Periampullary CancerNCT04289831
Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors
A study testing Preoperative Biliary Drainage (PBD) and Surgery in people with Periampullary Cancer and Biliary Obstruction, run by University of Alexandria.
Trial summary
The impact of preoperative biliary drainage (PBD) on morbidity and mortality associated with Pancreaticoduodenectomy (PD) in patients with peri-ampulary tumors is still controversial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Periampullary Cancer, Biliary Obstruction, Preoperative Biliary Drainage
- What is being tested?
- Preoperative Biliary Drainage (PBD) and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Serum bilirubin level above 4 mg/dl
- suspected peri-ampullary tumor at computed tomography (CT)
- No evidence of distant metastasis or locally advanced tumor
Who cannot join
- Patients with evidence of distant metastasis or locally advanced tumor
- Prior neoadjuvant chemotherapy or Radiotherapy
- Prior biliary surgery
- Patients with contraindication for major surgery
About this study
Official title: "Impact of Preoperative Biliary Drainage on Surgical and Oncologic Outcomes After Pancreatico-Duodenectomy in Patients With Operable Malignant Periampulary Tumors. A Randomized Controlled Study"
The impact of preoperative biliary drainage (PBD) on morbidity and mortality associated with Pancreaticoduodenectomy (PD) in patients with peri-ampulary tumors is still controversial. The objective of this study is to evaluate the impact of PBD on surgical and oncologic outcomes after PD in jaundiced patients with operable peri-ampulary tumors.
Read the detailed description
150 consecutive jaundiced patients with suspected operable peri-ampullary tumors were randomized via concealed envelopes into 2 groups (each included 75 patients), group I managed by direct surgery while group II managed by PBD followed by surgery. Both groups were compared regarding perioperative mortality, morbidities, tumor recurrence and 2 years survival rates.
- Being tested
- Preoperative Biliary Drainage (PBD), Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Biliary Drainage (PBD)Procedure or surgery
Endoscopic retrograde biliary drainage (ERBD) and stent placement was the first choice for PBD while ultrasound-guided percutaneous transhepatic biliary drainage (PTBD) was done if ERBD was not feasible. Biliary drainage was considered successful if the serum bilirubin level decreased by 50% or more within 2 weeks after the procedure. Patients with failed PBD were referred directly to surgery, while those with successful PBD were referred to surgery 4 to 6 weeks after first drainage procedure according to the latest guidelines
SurgeryProcedure or surgery
The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy
| Study group | Role | What they receive |
|---|---|---|
| Direct Surgery (DS) group | Active comparator | patients subjected to direct surgery (DS) within 1 week after randomization Receives: Procedure: Surgery |
| Preoperative Biliary Drainage (PBD) group | Active comparator | patients managed by Preoperative Biliary Drainage followed by surgery after 4-6 weeks. Receives: Procedure: Preoperative Biliary Drainage (PBD); Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early postoperative mortality (within 3 months)
Death within 90 days postoperatively
Measured: within 90 days after surgery
Early postoperative morbidities (within 3 months)
Any complications related to surgery within 3 months including: postoperative bleeding, pancreatic fistula, Biliary leakage, Intra-abdominal infection, wound infection/ dehiscence
Measured: within 90 days after surgery
Secondary outcomes (3)
Tumor recurrence
Local or systemic recurrence of the malignant tumor
Measured: 2 years follow up after surgery
Disease free survival (DFS)
% of patients survived without any evidence of tumor recurrence after 2 years follow up
Measured: 2 years follow up after surgery
Overall survival (OS)
% of patients survived with or without tumor recurrence after 2 years follow up
Measured: 2 years follow up after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study startAug 2015
- Primary completionOct 2017
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periampullary 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El Messiry, University of Alexandria
- Investigators
- Mohamed M Elmessiry, MD,PhD, Principal investigator, Ass. Professor of Surgery (Surgical Oncology Unit)Eman A Mohamed, MD, PhD, Principal investigator, Lecturer of Internal Medicine (Gastroenterology Unit)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289831
- Sponsor's protocol ID
- 03027612
- Status last verified
- Feb 2020
- First submitted
- 27 Feb 2020
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang C, Xu Y, Lu X. Should preoperative biliary drainage be routinely performed for obstructive jaundice with resectable tumor? Hepatobiliary Surg Nutr. 2013 Oct;2(5):266-71. doi: 10.3978/j.issn.2304-3881.2013.09.01.
PubMed 24570957Mezhir JJ, Brennan MF, Baser RE, D'Angelica MI, Fong Y, DeMatteo RP, Jarnagin WR, Allen PJ. A matched case-control study of preoperative biliary drainage in patients with pancreatic adenocarcinoma: routine drainage is not justified. J Gastrointest Surg. 2009 Dec;13(12):2163-9. doi: 10.1007/s11605-009-1046-9. Epub 2009 Sep 23.
PubMed 19774424Smith RA, Dajani K, Dodd S, Whelan P, Raraty M, Sutton R, Campbell F, Neoptolemos JP, Ghaneh P. Preoperative resolution of jaundice following biliary stenting predicts more favourable early survival in resected pancreatic ductal adenocarcinoma. Ann Surg Oncol. 2008 Nov;15(11):3138-46. doi: 10.1245/s10434-008-0148-z. Epub 2008 Sep 12.
