Gastric CancerPhase 2NCT02644148
Uncut Roux-en-Y Gastrojejunostomy for Early Gastric Cancer Patients
A Phase 2 study testing Conventional Roux-en-Y Gastrojejunostomy and Uncut Roux-en-Y Gastrojejunostomy in people with Gastric Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The current commonly used for distal gastri cancer in gastrointestinal anastomosis is Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the result of interruption of intestine peristalsis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Conventional Roux-en-Y Gastrojejunostomy and Uncut Roux-en-Y Gastrojejunostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Feb 2019
- Phase
- Phase 2
- 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
- Endoscopy and biopsy confirmed gastric antrum or angle (from the cardia more than 4cm) of gastric cancer
- tumor stage: I
- There is no experience with chemotherapy, no distant metastasis
- Have their own ability to answer the questionnaire
- There is no mental illness
- Age between 18-70 years old
- Agreed to participate in the experiment and signed informed consent
Who cannot join
- pregnant or nursing patients
- The combined more serious cardiovascular disease, liver and kidney dysfunction (glutamic-pyruvic transaminase/glutamic oxalacetic transaminase more than three times the upper limit of normal, serum creatinine more than 50% higher than the upper limit of normal), abnormal blood clotting function (mean prothrombin time, activated partial thromboplastin time higher than normal values above the upper limit of 50%), neuropsychiatric disorders
- Patients with active infection
- Have other malignant tumor
- Some reason withdraw subjects, can not enrolled in the study again
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Hao Xu, Doc., 0086 13851530117, 66881866@qq.com
About this study
Official title: The Effect of Uncut Roux-en-Y Gastrojejunostomy on Quality of Life After Laparoscopic Distal Gastrectomy for Early Gastric Cancer Patients
The current commonly used for distal gastri cancer in gastrointestinal anastomosis is Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the result of interruption of intestine peristalsis. In 2013, Kim reported total laparoscopic uncut Roux-en-Y anastomosis could reduce Roux stasis syndrome incidence by keeping the continuity of jejunum. In September 2014, we carried out this operation in 30 cases in our centre. Our previous results showed that this operation had a low postoperative complication and short hospitalization time, indicating uncut Roux-en-Y anastomosis might be a safe procedure. However, some limitations are noticed. The report from South Korea is a retrospective study and the evaluation of QOL is certain subjective. Here, we aimed to perform the first randomized controlled clinical study on uncut Roux-en-Y anastomosis to improve QOL of patients after laparoscopic distal gastrectomy.
Read the detailed description
The current commonly used for distal gastri cancer in gastrointestinal anastomosis is Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the result of interruption of intestine peristalsis. In 2013, Kim reported total laparoscopic uncut Roux-en-Y anastomosis could reduce Roux stasis syndrome incidence by keeping the continuity of jejunum. In September 2014, we carried out this operation in 30 cases in our centre. Our previous results showed that this operation had a low postoperative complication and short hospitalization time, indicating uncut Roux-en-Y anastomosis might be a safe procedure. However, some limitations are noticed. The report from South Korea is a retrospective study and the evaluation of QOL is certain subjective. Here, we aimed to perform the first randomized controlled clinical study on uncut Roux-en-Y anastomosis to improve QOL of patients after laparoscopic distal gastrectomy. The primary aim is to determine whether uncut Roux-en-Y anastomosis improve the quality of life of patients after laparoscopic distal gastrectomy.
- Conditions
- Gastric Cancer
- Being tested
- Conventional Roux-en-Y Gastrojejunostomy, Uncut Roux-en-Y Gastrojejunostomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Roux-en-Y GastrojejunostomyProcedure or surgery
Conventional Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients
Uncut Roux-en-Y GastrojejunostomyProcedure or surgery
Uncut Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Conventional Roux-en-Y anastomosis | Other | Conventional Roux-en-Y Gastrojejunostomy will be used after laparoscopic distal gastrectomy for early gastric cancer. Receives: Procedure: Conventional Roux-en-Y Gastrojejunostomy |
| Uncut Roux-en-Y anastomosis | Experimental | Uncut Roux-en-Y Gastrojejunostomy will be used after laparoscopic distal gastrectomy for early gastric cancer. Receives: Procedure: Uncut Roux-en-Y Gastrojejunostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: one year
Secondary outcomes (1)
Complications
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekuan Xu, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Zekuan Xu, Professor, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02644148
- Sponsor's protocol ID
- JSPH-0504
- Status last verified
- Aug 2016
- First submitted
- 30 Dec 2015
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be open access.
Publications
Cai Z, Mu M, Ma Q, Liu C, Jiang Z, Liu B, Ji G, Zhang B. Uncut Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2024 Feb 29;2(2):CD015014. doi: 10.1002/14651858.CD015014.pub2.
PubMed 38421211Xu H, Yang L, Zhang DC, Li Z, Li QY, Wang LJ, Li FY, Wang WZ, Xia YW, Xu ZK. To cut or not to cut? A prospective randomized controlled trial on short-term outcomes of the uncut Roux-en-Y reconstruction for gastric cancer. Surg Endosc. 2023 Aug;37(8):6172-6184. doi: 10.1007/s00464-023-10067-0. Epub 2023 May 9.
