Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

NCT ID: NCT02837874

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stomach Neoplasms

Keywords

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Gastric cancer gastrojejunostomy isoperistaltic antiperistaltic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Isoperistaltic

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

Group Type ACTIVE_COMPARATOR

Isoperistaltic

Intervention Type PROCEDURE

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

Antiperistaltic

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

Group Type EXPERIMENTAL

Antiperistaltic

Intervention Type PROCEDURE

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

Interventions

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Isoperistaltic

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

Intervention Type PROCEDURE

Antiperistaltic

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Seung Wan Ryu

Director of Gastrointesinal surgery, professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Keimyung University Dongsan Medical Center

Locations

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Keimyung University Dongsan Medical Center

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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

Role: CONTACT

Phone: 82-53-250-7322

Email: [email protected]

Facility Contacts

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Seung Wan Ryu, MD, PhD

Role: primary

In Gyu Kwon, MD

Role: backup

References

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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.

Reference Type RESULT
PMID: 23233009 (View on PubMed)

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.

Reference Type RESULT
PMID: 12496544 (View on PubMed)

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.

Reference Type RESULT
PMID: 20829078 (View on PubMed)

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.

Reference Type RESULT
PMID: 8763175 (View on PubMed)

Other Identifiers

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2016-02-052

Identifier Type: -

Identifier Source: org_study_id