Ampullary CancerNCT06076252
Modified vs Conventional Blumgart Anastomosis of LPD for the Effects of Pancreatic Fistula of Periampullary Carcinoma
A study testing Modified Blumgart Anastomosis in LPD and conventional Blumgart anastomosis in LPD in people with Ampullary Cancer and Bile Duct Cancer, run by Affiliated Hospital of Guangdong Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ampullary Cancer, Bile Duct Cancer, Pancreas Cancer
- What is being tested?
- Modified Blumgart Anastomosis in LPD and conventional Blumgart anastomosis in LPD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radically resectable stage I - III low periampullary carcinoma in patients, And all met the following criteria:
- age 18-75 years;
- imaging (upper abdominal MRI, MRCP / CT / CTA) diagnosis of periampullary (duodenal papilla, ampulla, inferior common bile duct, pancreatic head);
- MDT discussion of tumor invasion of large vessels (SMA, CA, CHA/SMV, PV) resectable;
- endoscopic duodenal ultrasound diagnosis of periampullary carcinoma;
- endoscopic biopsy pathology confirmation of carcinoma (not essential);
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- preoperative stage within T3N1;
- no evidence of distant metastasis;
- cardiopulmonary and liver and kidney function can tolerate surgery;
- patients and family members can understand and willing to participate in this study, Provided the written informed consent.
Who cannot join
- Diagnosis of malignant tumors in other sites;
- ASA grade IV and / or ECOG physical strength status score> 2 points;
- Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or severe basic diseases who cannot tolerate surgery;
- Have an uncontrolled preoperative infection;
- Pregnant or lactating women;
- A history of serious mental illness;
- Patients with other clinical and laboratory conditions considered by the investigator are not suitable to participate in this trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong
About this study
Official title: Modified Blumgart vs Conventional Blumgart Anastomosis Technique in the Treatment of Periampulltrary Carcinoma on Postoperative Pancreatic Fistula: an Open, Randomized, Parallel Controlled Clinical Study
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.
Read the detailed description
This study intends to use a prospective randomized controlled trial, the LPD patients with traditional Blumgart anastomosis as the control group, design the LPD patients with modified Blumgart anastomosis as the test group, by comparing the clinical correlation index and the rate of postoperative complications in LPD can truly simplify the surgical procedure and ensure the lower rate of pancreatic leakage.
The following steps will be followed:
- Patients who met the inclusion criteria and did not meet the exclusion criteria underwent modified Blumgart anastomosis according to the randomization LPD surgery group (test group) or LPD surgery group with conventional Blumgart pancreatecreenterostomy (control group).
- The following common LPD procedure was used in the test and control groups: ① Preoperative preparation and anesthesia mode Preoperative gastric tube, urinary tube and central venous channel; general anesthesia ② Same surgical procedure: Establishment of artificial pneumoperitoneum and operating hole anatomical exploratory specimen resection and reconstruction of digestive tract (biliary intestine kiss Combination, gastrointestinal anastomosis) drain placement.
- In the test group, the pancreatic intestine anastomosis in the LPD Combined, the control group used conventional Blumgart pancreatestatic anastomosis.
- Both postoperative groups were routinely given anti-infection, gastric mucosa protection, somatostatin, and nutritional supportive therapy. After the first Remove gastric tube and urinary catheter on 3 days, instructed patients to eat cold liquid food and ambulation; somatostatin was stopped on postoperative day 5, The upper abdominal CTA was reviewed, and the remaining treatment plans were formulated according to the actual situation of the patient. Postoperative numbers 1,3,5, and For 7 days, the relevant drainage indexes, daily drainage rate, drainage properties and amylase content were reviewed.
- If the patient can be discharged with the following conditions: the general condition is good, and the normal diet and intestinal function are basically restored; Body temperature was normal and the abdominal examination showed no positive signs; relevant laboratory results were almost normal; CTA Significant abdominal effusion and other abnormalities; postoperative abdominal incision healed well.
- After discharge, pay attention to their appetite, spirit, urine and feces, and drainage tube (discharged with drainage tube). Patients without special discomfort were returned to the hospital for review once at 1and 3 months after surgery.
