Peristaltic DirectionNCT04801459
Study on the Peristaltic Direction of GI Anastomosis in Roux-en-Y Reconstruction
A study testing Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction in people with Peristaltic Direction and Roux-en-Y Gastrointestinal Anastomosis, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The aim of this study is intending to provide the optimal procedures of the peristaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer, which can provide the best operation mode of Roux-en-Y anastomosis in digestive tract reconstruction during… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peristaltic Direction, Roux-en-Y Gastrointestinal Anastomosis, Gastric Cancer
- What is being tested?
- Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction
- 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
- 2 Apr 2021to 31 Mar 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Pathological examination confirmation the adenocarcinoma of stomach before surgery
- 2) Physical conditions compliance with the requirements for curative gastrectomy
- 3) Consent to undergo the D2 lymphadenectomy, and the dissected proportion of stomach no less than 2/3
- 4) Comply with the protocol during the whole study period
- 5) No neoadjuvant therapy administration
- 6) Sign informed consent and permission of withdraw in the whole study period
Show all 14Show fewer
- 7) Consent to provide the tissue specimens after surgery for this study
- 8) Estimation the overall survival after surgery no less than 6 months
- 9) No anesthesia or operation contraindication disease
- 10) cT1-4N0-2M0 stage demonstration by CT and endoscopic ultrasonography examinations
- 11) Negative cytological detection in operation
- 12) No seriously concomitance's diseases
- 13) Karnofsky Performance Scores (KPS) more than 60
- 14) Examined lymph node count no less than 16
Who cannot join
- 1) Women during pregnant stage and breast-feed stage
- 2) Women of childbearing age without any contraceptive measures
- 3) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
- 4) Immunosuppressive therapists for organ transplantation
- 5) Seriously uncontrolled recurrent infection
- 6) other malignant tumors
Show all 10Show fewer
- 7) No abilities of self-knowledge or mental disorders
- 8) Participating in other clinical trials
- 9) Siewert I and II esophagogastric junction tumors
- 10) Serious internal diseases obstruction surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Tianjin Medical University
Tianjin, 300060
Jingyu Deng, M.D.
About this study
Official title: A Single Center Randomized Prospective Study on the Peristaltic Direction of Gastrointestinal Anastomosis in Roux-en-Y Reconstruction After Distal Curative Gastrectomy for Gastric Cancer
The aim of this study is intending to provide the optimal procedures of the peristaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer, which can provide the best operation mode of Roux-en-Y anastomosis in digestive tract reconstruction during distal gastrectomy for reducing postoperative complications and improving quality of life for patients.
Read the detailed description
In this study, all 148 the included patients will underwent the distal curative gastrectomy for gastric cancer and will be performed the Roux-en-Y reconstruction for gastrointestinal anastomosis. Of them, 74 patients will be randomized in the group undergoing with the isoperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Meanwhile, the other 74 cases will be randomized in the group undergoing with the antiperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Then, we will evaluate the differencies of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.) and late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.) between above two group of patients, which will make an important contribution to reduce medical costs and potential improvements of the prognosis after distal curative gastrectomy for gastric cancer.
- Being tested
- Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstructionProcedure or surgery
In this study, intervention methods include two kind directions of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer. One is the isoperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was consistent. The other is the antiperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was opposite.
| Study group | Role | What they receive |
|---|---|---|
| Antiperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group | Experimental | The isoperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was consistent. Receives: Procedure: Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction |
| Isoperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group | Active comparator | The antiperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was opposite. Receives: Procedure: Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative recovery results
Differences of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.)
Measured: Within 1 month after surgery
Late postoperative recovery results
Differences of late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.)
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start2 Apr 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peristaltic DirectionStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801459
- Sponsor's protocol ID
- DJY002
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- 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 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Randomized Prospective Study on the Peristaltic Direction of Gastrointestinal Anastomosis in Roux-en-Y Reconstruction After Distal Curative Gastrectomy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT04801459
- Acronym / sponsor ID
- DJY002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 2 Apr 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 17 Mar 2021 (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.
The aim of this study is intending to provide the optimal procedures of the peristaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer, which can provide the best operation mode of Roux-en-Y anastomosis in digestive tract reconstruction during distal gastrectomy for reducing postoperative complications and improving quality of life for patients.
Detailed description
In this study, all 148 the included patients will underwent the distal curative gastrectomy for gastric cancer and will be performed the Roux-en-Y reconstruction for gastrointestinal anastomosis. Of them, 74 patients will be randomized in the group undergoing with the isoperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Meanwhile, the other 74 cases will be randomized in the group undergoing with the antiperistaltic anastomosis in the Roux-en-Y reconstruction procedure. Then, we will evaluate the differencies of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.) and late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.) between above two group of patients, which will make an important contribution to reduce medical costs and potential improvements of the prognosis after distal curative gastrectomy for gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antiperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group | Experimental | Procedure: Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstructionThe isoperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was consistent. |
| Isoperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group | Active comparator | Procedure: Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstructionThe antiperistaltic anastomosis represents the peristalsis direction of remnant stomach and jejunal efferent loop was opposite. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 1) Pathological examination confirmation the adenocarcinoma of stomach before surgery
- 2) Physical conditions compliance with the requirements for curative gastrectomy
- 3) Consent to undergo the D2 lymphadenectomy, and the dissected proportion of stomach no less than 2/3
- 4) Comply with the protocol during the whole study period
- 5) No neoadjuvant therapy administration
Key exclusion criteria (10 listed)
- 1) Women during pregnant stage and breast-feed stage
- 2) Women of childbearing age without any contraceptive measures
- 3) Severe congestive heart failure, frequent arrhythmia, or myocardial infarction within 12 months
- 4) Immunosuppressive therapists for organ transplantation
- 5) Seriously uncontrolled recurrent infection
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 |
|---|---|---|
| Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstructionIn this study, intervention methods include two kind directions of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer. One is the isoperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was consistent. The other is the antiperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was opposite. | Procedure or surgery | Antiperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group, Isoperistaltic direction of gastrointestinal anastomosis in Roux-en-Y reconstruction group |
Primary outcome
Early postoperative recovery results
Time frame: Within 1 month after surgery
Differences of effects of early recovery postoperatively (exhaust, defecation, eating, residual stomach peristalsis, length of hospital stay, etc.)
Late postoperative recovery results
Time frame: 1 year after surgery
Differences of late gastrointestinal effects (bile reflux, residual gastritis, gastric emptying function, etc.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction in people with Peristaltic Direction and Roux-en-Y Gastrointestinal Anastomosis, run by Tianjin Medical University Cancer Institute and 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 14 inclusion and 10 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 22 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingyu Deng, M.D. (+86-22-23340123, dengery@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early postoperative recovery results (time frame: Within 1 month after surgery). The study lists 2 primary outcomes in all. 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 22 Mar 2022.