Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02837874
• Other study ID #: 2016-02-052
• Status: Recruiting
• Phase: N/A
• First received: July 8, 2016
• Last updated: November 12, 2017
• Start date: March 2016
• Est. completion date: March 2019

Study information

• Verified date: November 2017
• Source: Keimyung University Dongsan Medical Center
• Contact: Seung Wan Ryu, M.D., Ph.D.
• Phone: 82-53-250-7322
• Email: gsman[@]dsmc.or.kr
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• Isoperistaltic
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

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Keimyung University Dongsan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Bergamaschi R, Arnaud JP, Mårvik 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dumping syndrome	Using Sigstad's score	12 months
Secondary	long-term complication	all kind of complication	from 1 month to 12 months
Secondary	Total score of quality of life questionnaire	by EORTC questionnaire	12 months
Secondary	Body weight change	for evaluate nutritional status	12 months
Secondary	Surgical complication	all kind of complication within 1 month	within 1 month
Secondary	Gastritis	by endoscopic evaluation	12 months