NCT00622804

Brief Summary

The purpose of this study is to evaluate the degree of bile reflux and gastric stasis according the reconstruction methods after distal subtotal gastrectomy for gastric cancer, and to find out the proper method. We collect ninety patients who undergo distal gastrectomy for gastric cancers for this study from 5 institutions and randomly divide into 3 groups according to reconstruction methods: 1) Billroth-II (B-II), 2) Roux en Y gastrojejunostomy (RY-GJ) and 3) uncut Roux en Y gastrojejunostomy (uncut RY-GJ).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 25, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Last Updated

August 3, 2009

Status Verified

July 1, 2009

Enrollment Period

2 years

First QC Date

February 14, 2008

Last Update Submit

July 31, 2009

Conditions

Stomach CancerGastrectomy

Keywords

Stomach cancerGastrectomyPostgastrectomy syndrome

Outcome Measures

Primary Outcomes (1)

  • Bile reflux by Dual scintigraphy

    six month and one year after operation

Secondary Outcomes (4)

  • Gastric emptying time by Dual scintigraphy

    six month and one year after operation

  • Residual food, gastritis, bile reflux and reflux esophagitis by Gastrofiberscope findings

    six month and one year after operation

  • Quality of life by EORTC QLQ30, STO22

    one year after operation

  • Morbidity and Mortality

    In hosipital

Study Arms (3)

1

OTHER

Billroth-II (B-II)reconstruction

Procedure: Billroth-II (B-II)

2

OTHER

Roux en Y gastrojejunostomy (RY-GJ)

Procedure: Roux en Y gastrojejunostomy (RY-GJ)

3

OTHER

uncut Roux en Y gastrojejunostomy (uncut RY-GJ)

Procedure: uncut Roux en Y gastrojejunostomy

Interventions

Billroth-II (B-II)PROCEDURE

After conventional distal gastrectomy with lymphadenectomy, jejunum of a distal segment from 10 to 20cm from Treitz is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done.

Also known as: B-II
1
Roux en Y gastrojejunostomy (RY-GJ)PROCEDURE

After conventional distal gastrectomy with lymphadenectomy, jejunum is transected in the segment from 10 to 20 cm, and then distal end is transposed in a way of retro-colon to perform anastomosis using 60mm linear cutting stapler or hand-sawing technique with absorbable suture. After anastomosis, reinforcement suture is done. The resected proximal jejunum and the portion of jejunum distal 45 cm from gastrojejunostomy are anastomosed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture.

Also known as: RY-GJ
2
uncut Roux en Y gastrojejunostomyPROCEDURE

After conventional distal gastrectomy with lymphadenectomy, jejunum of distal segment 45 cm from Treitz ligament is used for reconstruction. Jejunal segment is transposed in a way of ante-colon, and then gastrojejunostomy is performed using 60mm linear cutting stapler or hand-sawing technique with absorbable suture followed by reinforcement suture. After anastomosis, afferent loop distal 5cm is obstructed using non-cutting stapler or hand sawing suture. And then, distal jejunum 10 cm from obstructive portion and efferent jejunal loop distal 45 cm from gastrojejunostomy are anastomosed in a manner of side to side followed by reinforcement suture.

Also known as: uncut RY-GJ
3

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent distal gastrectomy for adenocarcinoma of stomach with following criteria:
  • have cancer located in middle or distal portions
  • preoperative staged as cT1N0M0 or cT2N0M0 by computed tomography and gastrofiberscope (Endoscopic ultrasound, optionally)
  • have The American Society of Anaesthesiologists (ASA) score of three and less

You may not qualify if:

  • Patients following criteria:
  • have simultaneously other cancer
  • underwent cancer therapy (radiologic or immunologic or chemotherapeutic method) at past time
  • have systemic inflammatory disease
  • have upper gastrointestinal surgery
  • have the gastric cancer with obstruction
  • get pregnancy
  • are treating diabetics with Insulin
  • are participating or participated within 1 month in other clinical trials
  • have BMI less than 25
  • are expected to perform laparoscopy assisted gastrectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Surgery, Holy Family Hospital, The Catholic University of Korea

Bucheon-si, 420-717, South Korea

Location

Department of Surgery, Our Lady of Mercy Hospital, The Catholic University of Korea

Incheon, 403-720, South Korea

Location

Department of Surgery, Kangnam St. Mary's Hospital, The Catholic University of Korea

Seoul, 137-710, South Korea

Location

Department of Surgery, St Mary's Hospital, The Catholic University of Korea

Seoul, 150-713, South Korea

Location

Department of Surgery, St. Vincent's Hopital, The Catholic University of Korea

Suwon, 442-723, South Korea

Location

Related Publications (1)

  • Ogoshi K, Okamoto Y, Nabeshima K, Morita M, Nakamura K, Iwata K, Soeda J, Kondoh Y, Makuuchi H. Focus on the conditions of resection and reconstruction in gastric cancer. What extent of resection and what kind of reconstruction provide the best outcomes for gastric cancer patients? Digestion. 2005;71(4):213-24. doi: 10.1159/000087046. Epub 2004 Sep 6.

    PMID: 16024924BACKGROUND

MeSH Terms

Conditions

Stomach NeoplasmsPostgastrectomy Syndromes

Interventions

GastroenterostomyGastric Bypass

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical ProceduresBariatric SurgeryBariatricsObesity ManagementTherapeutics

Study Officials

  • Wook Kim, MD, PhD

    Department of Surgery, Holy Family Hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2008

First Posted

February 25, 2008

Study Start

July 1, 2007

Primary Completion

July 1, 2009

Last Updated

August 3, 2009

Record last verified: 2009-07

Locations

KR(5)