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Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy

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ClinicalTrials.gov Identifier: NCT01142271
Recruitment Status : Unknown
Verified November 2011 by Sang-Uk Han, Ajou University School of Medicine.
Recruitment status was:  Recruiting
First Posted : June 11, 2010
Last Update Posted : November 7, 2011
Sponsor:
Information provided by (Responsible Party):
Sang-Uk Han, Ajou University School of Medicine

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

Condition or disease Intervention/treatment Phase
Gastrectomy Procedure: Billroth-I Procedure: Roux en Y Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Billroth-I and Roux-en-Y Reconstruction After Distal Subtotal Gastrectomy for Gastric Cancer Patients : Prospective Randomized Study
Study Start Date : June 2010
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Billroth-I
Patients in this group should be underwent gastroduodenostomy as reconstruction procedure after standard distal subtotal gastrectomy with lymph node dissection.
Procedure: Billroth-I
Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, gastroduodenostomy should be performed by circular stapler. In addition, stapler sites were re-enforced.
Other Name: Gastroduodenostomy

Experimental: Roux en Y
Patients in this group should be underwent jejunojejunostomy and gastrojejunostomy as reconstruction procedure after standard distal gastrectomy.
Procedure: Roux en Y
Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, jejunojejunostomy and gastrojejunostomy should be performed by circular staplers. In addition, stapler sites were re-enforced.
Other Name: Gastrojejunostomy and jejunojejunostomy




Primary Outcome Measures :
  1. Reflux of bile content [ Time Frame: 6 months after surgery ]
    We estimate the degree of reflux by gastrofiberscopic findings using reflux score suggested by Romaganoli. In addition, histological finding of remnant stomach by endoscopic biopsy is also investigated. Reflux symptom is surveyed by Gastrointestinal Symptom Rating Scale.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 6 months after surgery ]
    We investigate the quality of life with EORTC-C30, EORTC-STO22 questionnaire suggested by European Organization for Research and Treatment of Cancer (EORTC).

  2. Morbidity [ Time Frame: 2 month after surgery ]
    We investigate the occurrence of complication during recovery after surgery.

  3. Anastomotic time [ Time Frame: Day 1 ]
    We estimate anastomosis time

  4. Nutritional state [ Time Frame: 6 month after surgery ]
    We estimate Albumin, transferrin, lymphocyte, body weight

  5. Mortality [ Time Frame: 2 month after operation ]
    We investigate the occurrence of operation-related death during recovery after surgery.

  6. Operation time [ Time Frame: Day 1 ]
    We estimate total operation time.



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142271


Contacts
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Contact: Hoon Hur, M.D. +82-31-219-2507 hhcmc75@naver.com
Contact: Sang-Uk Han, M.D. +82-31-219-6320 hansu@ajou.ac.kr

Locations
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Korea, Republic of
Ajou University Hospital Recruiting
Suwon, Korea, Republic of, 422-749
Contact: Hoon Hur, M.D.    +82-31-219-5207    hhcmc75@naver.com   
Contact: Jun Young Kim, M.D.    +82-31-219-5206    murmur2@hanmail.net   
Principal Investigator: Sang-Uk Han, M.D., Ph.D.         
Sub-Investigator: Hoon Hur, M.D.         
Sub-Investigator: Young Bae Kim, M.D.         
Sub-Investigator: Jun Young Kim, M.D.         
Sub-Investigator: Sun Mi Uhm, N.R.         
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: Sang-Uk Han, M.D., Ph D. Department of Surgery, Ajou University School of Medicine
Study Director: Hoon Hur, M.D. Department of Surgery, Ajou University School of Medicine