NCT02837874

Brief 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. The investigators will assess complications, dumping syndrome and quality of life between isoperistaltic and antiperistaltic after distal gastrectomy for gastric cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

3 years

First QC Date

July 8, 2016

Last Update Submit

November 12, 2017

Conditions

Stomach Neoplasms

Keywords

Gastric cancergastrojejunostomyisoperistalticantiperistaltic

Outcome Measures

Primary Outcomes (1)

  • Dumping syndrome

    Using Sigstad's score

    12 months

Secondary Outcomes (5)

  • long-term complication

    from 1 month to 12 months

  • Total score of quality of life questionnaire

    12 months

  • Body weight change

    12 months

  • Surgical complication

    within 1 month

  • Gastritis

    12 months

Study Arms (2)

Isoperistaltic

ACTIVE COMPARATOR

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

Procedure: Isoperistaltic

Antiperistaltic

EXPERIMENTAL

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

Procedure: Antiperistaltic

Interventions

IsoperistalticPROCEDURE

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

Isoperistaltic
AntiperistalticPROCEDURE

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

Antiperistaltic

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

RECRUITING

Related Publications (4)

  • 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.

    PMID: 23233009RESULT

  • 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.

    PMID: 12496544RESULT

  • 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.

    PMID: 20829078RESULT

  • 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.

    PMID: 8763175RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Antidiarrheals

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Seung Wan Ryu, M.D., Ph.D.

    Keimyung University Dongsan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

82-53-250-7322gsman@dsmc.or.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastrointesinal surgery, professor

Study Record Dates

First Submitted

July 8, 2016

First Posted

July 20, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

Locations

KR(1)