Gastric Cancer Patients Treated by Subtotal Gastrectomy Clinical Trial
| Verified date | January 2009 |
| Source | Samsung Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Korea: Institutional Review Board |
| Study type | Observational |
According to Seoul cancer registry data (2000), cancer became the leading cause of death in
Korea, accounting for 23.9% of all deaths and gastric cancer is the most prevalent malignant
neoplasm, comprising 20.8% of all cancers. Korea and some part of Asian countries have the
highest incidence of gastric cancer in the world. Therefore, gastrectomy became one of the
most common cancer operation in Korea. Thanks to early detection and intervention, the
mortality of early gastric cancer drops dramatically and is now believed to be one of the
most curable diseases among all the cancers. However, after successful operation and the
declaration of cure of the stomach cancer, the patients are left without stomach for all his
remaining life. If the patients lose most of his stomach tissue, there are several problems,
which include loss of reservoir function for food and indigestion. Besides, loss of appetite
is of the paramount importance because the stomach is an important endocrine organ
controlling the appetite via gut-brain axis and the main axis is through a hormone called
ghrelin, the only orexigenic hormone in human.
Because ghrelin is mainly secreted by the fundus and body, operations such as laryngoscopic
Roux-en-Y gastric bypass: (LRYGBP), laryngoscopic-adjustable silicone gastric banding
(LASGB) virtually abolish the ghrelin expressing cells. Thus loss of appetite is an
inevitable consequence. Then what happens of the plasma ghrelin after Billoth surgery
(standard gastric cancer operation) which removes antrum and body of the stomach where
ghrelin expressing cells are relatively less distributed? Also puzzling is the fact that
after surgery some patients start to gain weight while others continue to lose weight and
appetite. Are there ghrelin-expressing cell hyperplasia in the patients who start to gain
weight?
The gastrectomy operation which is performed at the investigators institute is Billoth I or
II operation. The operation virtually eliminate the half of the body and most of the antrum.
If fundus is involved also, proximal gastrectomy is the operation of the choice. Most of the
patients who have these operations will lose weight during 1-3 months after surgery,
thereafter slowly recover. However, the mechanism of the weight recovery has not been
elucidated so far.
To elucidate the mechanism of re-gaining body weight and possible ghrelin expressing cell
hyperplasia, the investigators designed the prospective study to investigate the stomach
tissue as well as plasma ghrelin in the patients who are going to have Billoth surgery. The
items to be investigated include plasma for hormones (ghrelin, leptin, insulin, CCK, PYY),
stomach tissue for ghrelin, diet evaluation and body weight (body mass index) changes for 7
months after gastrectomy.
The investigators hope that their study will reveal the valuable information on the body
weight recovery and appetite issue. So far the issue of the stomach cancer patients was
related to survival issue. However, to lead a comfortable life the quality of life is also
very important. The investigators approach will hint the way of surgery which will benefit
the patients to live a happy life.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | July 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - patients with informed consent - gastric cancer patients treated by subtotal gastrectomy (without chemotherapy or radiation therapy) : Actually the differentiation of EGC or AGC depend on the depth of invasion. Therefore if the patients are not cachetic because of metastasis or tumor burden, there is no need toe exclude the AGC patients from the study. Exclusion Criteria: - patients with chemotherapy or radiation therapy diabetes mellitus: It has been reported that plasma ghrelin is influenced by the insulin. Thus a history of diabetes exclude the enrollment of the protocol. |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Samsung Medical Center |