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NCT06076252
Modified vs Conventional Blumgart Anastomosis of LPD for the Effects of Pancreatic Fistula of Periampullary Carcinoma
NA trial testing Modified Blumgart Anastomosis in LPD in Ampullary Cancer in 150 participants. Enrolling by invitation.
1 July 2028
Quick facts
| Lead sponsor | Affiliated Hospital of Guangdong Medical University |
|---|---|
| Phase | NA |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 July 2023 |
| Primary completion | 1 July 2028 |
| Estimated completion | 31 August 2028 |
| Sites | 1 location across China |
Drugs / interventions tested
- Modified Blumgart Anastomosis in LPD
- conventional Blumgart anastomosis in LPD
Conditions studied
- Ampullary Cancer — all drugs for Ampullary Cancer →
- Bile Duct Cancer — all drugs for Bile Duct Cancer →
- Pancreas Cancer — all drugs for Pancreas Cancer →
- Duodenum Cancer — all drugs for Duodenum Cancer →
Sponsor
Affiliated Hospital of Guangdong Medical University
Who can join
Adults 18 to 75, any sex, with Ampullary Cancer or Bile Duct Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The incidence rate and mortality rate of periampullary cancer at home and abroad both show an increasing trend, seriously affecting the health level of the people. Pancrecoduodenectomy (PD) is the only effective treatment for periampullary cancer. However, due to the complex technology and difficulty of PD surgery, laparoscopic pancreaticoduodenectomy (LPD) is more difficult, and the postoperative mortality can reach 5%. The important reason is the most serious complication- -pancreatic fistula. The occurrence of pancreatic fistula is related to many factors, and the most critical factor is the method and technology of pancreatico-intestinal anastomosis, so the improvement and innovation of pancreaticoco-intestinal anastomosis technology has always been a hot topic in surgical clinical research. Blumgart Pancreatic anastomosis was originally created by Professor L.H.Blumgart in the United States, and was widely used in OPD due to its low incidence of pancreatic fistula. However, the traditional Blumgart anastomosis is complicated and is not suitable for application in LPD. According to our own experience, our team simplified and improved the traditional Blumgart anastomosis to OPD, and through retrospective study, it has the advantages of reducing the incidence of pancreatic fistula. However, the application value in LPD still needs to be further discussed. Therefore, this study intends to use a prospective randomized controlled trial, using the LPD patients with traditional Blumgart pancreatecointestinal anastomosis as the control group, and the LPD patients with modified Blumgart pancreatecointestinal anastomosis as the test group, compare the clinical relevant indicators and the incidence of postoperative complications, and explore whether the application value in LPD can truly simplify the surgical procedure and ensure the lower incidence of pancreatic leakage.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06076252 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Affiliated Hospital of Guangdong Medical University
- Last refreshed: 10 October 2023
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