PubMed 37160808
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Uncut Roux-en-Y Gastrojejunostomy on Quality of Life After Laparoscopic Distal Gastrectomy for Early Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT02644148
- Acronym / sponsor ID
- JSPH-0504
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 31 Dec 2015 (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 current commonly used for distal gastri cancer in gastrointestinal anastomosis is Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the result of interruption of intestine peristalsis. In 2013, Kim reported total laparoscopic uncut Roux-en-Y anastomosis could reduce Roux stasis syndrome incidence by keeping the continuity of jejunum. In September 2014, we carried out this operation in 30 cases in our centre. Our previous results showed that this operation had a low postoperative complication and short hospitalization time, indicating uncut Roux-en-Y anastomosis might be a safe procedure. However, some limitations are noticed. The report from South Korea is a retrospective study and the evaluation of QOL is certain subjective. Here, we aimed to perform the first randomized controlled clinical study on uncut Roux-en-Y anastomosis to improve QOL of patients after laparoscopic distal gastrectomy.
Detailed description
The current commonly used for distal gastri cancer in gastrointestinal anastomosis is Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the result of interruption of intestine peristalsis. In 2013, Kim reported total laparoscopic uncut Roux-en-Y anastomosis could reduce Roux stasis syndrome incidence by keeping the continuity of jejunum. In September 2014, we carried out this operation in 30 cases in our centre. Our previous results showed that this operation had a low postoperative complication and short hospitalization time, indicating uncut Roux-en-Y anastomosis might be a safe procedure. However, some limitations are noticed. The report from South Korea is a retrospective study and the evaluation of QOL is certain subjective. Here, we aimed to perform the first randomized controlled clinical study on uncut Roux-en-Y anastomosis to improve QOL of patients after laparoscopic distal gastrectomy. The primary aim is to determine whether uncut Roux-en-Y anastomosis improve the quality of life of patients after laparoscopic distal gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Roux-en-Y anastomosis | Other | Procedure: Conventional Roux-en-Y GastrojejunostomyConventional Roux-en-Y Gastrojejunostomy will be used after laparoscopic distal gastrectomy for early gastric cancer. |
| Uncut Roux-en-Y anastomosis | Experimental | Procedure: Uncut Roux-en-Y GastrojejunostomyUncut Roux-en-Y Gastrojejunostomy will be used after laparoscopic distal gastrectomy for early gastric cancer. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Endoscopy and biopsy confirmed gastric antrum or angle (from the cardia more than 4cm) of gastric cancer
- tumor stage: I
- There is no experience with chemotherapy, no distant metastasis
- Have their own ability to answer the questionnaire
- There is no mental illness
Key exclusion criteria (5 listed)
- pregnant or nursing patients
- The combined more serious cardiovascular disease, liver and kidney dysfunction (glutamic-pyruvic transaminase/glutamic oxalacetic transaminase more than three times the upper limit of normal, serum creatinine more than 50% higher than the upper limit of normal), abnormal blood clotting function (mean prothrombin time, activated partial thromboplastin time higher than normal values above the upper limit of 50%), neuropsychiatric disorders
- Patients with active infection
- Have other malignant tumor
- Some reason withdraw subjects, can not enrolled in the study again
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 |
|---|---|---|
| Conventional Roux-en-Y GastrojejunostomyConventional Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients | Procedure or surgery | Conventional Roux-en-Y anastomosis |
| Uncut Roux-en-Y GastrojejunostomyUncut Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients | Procedure or surgery | Uncut Roux-en-Y anastomosis |
Primary outcome
Quality of life
Time frame: one year
1 secondary outcome
Complications
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Derived from this study: PubMed 38421211Cai Z, Mu M, Ma Q, Liu C, Jiang Z, Liu B, Ji G, Zhang B. Uncut Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2024 Feb 29;2(2):CD015014. doi: 10.1002/14651858.CD015014.pub2.
- Derived from this study: PubMed 37160808Xu H, Yang L, Zhang DC, Li Z, Li QY, Wang LJ, Li FY, Wang WZ, Xia YW, Xu ZK. To cut or not to cut? A prospective randomized controlled trial on short-term outcomes of the uncut Roux-en-Y reconstruction for gastric cancer. Surg Endosc. 2023 Aug;37(8):6172-6184. doi: 10.1007/s00464-023-10067-0. Epub 2023 May 9.
- Individual participant dataSharing planned: Yes. Data will be open access.
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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.
Zekuan Xu, Professor principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conventional Roux-en-Y Gastrojejunostomy and Uncut Roux-en-Y Gastrojejunostomy in people with Gastric Cancer, run by The First Affiliated Hospital with Nanjing Medical University 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 7 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: status not confirmed, as of the sponsor's last update on 11 Aug 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Hao Xu, Doctor (0086 13851530117, hxu@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: one year). 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 NCT02644148, which also lists 2 linked publications.
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 11 Aug 2016.