Clinical trial NCT02837874: Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy
Official title: Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy, Randomized Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stomach Neoplasms
Keywords: Gastric cancer
gastrojejunostomy
isoperistaltic
antiperistaltic
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2016-07-20
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dumping syndrome
timeFrame: 12 months
Secondary outcomes:
measure: long-term complication
timeFrame: from 1 month to 12 months
measure: Total score of quality of life questionnaire
timeFrame: 12 months
measure: Body weight change
timeFrame: 12 months
measure: Surgical complication
timeFrame: within 1 month
measure: Gastritis
timeFrame: 12 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
Study officials:
affiliation: Keimyung University Dongsan Medical Center
name: Seung Wan Ryu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.2010.07.003. Epub 2010 Sep 15.
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.