The Effect of Prucalopride Succinate on Gastrointestinal Motility After Laparoscopic Gastrectomy : Prospective Double Blind Case-control Study

Gastric Cancer Clinical Trial

Official title:

The Effect of Prucalopride Succinate on Gastrointestinal Motility After Laparoscopic Gastrectomy : Prospective Double Blind Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05966246
• Other study ID #: 3-2021-0480
• Status: Completed
• Phase: N/A
• Start date: January 25, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Arm I : Experimental (Prucalopride succinate group)
Experimental group taking prucalopride succinate from day 1 to day 5 after surgery
• Arm II : Control (Mosapride citrate group)
Control gourp taking mosapride citrate from day 1 day 5 after surgery

Locations

Country	Name	City	State
Korea, Republic of	GangnamSeverance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative intestinal motility measurement using radio-opaque markers		Every day from the 1st day to the 5th day after surgery
Secondary	Measurement of the amount of food intake, first flatus time and first defecation time	Quantitatively compare and analyze the amount of food eaten in the test group and the control group.; Compare the first flatus appearance time and first defecation time in the test group and the control group.	Every day from the 1st day to the 5th day after surgery