- Conditions
- Ampullary Cancer, Bile Duct Cancer, Pancreas Cancer, Duodenum Cancer
- Being tested
- Modified Blumgart Anastomosis in LPD, conventional Blumgart anastomosis in LPD
- Medical subject headings
- Bile Duct Neoplasms, Pancreatic Neoplasms, Duodenal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Blumgart Anastomosis in LPDProcedure or surgery
This study is a clinical study designed by parallel control, the test group is LPD patients with modified Blumgart anastomosis and the control group is LPD patients with conventional Blumgart anastomosis
conventional Blumgart anastomosis in LPDProcedure or surgery
This study is a clinical study designed by parallel control, the test group is LPD patients with modified Blumgart anastomosis and the control group is LPD patients with conventional Blumgart anastomosis
| Study group | Role | What they receive |
|---|---|---|
| Modified Blumgart Anastomosis of LPD | Experimental | The effect of modified Blumgart technique in the treatment of periampulltrary carcinoma on postoperative pancreatic fistula Receives: Procedure: Modified Blumgart Anastomosis in LPD |
| Conventional Blumgart Anastomosis of LPD | Other | The effect of Conventional Blumgart Anastomosis in the treatment of periampulltrary carcinoma on postoperative pancreatic fistula Receives: Procedure: conventional Blumgart anastomosis in LPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of POPF
The rate of Postoperative pancreatic fistula
Measured: 90 Days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ampullary CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Guangdong Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohua Liu, Affiliated Hospital of Guangdong Medical University
- Investigators
- Liu Guohua, Study director, Affiliated Hospital of Guangdong Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076252
- Sponsor's protocol ID
- PJKT2023-061
- Status last verified
- Apr 2023
- First submitted
- 30 Aug 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Blumgart vs Conventional Blumgart Anastomosis Technique in the Treatment of Periampulltrary Carcinoma on Postoperative Pancreatic Fistula: an Open, Randomized, Parallel Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06076252
- Acronym / sponsor ID
- PJKT2023-061
- Conditions
- Ampullary Cancer, Bile Duct Cancer, Pancreas Cancer, Duodenum Cancer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Guangdong Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study intends to use a prospective randomized controlled trial, the LPD patients with traditional Blumgart anastomosis as the control group, design the LPD patients with modified Blumgart anastomosis as the test group, by comparing the clinical correlation index and the rate of postoperative complications in LPD can truly simplify the surgical procedure and ensure the lower rate of pancreatic leakage.
The following steps will be followed:
- Patients who met the inclusion criteria and did not meet the exclusion criteria underwent modified Blumgart anastomosis according to the randomization LPD surgery group (test group) or LPD surgery group with conventional Blumgart pancreatecreenterostomy (control group).
- The following common LPD procedure was used in the test and control groups: ① Preoperative preparation and anesthesia mode Preoperative gastric tube, urinary tube and central venous channel; general anesthesia ② Same surgical procedure: Establishment of artificial pneumoperitoneum and operating hole anatomical exploratory specimen resection and reconstruction of digestive tract (biliary intestine kiss Combination, gastrointestinal anastomosis) drain placement.
- In the test group, the pancreatic intestine anastomosis in the LPD Combined, the control group used conventional Blumgart pancreatestatic anastomosis.
- Both postoperative groups were routinely given anti-infection, gastric mucosa protection, somatostatin, and nutritional supportive therapy. After the first Remove gastric tube and urinary catheter on 3 days, instructed patients to eat cold liquid food and ambulation; somatostatin was stopped on postoperative day 5, The upper abdominal CTA was reviewed, and the remaining treatment plans were formulated according to the actual situation of the patient. Postoperative numbers 1,3,5, and For 7 days, the relevant drainage indexes, daily drainage rate, drainage properties and amylase content were reviewed.
- If the patient can be discharged with the following conditions: the general condition is good, and the normal diet and intestinal function are basically restored; Body temperature was normal and the abdominal examination showed no positive signs; relevant laboratory results were almost normal; CTA Significant abdominal effusion and other abnormalities; postoperative abdominal incision healed well.
- After discharge, pay attention to their appetite, spirit, urine and feces, and drainage tube (discharged with drainage tube). Patients without special discomfort were returned to the hospital for review once at 1and 3 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Blumgart Anastomosis of LPD | Experimental | Procedure: Modified Blumgart Anastomosis in LPDThe effect of modified Blumgart technique in the treatment of periampulltrary carcinoma on postoperative pancreatic fistula |
| Conventional Blumgart Anastomosis of LPD | Other | Procedure: conventional Blumgart anastomosis in LPDThe effect of Conventional Blumgart Anastomosis in the treatment of periampulltrary carcinoma on postoperative pancreatic fistula |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Radically resectable stage I - III low periampullary carcinoma in patients, And all met the following criteria:
- age 18-75 years;
- imaging (upper abdominal MRI, MRCP / CT / CTA) diagnosis of periampullary (duodenal papilla, ampulla, inferior common bile duct, pancreatic head);
- MDT discussion of tumor invasion of large vessels (SMA, CA, CHA/SMV, PV) resectable;
- endoscopic duodenal ultrasound diagnosis of periampullary carcinoma;
Key exclusion criteria (7 listed)
- Diagnosis of malignant tumors in other sites;
- ASA grade IV and / or ECOG physical strength status score> 2 points;
- Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or severe basic diseases who cannot tolerate surgery;
- Have an uncontrolled preoperative infection;
- Pregnant or lactating women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Blumgart Anastomosis in LPDThis study is a clinical study designed by parallel control, the test group is LPD patients with modified Blumgart anastomosis and the control group is LPD patients with conventional Blumgart anastomosis | Procedure or surgery | Modified Blumgart Anastomosis of LPD |
| conventional Blumgart anastomosis in LPDThis study is a clinical study designed by parallel control, the test group is LPD patients with modified Blumgart anastomosis and the control group is LPD patients with conventional Blumgart anastomosis | Procedure or surgery | Conventional Blumgart Anastomosis of LPD |
Primary outcome
The rate of POPF
Time frame: 90 Days after surgery
The rate of Postoperative pancreatic fistula
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liu Guohua study director
Affiliated Hospital of Guangdong Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Blumgart Anastomosis in LPD and conventional Blumgart anastomosis in LPD in people with Ampullary Cancer and Bile Duct Cancer, run by Affiliated Hospital of Guangdong Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of POPF (time frame: 90 Days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.