Clinical trial NCT05966246: The Effect of Prucalopride Succinate on Gastrointestinal Motility After Laparoscopic Gastrectomy : Prospective Double Blind Case-control Study
Official title: The Effect of Prucalopride Succinate on Gastrointestinal Motility After Laparoscopic Gastrectomy : Prospective Double Blind Case-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 106
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In order to improve postoperative ileus in patients undergoing gastrointestinal surgery, digestive medications and prokinetics have been routinely used. Among them, mosapride citrate is widely used as a representative drug, as it is a 5-hydroxytryptamine 4 receptor agonist that increases gastrointestinal motility.

Prucalopride succinate (dihydrobenzofurancarboxamide) is a type of 5-hydroxytryptamine 4 receptor agonist that has a higher affinity for the 5-HT4 receptor compared to mosapride (a benzamide derivative) which belongs to the same class of drugs. Prucalopride succinate has been demonstrated to increase both gastric and colonic motility through in vivo and in vitro studies. As mentioned earlier, it exhibits high specificity for the 5-HT4 receptor. The 5-HT4 receptor is not expressed in the gastric mucosa but is expressed at low concentrations in the small intestine, whereas it is highly expressed in the colonic mucosa. Therefore, prucalopride is widely used as a therapeutic agent for chronic constipation by increasing colonic motility. Furthermore, Prucalopride succinate stimulates the 5-HT4 receptors present in the nerve terminals of the myenteric plexus, promoting the release of acetylcholine. The released acetylcholine acts on α7nAch receptors located on the surface of enteric smooth muscle cells, inhibiting inflammatory responses and reducing postoperative ilues.

A randomized controlled trial (RCT) conducted on 110 patients who underwent gastrointestinal surgery demonstrated that prucalopride succinate showed significant improvement in gastrointestinal motility compared to the control group. Currently, mosapride citrate is widely used as a prokinetic agent in clinical practice. However, preliminary studies have shown no significant efficacy, and when comparing abdominal X-ray images taken on the third day after surgery, there is no significant difference compared to the placebo group. As a result, it can be observed that the recovery of gastrointestinal motility after surgery is not primarily due to small bowel motility but rather delayed gas passing caused by colon motility. Therefore, it can be assumed that using drugs that increase colon motility may be effective in improving gastrointestinal motility after surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with gastric adenocarcinoma pathologically before surgery
2. Patients who underwent complete surgical resection (R0 resection)
3. Patients with an ASA score of 3 or less

Exclusion Criteria:

1. Patients over 80 years of age
2. Ascites or peritoneal metastasis
3. If you have intestinal obstruction before surgery
4. If chemotherapy was performed before surgery
5. If cancer other than gastric cancer is diagnosed
6. If there is a history of previous major intra-abdominal long-term surgery or abdominal radiation therapy
7. In case of liver failure or renal failure
8. Pregnant women
9. If it is judged that uncontrolled diabetes can affect intestinal function
10. If you have a stoma

Primary outcomes:
measure: Quantitative intestinal motility measurement using radio-opaque markers
timeFrame: Every day from the 1st day to the 5th day after surgery
Secondary outcomes:
measure: Measurement of the amount of food intake, first flatus time and first defecation time
timeFrame: Every day from the 1st day to the 5th day after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeverance Hospital
Study officials:
References: