Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

Keimyung University

Status: Unknown

Conditions: Stomach Neoplasms

Treatments: Procedure: Antiperistaltic; Procedure: Isoperistaltic

Study type: Interventional

Funder types: Other

Identifiers

NCT02837874

2016-02-052

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Isoperistaltic

Active Comparator group

Description:

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

Treatment:

Procedure: Isoperistaltic

Antiperistaltic

Experimental group

Description:

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

Treatment:

Procedure: Antiperistaltic