Comparison Study for Bile Reflux and Gastric Stasis in Patients After Distal Gastrectomy

July 31, 2009 updated by: The Catholic University of Korea

Phase III Study on Comparison for Bile Reflux and Gastric Stasis in Patients With Gastric Cancer After Distal Gastrectomy

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).

Study Overview

Detailed Description

Patients who have undergone gastrectomy for gastric cancer might be developed various symptoms by gastric stasis and bile reflux, it so called "post-gastrectomy syndrome", because of the diminishment of stomach capacity, the decrease of expulsive ability and the change of food passage. Until now, that had been accepted as the inevitable results after gastric resection. However, the survival rate has recently been increased owing to the increased proportion of early gastric cancer. And thus, to improve the quality of life of patients, many researchers have been actually studying for the reconstruction methods which are able to minimize the symptom by gastrectomy, but it is dissatisfied until now. Thus, 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). We evaluate the postoperative morbidity rate and then the degree of bile reflux, gastric emptying time and quality of life through long term follow-up using the gastrofiberscope, survey and so on.

From this study, we would suggest the standard reconstruction procedure after distal gastrectomy.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bucheon, Korea, Republic of, 420-717
        • Department of Surgery, Holy Family Hospital, The Catholic University of Korea
      • In Cheon, Korea, Republic of, 403-720
        • Department of Surgery, Our Lady of Mercy Hospital, The Catholic University of Korea
      • Seoul, Korea, Republic of, 137-710
        • Department of Surgery, Kangnam St. Mary's Hospital, The Catholic University of Korea
      • Seoul, Korea, Republic of, 150-713
        • Department of Surgery, St Mary's Hospital, The Catholic University of Korea
      • Suwon, Korea, Republic of, 442-723
        • Department of Surgery, St. Vincent's Hopital, The Catholic University of Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who underwent distal gastrectomy for adenocarcinoma of stomach with following criteria:

    1. have cancer located in middle or distal portions
    2. preoperative staged as cT1N0M0 or cT2N0M0 by computed tomography and gastrofiberscope (Endoscopic ultrasound, optionally)
    3. have The American Society of Anaesthesiologists (ASA) score of three and less

Exclusion Criteria:

  • Patients following criteria:

    1. have simultaneously other cancer
    2. underwent cancer therapy (radiologic or immunologic or chemotherapeutic method) at past time
    3. have systemic inflammatory disease
    4. have upper gastrointestinal surgery
    5. have the gastric cancer with obstruction
    6. get pregnancy
    7. are treating diabetics with Insulin
    8. are participating or participated within 1 month in other clinical trials
    9. have BMI less than 25
    10. are expected to perform laparoscopy assisted gastrectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Billroth-II (B-II)reconstruction
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.
Other Names:
  • B-II
Other: 2
Roux en Y gastrojejunostomy (RY-GJ)
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.
Other Names:
  • RY-GJ
Other: 3
uncut Roux en Y gastrojejunostomy (uncut RY-GJ)
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.
Other Names:
  • uncut RY-GJ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bile reflux by Dual scintigraphy
Time Frame: six month and one year after operation
six month and one year after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Gastric emptying time by Dual scintigraphy
Time Frame: six month and one year after operation
six month and one year after operation
Residual food, gastritis, bile reflux and reflux esophagitis by Gastrofiberscope findings
Time Frame: six month and one year after operation
six month and one year after operation
Quality of life by EORTC QLQ30, STO22
Time Frame: one year after operation
one year after operation
Morbidity and Mortality
Time Frame: In hosipital
In hosipital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wook Kim, MD, PhD, Department of Surgery, Holy Family Hospital, The Catholic University of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (Estimate)

February 25, 2008

Study Record Updates

Last Update Posted (Estimate)

August 3, 2009

Last Update Submitted That Met QC Criteria

July 31, 2009

Last Verified

July 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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