PubMed 18787902Abdullah SA, Gupta T, Jaafar KA, Chung YF, Ooi LL, Mesenas SJ. Ampullary carcinoma: effect of preoperative biliary drainage on surgical outcome. World J Gastroenterol. 2009 Jun 21;15(23):2908-12. doi: 10.3748/wjg.15.2908.
PubMed 19533815
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Impact of Preoperative Biliary Drainage on Surgical and Oncologic Outcomes After Pancreatico-Duodenectomy in Patients With Operable Malignant Periampulary Tumors. A Randomized Controlled Study"
- ClinicalTrials.gov ID
- NCT04289831
- Acronym / sponsor ID
- 03027612
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 28 Feb 2020 (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 impact of preoperative biliary drainage (PBD) on morbidity and mortality associated with Pancreaticoduodenectomy (PD) in patients with peri-ampulary tumors is still controversial. The objective of this study is to evaluate the impact of PBD on surgical and oncologic outcomes after PD in jaundiced patients with operable peri-ampulary tumors.
Detailed description
150 consecutive jaundiced patients with suspected operable peri-ampullary tumors were randomized via concealed envelopes into 2 groups (each included 75 patients), group I managed by direct surgery while group II managed by PBD followed by surgery. Both groups were compared regarding perioperative mortality, morbidities, tumor recurrence and 2 years survival rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Surgery (DS) group | Active comparator | Procedure: Surgerypatients subjected to direct surgery (DS) within 1 week after randomization |
| Preoperative Biliary Drainage (PBD) group | Active comparator | Procedure: Preoperative Biliary Drainage (PBD), Procedure: Surgerypatients managed by Preoperative Biliary Drainage followed by surgery after 4-6 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Serum bilirubin level above 4 mg/dl
- suspected peri-ampullary tumor at computed tomography (CT)
- No evidence of distant metastasis or locally advanced tumor
Key exclusion criteria (4 listed)
- Patients with evidence of distant metastasis or locally advanced tumor
- Prior neoadjuvant chemotherapy or Radiotherapy
- Prior biliary surgery
- Patients with contraindication for major surgery
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 |
|---|---|---|
| Preoperative Biliary Drainage (PBD)Endoscopic retrograde biliary drainage (ERBD) and stent placement was the first choice for PBD while ultrasound-guided percutaneous transhepatic biliary drainage (PTBD) was done if ERBD was not feasible. Biliary drainage was considered successful if the serum bilirubin level decreased by 50% or more within 2 weeks after the procedure. Patients with failed PBD were referred directly to surgery, while those with successful PBD were referred to surgery 4 to 6 weeks after first drainage procedure according to the latest guidelines | Procedure or surgery | Preoperative Biliary Drainage (PBD) group |
| SurgeryThe standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy | Procedure or surgery | Direct Surgery (DS) group, Preoperative Biliary Drainage (PBD) group |
Primary outcome
Early postoperative mortality (within 3 months)
Time frame: within 90 days after surgery
Death within 90 days postoperatively
Early postoperative morbidities (within 3 months)
Time frame: within 90 days after surgery
Any complications related to surgery within 3 months including: postoperative bleeding, pancreatic fistula, Biliary leakage, Intra-abdominal infection, wound infection/ dehiscence
3 secondary outcomes
Tumor recurrence
Time frame: 2 years follow up after surgery
Disease free survival (DFS)
Time frame: 2 years follow up after surgery
Overall survival (OS)
Time frame: 2 years follow up after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Background: PubMed 24570957Wang C, Xu Y, Lu X. Should preoperative biliary drainage be routinely performed for obstructive jaundice with resectable tumor? Hepatobiliary Surg Nutr. 2013 Oct;2(5):266-71. doi: 10.3978/j.issn.2304-3881.2013.09.01.
- Background: PubMed 19774424Mezhir JJ, Brennan MF, Baser RE, D'Angelica MI, Fong Y, DeMatteo RP, Jarnagin WR, Allen PJ. A matched case-control study of preoperative biliary drainage in patients with pancreatic adenocarcinoma: routine drainage is not justified. J Gastrointest Surg. 2009 Dec;13(12):2163-9. doi: 10.1007/s11605-009-1046-9. Epub 2009 Sep 23.
- Background: PubMed 18787902Smith RA, Dajani K, Dodd S, Whelan P, Raraty M, Sutton R, Campbell F, Neoptolemos JP, Ghaneh P. Preoperative resolution of jaundice following biliary stenting predicts more favourable early survival in resected pancreatic ductal adenocarcinoma. Ann Surg Oncol. 2008 Nov;15(11):3138-46. doi: 10.1245/s10434-008-0148-z. Epub 2008 Sep 12.
- Background: PubMed 19533815Abdullah SA, Gupta T, Jaafar KA, Chung YF, Ooi LL, Mesenas SJ. Ampullary carcinoma: effect of preoperative biliary drainage on surgical outcome. World J Gastroenterol. 2009 Jun 21;15(23):2908-12. doi: 10.3748/wjg.15.2908.
- 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. This study is not recruiting at the moment.
Mohamed M Elmessiry, MD,PhD principal investigator
Ass. Professor of Surgery (Surgical Oncology Unit)
Eman A Mohamed, MD, PhD principal investigator
Lecturer of Internal Medicine (Gastroenterology Unit)
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Biliary Drainage (PBD) and Surgery in people with Periampullary Cancer and Biliary Obstruction, run by University of Alexandria.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Early postoperative mortality (within 3 months) (time frame: within 90 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04289831, which also lists 4 linked publications.
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 28 Feb 2020.