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

NCT ID: NCT00622804

Last Updated: 2009-08-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31

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).

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.

Conditions

Stomach Cancer; Gastrectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Billroth-II (B-II)reconstruction

Group Type: OTHER

Billroth-II (B-II)

Intervention Type: 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.

2

Roux en Y gastrojejunostomy (RY-GJ)

Group Type: OTHER

Roux en Y gastrojejunostomy (RY-GJ)

Intervention Type: 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.

3

uncut Roux en Y gastrojejunostomy (uncut RY-GJ)

Group Type: OTHER

uncut Roux en Y gastrojejunostomy

Intervention Type: PROCEDURE

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.

Interventions

Billroth-II (B-II)

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

uncut Roux en Y gastrojejunostomy

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.

Intervention Type: PROCEDURE

Other Intervention Names

B-II; RY-GJ; uncut RY-GJ

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Department of Surgery, Holy Family Hospital, College of Medicine

Principal Investigators

Wook Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Bucheon-si, , South Korea

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

Incheon, , South Korea

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

Seoul, , South Korea

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

Seoul, , South Korea

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

Suwon, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 16024924 (View on PubMed)

Other Identifiers

HCHC06OT049

Identifier Type: -

Identifier Source: org_study_id