Clinical trial NCT01142271: Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy
Official title: Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy for Gastric Cancer Patients : Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastrectomy
Keywords: Distal gastrectomy
Reconstruction
Reflux
subtotal gastrectomy
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2010-06-11
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to compare the degree of reflux, operative outcomes and quality of life between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer

Detailed description: Most common procedure for the resection of gastric cancers located in middle or lower stomach is distal subtotal gastrectomy. However, the optimal reconstruction procedure after that has still not to be established. Although B-I reconstruction is most common method due to the safety and simplicity, the duodenal fluid may reflux into the remnant stomach which may contribute to the mucosal injury to remnant stomach and esophagus. Roux en Y reconstruction may reduce the reflux to remnant stomach due to the length of Roux en Y limb, although it is more complicated procedure.

Therefore, we plan to collect 120 patients to compare the degree of reflux between Roux en Y and Billroth-I reconstructions after distal subtotal gastrectomy for gastric cancer. In addition, we compare the surgical outcome and quality of life between two groups.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with adenocarcinoma at the endoscopic biopsy
* Patients who are possible to be performed curative resection in imaging study
* Patients with tumor which not involved in pylorus and are located in mid or distal portion of the stomach
* Patients with informed consent
* Patients with three or less American Society Anesthesiology Score 3

Exclusion Criteria:

* Patients who are or become pregnant
* Patients with uncontrolled disease
* Patient s with synchronous other malignancy
* Patients participated in other clinical trial

Primary outcomes:
measure: Reflux of bile content
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Quality of Life
timeFrame: 6 months after surgery
measure: Morbidity
timeFrame: 2 month after surgery
measure: Anastomotic time
timeFrame: Day 1
measure: Nutritional state
timeFrame: 6 month after surgery
measure: Mortality
timeFrame: 2 month after operation
measure: Operation time
timeFrame: Day 1
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Department of Surgery, Ajou University School of Medicine
name: Sang-Uk Han, M.D., Ph D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Surgery, Ajou University School of Medicine
name: Hoon Hur, M.D.
role: STUDY_DIRECTOR
References:
citation: Chan DC, Fan YM, Lin CK, Chen CJ, Chen CY, Chao YC. Roux-en-Y reconstruction after distal gastrectomy to reduce enterogastric reflux and Helicobacter pylori infection. J Gastrointest Surg. 2007 Dec;11(12):1732-40. doi: 10.1007/s11605-007-0302-0. Epub 2007 Sep 18.
citation: Ishikawa M, Kitayama J, Kaizaki S, Nakayama H, Ishigami H, Fujii S, Suzuki H, Inoue T, Sako A, Asakage M, Yamashita H, Hatono K, Nagawa H. Prospective randomized trial comparing Billroth I and Roux-en-Y procedures after distal gastrectomy for gastric carcinoma. World J Surg. 2005 Nov;29(11):1415-20; discussion 1421. doi: 10.1007/s00268-005-7830-0.
citation: Nishizaki D, Ganeko R, Hoshino N, Hida K, Obama K, Furukawa TA, Sakai Y, Watanabe N. Roux-en-Y versus Billroth-I reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2021 Sep 15;9(9):CD012998. doi: 10.1002/14651858.CD012998.pub2.
citation: Hur H, Ahn CW, Byun CS, Shin HJ, Kim YB, Son SY, Han SU. A Novel Roux-en-Y Reconstruction Involving the Use of Two Circular Staplers after Distal Subtotal Gastrectomy for Gastric Cancer. J Gastric Cancer. 2017 Sep;17(3):255-266. doi: 10.5230/jgc.2017.17.e32. Epub 2017 Sep 26.