Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer:

Gastric Cancer Clinical Trial

Official title:

Short-term Results of a Randomized Controlled Trial and Review of the Literature Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer: Short-term Results of a Randomized Controlled Trial and Review of the Literature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06281379
• Other study ID #: Basaksehir City Hospital
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: February 2024
• Source: Basaksehir Cam & Sakura Sehir Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: To define complete mesogastric excision and compare our short term results for the first time in a different population.

Study design:Randomised-controlled study

Place and duration of the study: Gastroenterological Surgery Clinic,Health Sciences University,Basaksehir City Hospital,Istanbul,Turkey,from April to December 2023.

Methodology: We compared short term results of open total gastrectomy+ mesogastrectomy with standard total gastrectomy + D2 lymph node dissection at a tertiary center in terms of peroperative results, histopathological findings and postoperative short- term outcomes with review of the literature.

Conclusion: Our aim is to show that mesogastric excision is safe and has advantages over conventional D2 gastrectomy in means of not only peroperative and short-term outcomes, but also disease free survival.Our work is the first study from a different population of the world and our initial results can contribute to the literature for universalization.

Description:

The curative treatment of gastrointestinal tumors is surgery referring to an en block resection of the primary tumor along with its lymphovascular drainage.Unfortunately, despite of these radical resections, published literature shows that recurrences occur in up to 38% of patients in 5 years. Morover, these rates may reach to 60% in patients with locally advanced tumor following radical surgery. However, this mesentery-based surgery is harder to apply in gastric cancer due to differences in embriyological development. In our prospective study and a review of the literature, following the descripiton of mesogastrium concept, we aimed to search and analyse former techniques and viewpoints about mesogastric excision by different surgical approaches from various countries. Later, we aimed to show our technique of mesogastrectomy, compared our short term results with limited publications from the literature.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with histopathologically confirmed gastric adenocancer without evidence of distal metastasis and resectable tumors which have been treated with open total gastrectomy.

Exclusion Criteria:

• Patients with prior upper gastrointestinal system surgery

• Patients with neoadjuvant therapy

• Patients with peripheral organ involvement and/or distant metastasis

• Patients who underwent subtotal gastrectomy

• Patients who underwent laparoscopic and robotic operations

Related Conditions & MeSH terms

• Gastric Cancer
• Gastric Cancer Stage
• Gastric Neoplasm
• Stomach Neoplasms

Intervention

Procedure:
• Total mesogastrectomy
More extended resection type with better oncological outcomes when compared to standard technique

Locations

Country	Name	City	State
Turkey	Yigit Duzkoylu	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Basaksehir Cam & Sakura Sehir Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Girnyi S, Ekman M, Marano L, Roviello F, Polom K. Complete Mesogastric Excisions Involving Anatomically Based Concepts and Embryological-Based Surgeries: Current Knowledge and Future Challenges. Curr Oncol. 2021 Nov 22;28(6):4929-4937. doi: 10.3390/curroncol28060413. — View Citation

Shinohara H, Kurahashi Y, Haruta S, Ishida Y, Sasako M. Universalization of the operative strategy by systematic mesogastric excision for stomach cancer with that for total mesorectal excision and complete mesocolic excision colorectal counterparts. Ann Gastroenterol Surg. 2017 Oct 23;2(1):28-36. doi: 10.1002/ags3.12048. eCollection 2018 Jan. — View Citation

Xie D, Gao C, Lu A, Liu L, Yu C, Hu J, Gong J. Proximal segmentation of the dorsal mesogastrium reveals new anatomical implications for laparoscopic surgery. Sci Rep. 2015 Nov 6;5:16287. doi: 10.1038/srep16287. — View Citation

Xie D, Osaiweran H, Liu L, Wang X, Yu C, Tong Y, Hu J, Gong J. Mesogastrium: a fifth route of metastasis in gastric cancer? Med Hypotheses. 2013 Apr;80(4):498-500. doi: 10.1016/j.mehy.2012.12.020. Epub 2013 Feb 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative outcome	Complications	Postoperative 1 week