| CTRI Number |
CTRI/2019/06/019752 [Registered on: 19/06/2019] Trial Registered Prospectively |
| Last Modified On: |
20/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Endoscopic intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Precut sphincterotomy versus Endoscopic ultrasonography guided rendezvous technique for distal biliary malignancy |
|
Scientific Title of Study
|
Randomized study of precut sphincterotomy versus Endoscopic ultrasonography guided rendezvous technique (EUS-RV) among patients with failed cannulation for distal biliary malignancy during endoscopic retrograde cholangiopancreaticography |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Maydeo |
| Designation |
Director |
| Affiliation |
Baldota Institute of Digestive Sciences |
| Address |
Room No 1, Department of Digestive Sciences, Third Floor, Global hospitals, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02267670311 |
| Fax |
|
| Email |
amitmaydeo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Maydeo |
| Designation |
Director |
| Affiliation |
Baldota Institute of Digestive Sciences |
| Address |
Room No 1, Department of Digestive Sciences, Third Floor, Global hospitals, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02267670311 |
| Fax |
|
| Email |
amitmaydeo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Maydeo |
| Designation |
Director |
| Affiliation |
Baldota Institute of Digestive Sciences |
| Address |
Room No 1 (Chairmans Chambers) Department of Digestive Sciences, Third Floor, Global hospitals, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02267670311 |
| Fax |
|
| Email |
amitmaydeo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Endoscopy Research Foundation, Om chambers, 123 August Kranti Marg, Mumbai - 400036 |
|
|
Primary Sponsor
|
| Name |
Endoscopy Research Foundation |
| Address |
Om Chambers, 123 August Kranti Marg, Mumbai, 400036 |
| Type of Sponsor |
Other [Research Foundation] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amit Maydeo |
Baldota Institute of Digestive Sciences |
Room No 301, Third floor, Global Hospitals, Parel, Mumbai - 400012
Mumbai
MAHARASHTRA |
02267670311
amitmaydeo@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
EUS-guided rendezvous group |
Following the evaluation of the biliary system using a linear echoendoscope, either an extrahepatic biliary duct (EHBD) or an intrahepatic biliary duct (IHBD) will be punctured with a 19-gauge needle. After puncturing the bile duct, contrast medium will be injected into the bile duct to confirm the anatomy. A guide wire will then be advanced through the needle and manipulated antegrade into the small bowel via the native ampulla. The needle and echoendoscope will then be exchanged for a duodenoscope while keeping the guide wire in place. A rendezvous technique can then be performed by grasping the wire using snare or rat tooth. Alternatively a sphincterotome or a cannula will then be inserted through the papilla by the side of the antegradely placed guide wire. |
| Intervention |
Precut sphincterotomy group |
Precut sphincterotomy consists of an incision in the papilla in the absence of free biliary cannulation. The incision is performed most frequently with a needle-tip sphincterotome. Standard and modified techniques have been described, but we will be using “standard†technique.
The incision starts at the orifice and proceeds upwards, in the direction of 11 o clock. The length of the cut is determined by the intraduodenal part of the common bile duct: it stops at the upper limit of the duodenal bulge of the common bile duct. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged 18-70 years
2. Patients with distal bile duct malignant obstruction with a failed cannulation during ERCP
3. Patients who sign the informed consent form |
|
| ExclusionCriteria |
| Details |
1. Patients with duodenal obstruction, inflammatory head mass of pancreas
2. Patients with an inaccessible ampulla of Vater
3. Surgically altered anatomy precluding ERCP
4. Pregnancy
5. Past history of pancreatic surgery or other malignancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Technical success and Clinical success |
At end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes include -Procedure time, number of procedures and adverse events |
At end of study |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/06/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Difficult biliary access is defined as the inability to achieve selective biliary cannulation by standard ERCP techniques within 10 minutes or up to 5 cannulation attempts, or failure of access to the major papilla. The endoscopic approach to the ampulla followed by selective deep biliary cannulation is the first step before further therapy. In normal anatomy, about 11% of therapeutic ERCPs may be considered difficult biliary cannulation. Biliary access in patients with surgically altered anatomy, such as Billroth II or Roux-en-Y anastomosis, is considered difficult because special instruments and maneuvers are often needed. Various methods are used to overcome difficult biliary access such as double guide wire-induced cannulation, precut papillotomy, or transpancreatic sphincterotomy with or without placement of a pancreatic stent. These have been used to improve cannulation success rates and have shown good clinical results. But these techniques and procedures are more complex and carry significant risks, requiring specific training. Although precut sphincterotomy ensures over 90% success of biliary cannulation, it has been characterized as an independent risk factor for pancreatitis. It is also reported that precut sphincterotomy increases morbidity when performed in patients without dilatation of their biliary tract. Nevertheless, precut sphincterotomy is a good alternative method in the setting of a failed standard cannulation method. We aim to study the outcome of precut sphincterotomy versus Endoscopic ultrasonography guided rendezvous technique (EUS-RV) among patients with distal biliary malignant obstruction who have failed cannulation during endoscopic retrograde cholangiopancreaticography in a randomized manner. |