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Nutrition DisordersPhase 3NCT02763878

Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy

A Phase 3 study testing Uncut Roux-en-Y anastomosis and Billroth II anastomosis in people with Nutrition Disorders and Postoperative Complications, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators intend to conduct multi-center randomized controlled study to find if Uncut Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the long-term complications, affect the quality of life, and improve the prognosis, comparing to Billroth II anastomosis. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Uncut Roux-en-Y anastomosis and Billroth II anastomosis
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
832 participants
Where
1 siteChina
Study dates
Sep 2016to Dec 2020
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • pathological diagnosed as the gastric carcinoma, the possibility of removal by the surgeon and imaging physician assessment.
  • no previous history of other malignancies combined.
  • patients have signed informed consent;
  • aged 18 to 80 years old, male or female patients;
  • cardiopulmonary, liver and kidney function was normal, ECOG physical status score of 0 to 1 (see Appendix);
  • the clinician determine the patient does not need emergency surgery;

Who cannot join

  • pregnant or lactating women;
  • the liver, lung, bone, and other distant metastasis;
  • supraclavicular lymph nodes, pelvic or ovarian species, peritoneal dissemination, etc;
  • a large number of ascites, cachexia;
  • suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, poorly controlled hypertension merger, diabetes patients;
  • or mental illness;
Show all 12Show fewer
  • 4 weeks prior to enrollment participated or are participating in other clinical trials of patients;
  • had undergone surgery, and its influence has not been eliminated in the patient;
  • of the stomach or esophagus history of malignancy, including stromal tumor, sarcoma, lymphoma, carcinoid;
  • patients with active infection (infection causing fever above 38 ℃);
  • patients with poor compliance or researchers consider poor patient compliance;
  • There are other clinical researchers believe that the laboratory the patient should not participate in the trial.

Trial locations and contacts

1 site in 1 country.

Jun-Sheng Peng, PH.D contact

+862038254020

chensh47@mail.sysu.edu.cn

Shi Chen, PH.D contact

+862038254092

cscp@163.com

China1 site, 1 recruiting

  • The sixth affliated hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Jun-Sheng Peng, Ph.D, +862038254020, chensh47@mail.sysu.edu.cn

    Shi Chen, Ph.D, +862038254092, cscp@163.com

    Recruiting

Other trials in China

About this study

The investigators intend to conduct multi-center randomized controlled study to find if Uncut Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the long-term complications, affect the quality of life, and improve the prognosis, comparing to Billroth II anastomosis.

Read the detailed description

Gastric cancer is still one of the most common malignant tumors, and gastric antrum cancer is still common. Radical surgery is the only way to treat gastric antrum cancer, surgical procedures and reconstruction are closely related with the prognosis and quality of life, the choice is crucial. Gastrojejunostomy after distal gastrectomy may affect the quality of radical surgery, and postoperative diet, nutritional status and quality of life. More and more centers tend to choose Billroth II anastomosis, but patients prone to have a variety of complications, including reflux gastritis and bile reflux, malnutrition, seriously affecting the quality of life and so on. According to preliminary pilot study found that, uncut Roux-en-Y anastomosis way can keep the continuity of nerve-muscle function of the reconstruction of digestive tract, and closes the input in order to reduce the incidence of reflux, for improving the nutritional status and reducing complications and improve quality of life. Therefore, the investigators intend to conduct multi-center randomized controlled study to find if Uncut Roux-en-Y anastomosis to the distal gastric cancer patients after radical D2 can reduce the long-term complications, affect the quality of life, and improve the prognosis.

Being tested
Uncut Roux-en-Y anastomosis, Billroth II anastomosis
Keywords
Uncut Roux-en-Y, Billroth II anastomosis, Distal gastric cancer, Nutrition status, Postoperative complications
Medical subject headings
Nutrition Disorders, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Uncut Roux-en-Y anastomosisProcedure or surgery

    Uncut Closure devices would be used to close the intestinal cavity on the input less than 5cm distance from the loop gastrojejunostomy anastomosis.

  • Billroth II anastomosisProcedure or surgery

    Typical Billroth II anastomosis would be made after the Distal gastrectomy.

Study groups in NCT02763878
Study groupRoleWhat they receive
uncut Roux-en-Y anastomosisExperimentalAfter distal gastrectomy, duodenal stump closure, side to side anastomosis was underwent on the remnant stomach and jejunum,which was 25cm from Treitz ligament. Then underwent side to side anastomosis between jejunum about 35cm distance from gastrojejunostomy and jejunum about 5cm from Triez ligament . close the intestinal cavity on the input less than 5cm distance from the loop gastrojejunostomy anastomosis by using uncut Closure devices
Receives: Procedure: Uncut Roux-en-Y anastomosis
Billroth II anastomosisSham comparatorAfter distal gastrectomy, duodenal stump closure, the investigators first underwent remnant stomach and upper jejunum side anastomosis. Then choose the jejunum about 25cm from Treitz ligament, premenstrual colon using a disposable cutting closure (or tubular stapling) in the rear wall of the stomach and jejunum anastomosis, common opening was closed with the (barbed wire) hand-stitched. After that, steps were same with the group A.
Receives: Procedure: Billroth II anastomosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related gastrointestinal and gastroesophageal reflux as assessed by The Los Angeles and Savary-Miller systems for grading esophagitis

    Measured: 0-5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
832 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02763878
Sponsor's protocol ID
CSGC-002
Status last verified
May 2017
First submitted
5 Feb 2016
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: The investigators would like to share the data to the Participating units.

Publications

  • Yun SC, Choi HJ, Park JY, Kim YJ. Total laparoscopic uncut Roux-en-Y gastrojejunostomy after distal gastrectomy. Am Surg. 2014 Feb;80(2):E51-3. No abstract available.

    PubMed 24480200

  • Ahn SH, Son SY, Lee CM, Jung DH, Park do J, Kim HH. Intracorporeal uncut Roux-en-Y gastrojejunostomy reconstruction in pure single-incision laparoscopic distal gastrectomy for early gastric cancer: unaided stapling closure. J Am Coll Surg. 2014 Jan;218(1):e17-21. doi: 10.1016/j.jamcollsurg.2013.09.009. Epub 2013 Nov 23. No abstract available.

    PubMed 24280449

  • Mon RA, Cullen JJ. Standard Roux-en-Y gastrojejunostomy vs. "uncut" Roux-en-Y gastrojejunostomy: a matched cohort study. J Gastrointest Surg. 2000 May-Jun;4(3):298-303. doi: 10.1016/s1091-255x(00)80079-7.

    PubMed 10769093

  • 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 38421211

  • Chen S, Chen DW, Chen XJ, Lin YJ, Xiang J, Peng JS. Postoperative complications and nutritional status between uncut Roux-en-Y anastomosis and Billroth II anastomosis after D2 distal gastrectomy: a study protocol for a multicenter randomized controlled trial. Trials. 2019 Jul 12;20(1):428. doi: 10.1186/s13063-019-3531-0.

    PubMed 31300019

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Uncut Roux-en-Y anastomosis and Billroth II anastomosis in people with Nutrition Disorders and Postoperative Complications, run by Sixth Affiliated Hospital, Sun Yat-sen 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 6 inclusion and 12 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 21 Jul 2017. 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. Some participants in this study may receive a placebo. 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 Jun-Sheng Peng, PH.D (+862038254020, chensh47@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related gastrointestinal and gastroesophageal reflux as assessed by The Los Angeles and Savary-Miller systems for grading esophagitis (time frame: 0-5 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 NCT02763878, which also lists 5 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 21 Jul 2017.

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