AzTrials
AzTrials

Stomach NeoplasmsNCT02837874

Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

A study testing Isoperistaltic and Antiperistaltic in people with Stomach Neoplasms, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

Billroth-II (gastrojejunostomy) is one of major option after gastrectomy for gastric cancer. The investigators hypothesized that isoperistaltic anastomosis lead to higher incidence of dumping syndrome but antiperistaltic (anisoperistaltic) anastomosis have relevance to gastric stasis or obstruction. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Stomach Neoplasms
What is being tested?
Isoperistaltic and Antiperistaltic
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSouth Korea
Study dates
Mar 2016to Mar 2019
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma in stomach
  • Scheduled as laparoscopic distal gastrectomy (tumor located lower or middle third)
  • Planned with gastrojejunostomy after gastrectomy
  • Clinical stage T1N0M0 or T2N0M0
  • ECOG 0 or 1 (The Eastern Cooperative Oncology Group)
  • ASA score class I-III (The American Society of Anesthesiologists)
  • patient has given their written informed consent to participate in the study

Who cannot join

  • Simultaneously combined resection of other organ (including cholecystectomy)
  • Active other malignancy
  • Requiring total gastrectomy
  • Chronic inflammatory bowel disease or other chronic disease related to bowel motility
  • Uncontrolled diabetes or patients with diabetic complications
  • Vulnerable patients

Trial locations and contacts

1 site in 1 country.

Seung Wan Ryu, M.D., Ph.D. contact

82-53-250-7322

gsman@dsmc.or.kr

South Korea1 site, 1 recruiting

  • Keimyung University Dongsan Medical Center

    Daegu, 700-712

    Seung Wan Ryu, MD, PhD, 82-53-250-7322, gsman@dsmc.or.kr

    In Gyu Kwon, MD, 82-53-250-7322, surgeon@dsmc.or.kr

    Recruiting

Other trials in South Korea

About this study

Official title: Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy, Randomized Prospective Pilot Study

Billroth-II (gastrojejunostomy) is one of major option after gastrectomy for gastric cancer. The investigators hypothesized that isoperistaltic anastomosis lead to higher incidence of dumping syndrome but antiperistaltic (anisoperistaltic) anastomosis have relevance to gastric stasis or obstruction. The investigators will assess complications, dumping syndrome and quality of life between isoperistaltic and antiperistaltic after distal gastrectomy for gastric cancer.

Read the detailed description

Recently, laparoscopic approach has been a option for gastric cancer, especially early gastric cancer. There are growing interest in quality of life in addition to recurrence or survival. There are few report about peristalsis and no report for quality of life according to a direction of peristalsis.

Being tested
Isoperistaltic, Antiperistaltic
Keywords
Gastric cancer, gastrojejunostomy, isoperistaltic, antiperistaltic
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • IsoperistalticProcedure or surgery

    Same direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the distal part of remnant stomach

  • AntiperistalticProcedure or surgery

    Reverse direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the proximal part of remnant stomach

Study groups in NCT02837874
Study groupRoleWhat they receive
IsoperistalticActive comparatorSame direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the distal part of remnant stomach
Receives: Procedure: Isoperistaltic
AntiperistalticExperimentalReverse direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the proximal part of remnant stomach
Receives: Procedure: Antiperistaltic

What is being measured

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

  1. Dumping syndrome

    Using Sigstad's score

    Measured: 12 months

Secondary outcomes (5)

  1. long-term complication

    all kind of complication

    Measured: from 1 month to 12 months

  2. Total score of quality of life questionnaire

    by EORTC questionnaire

    Measured: 12 months

  3. Body weight change

    for evaluate nutritional status

    Measured: 12 months

  4. Surgical complication

    all kind of complication within 1 month

    Measured: within 1 month

  5. Gastritis

    by endoscopic evaluation

    Measured: 12 months

Timeline

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

  1. First posted20 Jul 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionMar 2019 (estimated)
  4. Study completionMar 2019 (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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02837874
Sponsor's protocol ID
2016-02-052
Status last verified
Nov 2017
First submitted
8 Jul 2016
Last updated
14 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Banerjee A, Ding Y, Mikami DJ, Needleman BJ. The role of dumping syndrome in weight loss after gastric bypass surgery. Surg Endosc. 2013 May;27(5):1573-8. doi: 10.1007/s00464-012-2629-1. Epub 2012 Dec 12.

    PubMed 23233009

  • Bergamaschi R, Arnaud JP, Marvik R, Myrvold HE. Laparoscopic antiperistaltic versus isoperistaltic gastrojejunostomy for palliation of gastric outlet obstruction in advanced cancer. Surg Laparosc Endosc Percutan Tech. 2002 Dec;12(6):393-7. doi: 10.1097/00129689-200212000-00002.

    PubMed 12496544

  • Mine S, Sano T, Tsutsumi K, Murakami Y, Ehara K, Saka M, Hara K, Fukagawa T, Udagawa H, Katai H. Large-scale investigation into dumping syndrome after gastrectomy for gastric cancer. J Am Coll Surg. 2010 Nov;211(5):628-36. doi: 10.1016/j.jamcollsurg.2010.07.003. Epub 2010 Sep 15.

    PubMed 20829078

  • Houghton AD, Liepins P, Clarke S, Mason R. Iso- or antiperistaltic anastomosis: does it matter? J R Coll Surg Edinb. 1996 Jun;41(3):148-51.

    PubMed 8763175

Questions about this trial

What is this clinical trial studying?

A study testing Isoperistaltic and Antiperistaltic in people with Stomach Neoplasms, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.

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 6 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 14 Nov 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 South Korea. 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 Seung Wan Ryu, M.D., Ph.D. (82-53-250-7322, gsman@dsmc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dumping syndrome (time frame: 12 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 NCT02837874, which also lists 4 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 14 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in