Gong L, Peng Y, Hu J, Tian Y. Efficacy and safety of anastomotic leak testing in gastric cancer: a randomized controlled trial. Surg Endosc. 2023 Jul;37(7):5265-5273. doi: 10.1007/s00464-023-10025-w. Epub 2023 Mar 27.
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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?
A study testing Introperative leak testing in people with Anastomotic Leak and Gastric Cancer, run by Nanchong Central Hospital at 1 site in China.
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 3 inclusion and 5 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 14 Nov 2024. 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 China. 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?
Anastomotic leakage (time frame: 2 months). 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 NCT04292496, 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 14 Nov 2024.